Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial (POINT)

• ClinicalTrials.gov Identifier: NCT00991029
• Recruitment Status: Terminated
• First Posted: October 7, 2009
• Results First Posted: December 4, 2018
• Last Update Posted: December 4, 2018
• Sponsor: University of California, San Francisco
• Collaborators: Neurological Emergencies Treatment Trials Network (NETT); Medical University of South Carolina; The Emmes Company, LLC
• Information provided by (Responsible Party): University of California, San Francisco

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Ischemic Attack, Transient
• Interventions: Drug: Clopidogrel; Drug: placebo
• Enrollment: 4881

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Period Title: Overall Study
Started	2432	2449
Completed	2276	2281
Not Completed	156	168

Baseline Characteristics

Arm/Group Title		Clopidogrel	Placebo	Total
Arm/Group Description		Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days	Total of all reporting groups
Overall Number of Baseline Participants		2432	2449	4881
Baseline Analysis Population Description		[Not Specified]
Age, Continuous [1]; Median (Inter-Quartile Range); Unit of measure: Years
	Number Analyzed	2432 participants	2449 participants	4881 participants
		65.0; (55.0 to 74.0)	65.0; (56.0 to 74.0)	65.0; (55.0 to 74.0)
		[1] Measure Description: Age at time of randomization
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2432 participants	2449 participants	4881 participants
	Female	1097 45.1%	1098 44.8%	2195 45.0%
	Male	1335 54.9%	1351 55.2%	2686 55.0%
Ethnicity (NIH/OMB) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2432 participants	2449 participants	4881 participants
	Hispanic or Latino	144 5.9%	146 6.0%	290 5.9%
	Not Hispanic or Latino	2176 89.5%	2182 89.1%	4358 89.3%
	Unknown or Not Reported	112 4.6%	121 4.9%	233 4.8%
		[1] Measure Description: Race or ethnic group was determined by the investigator. Hispanic ethnic group was assessed only in patients in the United States.
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2432 participants	2449 participants	4881 participants
	American Indian or Alaska Native	7 0.3%	16 0.7%	23 0.5%
	Asian	77 3.2%	67 2.7%	144 3.0%
	Native Hawaiian or Other Pacific Islander	10 0.4%	5 0.2%	15 0.3%
	Black or African American	473 19.4%	493 20.1%	966 19.8%
	White	1774 72.9%	1781 72.7%	3555 72.8%
	More than one race	4 0.2%	5 0.2%	9 0.2%
	Unknown or Not Reported	87 3.6%	82 3.3%	169 3.5%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
New Zealand	Number Analyzed	2432 participants	2449 participants	4881 participants
		3 0.1%	4 0.2%	7 0.1%
Canada	Number Analyzed	2432 participants	2449 participants	4881 participants
		121 5.0%	119 4.9%	240 4.9%
United States	Number Analyzed	2432 participants	2449 participants	4881 participants
		2014 82.8%	2029 82.9%	4043 82.8%
Finland	Number Analyzed	2432 participants	2449 participants	4881 participants
		25 1.0%	25 1.0%	50 1.0%
Mexico	Number Analyzed	2432 participants	2449 participants	4881 participants
		5 0.2%	4 0.2%	9 0.2%
United Kingdom	Number Analyzed	2432 participants	2449 participants	4881 participants
		33 1.4%	38 1.6%	71 1.5%
Australia	Number Analyzed	2432 participants	2449 participants	4881 participants
		53 2.2%	51 2.1%	104 2.1%
France	Number Analyzed	2432 participants	2449 participants	4881 participants
		51 2.1%	47 1.9%	98 2.0%
Germany	Number Analyzed	2432 participants	2449 participants	4881 participants
		8 0.3%	10 0.4%	18 0.4%
Spain	Number Analyzed	2432 participants	2449 participants	4881 participants
		119 4.9%	122 5.0%	241 4.9%
Qualifying Event [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2432 participants	2449 participants	4881 participants
	TIA	1056 43.4%	1052 43.0%	2108 43.2%
	Ischemic Stroke	1376 56.6%	1397 57.0%	2773 56.8%
		[1] Measure Description: TIA or Ischemic Stroke
Qualifying Neurologic Score [1] [2]; Median (Inter-Quartile Range); Unit of measure: Units on a scale
ABCD2	Number Analyzed	1055 participants	1049 participants	2104 participants
		5.0; (4.0 to 6.0)	5.0; (4.0 to 5.0)	5.0; (4.0 to 6.0)
National Institutes of Health Stroke Scale	Number Analyzed	1365 participants	1385 participants	2750 participants
		2.0; (1.0 to 2.0)	2.0; (1.0 to 2.0)	2.0; (1.0 to 2.0)
		[1] Measure Description: The ABCD2 score is a seven-point score for identifying patients who have suffered a transient ischemic attack (TIA) at the highest risk of stroke (scores ranges from 0 to 7, with higher scores indicating a greater risk of stroke). The National Institutes of Health Stroke Scale (NIHSS) score is used quantify the impairment caused by a stroke (scores range from 0 to 42, with higher scores indicating greater stroke severity). Patients were eligible if they had an acute ischemic stroke with a score of 3 or less on the NIHSS or had a TIA with a score of 4 or more on the ABCD2 scale.; [2] Measure Analysis Population Description: ABCD2 scores were available for 2104 of the 2108 patients with TIA (1055 patients in the clopidogrel group and 1049 in the placebo group). NIHSS scores were available for 2750 of the 2773 patients with ischemic stroke (1365 patients in the clopidogrel group and 1385 in the aspirin group).

Outcome Measures

1. Primary Outcome

Title	Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes
Description	Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes
Time Frame	Up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	121 5.0%	160 6.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.02
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.59 to 0.95
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Major Hemorrhage
Description	Primary safety outcome: Number of Participants with major hemorrhage
Time Frame	Up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	23 0.9%	10 0.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.02
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	2.32
	Confidence Interval	(2-Sided) 95%; 1.10 to 4.87
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Ischemic Stroke
Description	Secondary efficacy outcome:Number of participants with Ischemic stroke
Time Frame	Up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	112 4.6%	155 6.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.56 to 0.92
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Myocardial Infarction
Description	Secondary efficacy outcome: Number of participants with Myocardial infarction
Time Frame	Up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	10 0.4%	7 0.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.46
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.44
	Confidence Interval	(2-Sided) 95%; 0.55 to 3.78
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Death From Ischemic Vascular Causes
Description	Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes
Time Frame	Up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	6 0.2%	4 0.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.52
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.51
	Confidence Interval	(2-Sided) 95%; 0.43 to 5.35
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Ischemic or Hemorrhagic Stroke
Description	Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke
Time Frame	Up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	116 4.8%	156 6.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; 0.58 to 0.94
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage
Description	Secondary efficacy outcome: Number of participants with ischemic stroke, myocardial infarction, death from ischemic vascular causes, or major hemorrhage
Time Frame	Up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	141 5.8%	167 6.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.13
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.05
	Estimation Comments	[Not Specified]

8. Other Pre-specified Outcome

Title	Hemorrhagic Stroke
Description	Other safety outcome: Number of participants with Hemorrhagic stroke
Time Frame	up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	5 0.2%	3 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.47
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.68
	Confidence Interval	(2-Sided) 95%; 0.4 to 7.03
	Estimation Comments	[Not Specified]

9. Other Pre-specified Outcome

Title	Symptomatic Intracerebral Hemorrhage
Description	Other safety outcome: Number of participants with Symptomatic intracerebral hemorrhage
Time Frame	up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	2 0.1%	2 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.99
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.14 to 7.14
	Estimation Comments	[Not Specified]

10. Other Pre-specified Outcome

Title	Other Symptomatic Intracranial Hemorrhage
Description	Other safety outcome: Number of participants with other symptomatic intracranial hemorrhage
Time Frame	up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	2 0.1%	0 0.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.16
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

11. Other Pre-specified Outcome

Title	Major Hemorrhage Other Than Intracranial Hemorrhage
Description	Other safety outcome: Number of Participants with Major hemorrhage other than intracranial hemorrhage
Time Frame	up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	17 0.7%	7 0.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.04
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	2.45
	Confidence Interval	(2-Sided) 95%; 1.01 to 5.9
	Estimation Comments	[Not Specified]

12. Other Pre-specified Outcome

Title	Minor Hemorrhage
Description	Other safety outcome:Number of Participants with Minor hemorrhage
Time Frame	up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	40 1.6%	13 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	3.12
	Confidence Interval	(2-Sided) 95%; 1.67 to 5.83
	Estimation Comments	[Not Specified]

13. Other Pre-specified Outcome

Title	Death From Any Cause
Description	Other safety outcome: Number of Participants with Death from any cause
Time Frame	up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clopidogrel	Placebo
Arm/Group Description:	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Number of Participants Analyzed	2432	2449
Measure Type: Count of Participants; Unit of Measure: Participants
	18 0.7%	12 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Clopidogrel, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.27
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.51
	Confidence Interval	(2-Sided) 95%; 0.73 to 3.13
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	90 days from randomization
Adverse Event Reporting Description	Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Arm/Group Title	Clopidogrel		Placebo
Arm/Group Description	Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days		Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
All-Cause Mortality
	Clopidogrel		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	18/2432 (0.74%)		12/2449 (0.49%)
Serious Adverse Events
	Clopidogrel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	382/2432 (15.71%)		382/2449 (15.60%)
Blood and lymphatic system disorders
Anaemia † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Leukocytosis † 1	0/2432 (0.00%)	0	2/2449 (0.08%)	2
Cardiac disorders
Acute coronary syndrome † 1	2/2432 (0.08%)	2	1/2449 (0.04%)	1
Acute myocardial infarction † 1	2/2432 (0.08%)	2	1/2449 (0.04%)	1
Angina pectoris † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Angina unstable † 1	0/2432 (0.00%)	0	2/2449 (0.08%)	2
Arrhythmia † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Atrial fibrillation † 1	24/2432 (0.99%)	24	15/2449 (0.61%)	15
Atrial flutter † 1	0/2432 (0.00%)	0	2/2449 (0.08%)	2
Atrioventricular block † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Atrioventricular block complete † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Bradycardia † 1	2/2432 (0.08%)	2	1/2449 (0.04%)	1
Cardiac arrest † 1	2/2432 (0.08%)	2	1/2449 (0.04%)	1
Cardiac failure † 1	3/2432 (0.12%)	3	0/2449 (0.00%)	0
Cardiac failure congestive † 1	3/2432 (0.12%)	3	0/2449 (0.00%)	0
Cardio-respiratory arrest † 1	2/2432 (0.08%)	2	1/2449 (0.04%)	1
Cardiomyopathy acute † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Congestive cardiomyopathy † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Coronary artery disease † 1	4/2432 (0.16%)	4	1/2449 (0.04%)	1
Heart valve incompetence † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Hypertrophic cardiomyopathy † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Intracardiac thrombus † 1	3/2432 (0.12%)	3	4/2449 (0.16%)	4
Ischaemic cardiomyopathy † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Left ventricular dysfunction † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Myocardial infarction † 1	3/2432 (0.12%)	3	5/2449 (0.20%)	5
Pericardial effusion † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Supraventricular tachycardia † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Ventricular tachycardia † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Congenital, familial and genetic disorders
Atrial septal defect † 1	2/2432 (0.08%)	2	2/2449 (0.08%)	2
Ear and labyrinth disorders
Vertigo † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Vertigo positional † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Eye disorders
Amaurosis fugax † 1	0/2432 (0.00%)	0	2/2449 (0.08%)	3
Retinal artery occlusion † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Vitreous haemorrhage † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Gastrointestinal disorders
Abdominal pain † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Colitis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Constipation † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Diarrhoea † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Diverticulum † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Duodenal ulcer † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Dyspepsia † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Dysphagia † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Faecaloma † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Gastric ulcer † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Gastric ulcer haemorrhage † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Gastrointestinal haemorrhage † 1	10/2432 (0.41%)	11	1/2449 (0.04%)	2
Haemorrhoids † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Impaired gastric emptying † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Intestinal ischaemia † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Intestinal obstruction † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Melaena † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Nausea † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Pancreatitis † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Pancreatitis acute † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Rectal haemorrhage † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Small intestinal obstruction † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Upper gastrointestinal haemorrhage † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Vomiting † 1	0/2432 (0.00%)	0	2/2449 (0.08%)	2
General disorders
Asthenia † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Cardiac death † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Chest discomfort † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Chest pain † 1	13/2432 (0.53%)	13	2/2449 (0.08%)	2
Death † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Fatigue † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Implant site haemorrhage † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Non-cardiac chest pain † 1	0/2432 (0.00%)	0	2/2449 (0.08%)	2
Oedema peripheral † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Pyrexia † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Hepatobiliary disorders
Cholecystitis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Cholecystitis acute † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Hyperbilirubinaemia † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Immune system disorders
Hypersensitivity † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Infections and infestations
Cellulitis † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Cytomegalovirus infection † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Endocarditis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Gastroenteritis † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Gastrointestinal infection † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Influenza † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Lobar pneumonia † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Localised infection † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Meningitis leptospiral † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Neurosyphilis † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Pneumococcal sepsis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Pneumonia † 1	7/2432 (0.29%)	7	3/2449 (0.12%)	3
Pneumonia influenzal † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Pyelonephritis † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Pyelonephritis acute † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Sepsis † 1	4/2432 (0.16%)	5	4/2449 (0.16%)	4
Sinusitis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Urinary tract infection † 1	6/2432 (0.25%)	6	1/2449 (0.04%)	1
Urosepsis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Injury, poisoning and procedural complications
Ankle fracture † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Contusion † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Craniocerebral injury † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Fall † 1	4/2432 (0.16%)	4	2/2449 (0.08%)	2
Femoral neck fracture † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Femur fracture † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Hip fracture † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Multiple fractures † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Patella fracture † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Rib fracture † 1	1/2432 (0.04%)	1	2/2449 (0.08%)	2
Subdural haematoma † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Tibia fracture † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Wrist fracture † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Investigations
Aspiration bronchial † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Catheterisation cardiac † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Troponin increased † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Metabolism and nutrition disorders
Dehydration † 1	2/2432 (0.08%)	2	2/2449 (0.08%)	2
Diabetic ketoacidosis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Electrolyte imbalance † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Failure to thrive † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Hyperglycaemia † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Hypoglycaemia † 1	2/2432 (0.08%)	2	2/2449 (0.08%)	2
Hypokalaemia † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Hyponatraemia † 1	1/2432 (0.04%)	2	0/2449 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Arthritis reactive † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Back pain † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Cervical spinal stenosis † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Costochondritis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Intervertebral disc degeneration † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Musculoskeletal chest pain † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Polymyalgia rheumatica † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Spinal osteoarthritis † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Bladder cancer † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Brain neoplasm † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Carcinoid tumour † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Carotid body tumour † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Lung adenocarcinoma † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Lung neoplasm † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Lung neoplasm malignant † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Metastases to central nervous system † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Metastases to meninges † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Neoplasm malignant † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Non-small cell lung cancer † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Oesophageal carcinoma † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Pancreatic carcinoma † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Small intestine carcinoma † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Nervous system disorders
Balance disorder † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Carotid artery dissection † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Carotid artery stenosis † 1	10/2432 (0.41%)	10	17/2449 (0.69%)	17
Central nervous system lesion † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Cerebellar infarction † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Cerebral artery stenosis † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Cerebral haemorrhage † 1	1/2432 (0.04%)	1	2/2449 (0.08%)	2
Cerebral infarction † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Cerebral ischaemia † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Cerebral venous thrombosis † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Cerebrovascular accident † 1	18/2432 (0.74%)	18	22/2449 (0.90%)	24
Cognitive disorder † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Complex partial seizures † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Complicated migraine † 1	0/2432 (0.00%)	0	3/2449 (0.12%)	3
Convulsion † 1	9/2432 (0.37%)	10	10/2449 (0.41%)	10
Diabetic hyperglycaemic coma † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Dizziness † 1	0/2432 (0.00%)	0	2/2449 (0.08%)	2
Dysarthria † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Embolic stroke † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Encephalopathy † 1	5/2432 (0.21%)	5	0/2449 (0.00%)	0
Epilepsy † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Guillain-Barre syndrome † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Haemorrhage intracranial † 1	3/2432 (0.12%)	3	3/2449 (0.12%)	3
Haemorrhagic transformation stroke † 1	4/2432 (0.16%)	4	0/2449 (0.00%)	0
Headache † 1	2/2432 (0.08%)	2	2/2449 (0.08%)	2
Hemiparesis † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Hypoaesthesia † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Intracranial haematoma † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Ischaemic cerebral infarction † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Ischaemic stroke † 1	82/2432 (3.37%)	83	113/2449 (4.61%)	118
Lacunar infarction † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Metabolic encephalopathy † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Migraine † 1	1/2432 (0.04%)	1	4/2449 (0.16%)	5
Neurological decompensation † 1	1/2432 (0.04%)	1	2/2449 (0.08%)	2
Neurological symptom † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Optic neuritis † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Paraesthesia † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Partial seizures † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Presyncope † 1	1/2432 (0.04%)	1	3/2449 (0.12%)	3
Reversible ischaemic neurological deficit † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Seizure † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Speech disorder † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Subarachnoid haemorrhage † 1	5/2432 (0.21%)	5	1/2449 (0.04%)	1
Syncope † 1	6/2432 (0.25%)	6	4/2449 (0.16%)	4
Transient ischaemic attack † 1	49/2432 (2.01%)	54	55/2449 (2.25%)	62
Tremor † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Psychiatric disorders
Acute psychosis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Acute stress disorder † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Anxiety † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Confusional state † 1	1/2432 (0.04%)	1	3/2449 (0.12%)	3
Conversion disorder † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Delirium † 1	3/2432 (0.12%)	3	0/2449 (0.00%)	0
Depression † 1	0/2432 (0.00%)	0	2/2449 (0.08%)	2
Dysthymic disorder † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Major depression † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Mental status changes † 1	4/2432 (0.16%)	4	1/2449 (0.04%)	1
Somatisation disorder † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Stress † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Suicidal ideation † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Suicide attempt † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Renal and urinary disorders
Calculus ureteric † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Haematuria † 1	3/2432 (0.12%)	3	1/2449 (0.04%)	1
Nephrolithiasis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Nephrotic syndrome † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Renal failure acute † 1	5/2432 (0.21%)	5	3/2449 (0.12%)	3
Renal infarct † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Urinary retention † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Reproductive system and breast disorders
Vaginal haemorrhage † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Asthma † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Chronic obstructive pulmonary disease † 1	2/2432 (0.08%)	2	2/2449 (0.08%)	4
Dyspnoea † 1	2/2432 (0.08%)	2	1/2449 (0.04%)	1
Dyspnoea exertional † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Haemoptysis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Haemothorax † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Hypoxia † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Nasal cavity mass † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Pneumonia aspiration † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Pulmonary embolism † 1	5/2432 (0.21%)	5	2/2449 (0.08%)	2
Respiratory distress † 1	2/2432 (0.08%)	2	4/2449 (0.16%)	4
Respiratory failure † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Skin and subcutaneous tissue disorders
Angioedema † 1	3/2432 (0.12%)	3	1/2449 (0.04%)	1
Erythema † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Pruritus † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Rash † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Urticaria † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Surgical and medical procedures
Arterial repair † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Cardiac pacemaker insertion † 1	2/2432 (0.08%)	2	1/2449 (0.04%)	1
Cardioversion † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Carotid artery stent insertion † 1	0/2432 (0.00%)	0	2/2449 (0.08%)	2
Carotid endarterectomy † 1	7/2432 (0.29%)	7	7/2449 (0.29%)	8
Cholecystectomy † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Coronary revascularisation † 1	1/2432 (0.04%)	1	5/2449 (0.20%)	5
Drug rehabilitation † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Endarterectomy † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Intra-cerebral aneurysm operation † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Nephrectomy † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Rotator cuff repair † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Toe amputation † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Vascular disorders
Accelerated hypertension † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Aortic aneurysm † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Aortic dissection † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Aortic stenosis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Arterial occlusive disease † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Arteriosclerosis † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Arteriovenous fistula † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Deep vein thrombosis † 1	1/2432 (0.04%)	1	6/2449 (0.24%)	6
Haematoma † 1	3/2432 (0.12%)	3	0/2449 (0.00%)	0
Haemorrhage † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Hypertension † 1	3/2432 (0.12%)	3	3/2449 (0.12%)	3
Hypertensive crisis † 1	1/2432 (0.04%)	1	6/2449 (0.24%)	6
Hypertensive emergency † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Hypotension † 1	2/2432 (0.08%)	2	1/2449 (0.04%)	1
Orthostatic hypotension † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Peripheral arterial occlusive disease † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Peripheral vascular disorder † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Subclavian steal syndrome † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
1 Term from vocabulary, MedDRA 15.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Clopidogrel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	89/2432 (3.66%)		84/2449 (3.43%)
Cardiac disorders
Acute myocardial infarction † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Myocardial infarction † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Eye disorders
Conjunctival haemorrhage † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Gastrointestinal disorders
Gastrointestinal haemorrhage † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Haematochezia † 1	4/2432 (0.16%)	4	0/2449 (0.00%)	0
Haemorrhoidal haemorrhage † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Rectal haemorrhage † 1	3/2432 (0.12%)	3	1/2449 (0.04%)	1
Injury, poisoning and procedural complications
Contusion † 1	7/2432 (0.29%)	7	1/2449 (0.04%)	1
Nervous system disorders
Cerebral amyloid angiopathy † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Cerebrovascular accident † 1	3/2432 (0.12%)	3	4/2449 (0.16%)	4
Haemorrhage intracranial † 1	1/2432 (0.04%)	1	1/2449 (0.04%)	1
Haemorrhagic transformation stroke † 1	4/2432 (0.16%)	4	2/2449 (0.08%)	2
Hypoaesthesia † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Ischaemic stroke † 1	13/2432 (0.53%)	14	19/2449 (0.78%)	19
Lacunar infarction † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Subarachnoid haemorrhage † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Transient ischaemic attack † 1	40/2432 (1.64%)	43	42/2449 (1.71%)	46
Renal and urinary disorders
Haematuria † 1	2/2432 (0.08%)	2	2/2449 (0.08%)	2
Reproductive system and breast disorders
Dysfunctional uterine bleeding † 1	0/2432 (0.00%)	0	1/2449 (0.04%)	1
Vaginal haemorrhage † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Epistaxis † 1	4/2432 (0.16%)	4	4/2449 (0.16%)	4
Haemoptysis † 1	1/2432 (0.04%)	1	0/2449 (0.00%)	0
Skin and subcutaneous tissue disorders
Ecchymosis † 1	2/2432 (0.08%)	2	0/2449 (0.00%)	0
Vascular disorders
Haemorrhage † 1	7/2432 (0.29%)	7	1/2449 (0.04%)	1
1 Term from vocabulary, MedDRA 15.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Jordan Elm
• Organization: Medical University of South Carolina
• Phone: 843-876-1605
• EMail: elmj@musc.edu

Publications:

Ovbiagele B. Antiplatelet therapy in management of transient ischemic attack: overview and evidence-based rationale. J Emerg Med. 2008 May;34(4):389-96. doi: 10.1016/j.jemermed.2007.08.056. Epub 2008 Jan 18. Review.

Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2007 Dec;6(12):1063-72. Epub 2007 Nov 13. Review.

Kernan WN, Schindler JL. Rapid intervention for TIA: a new standard emerges. Lancet Neurol. 2007 Nov;6(11):940-1.

Rothwell PM. Transient ischaemic attacks: time to wake up. Heart. 2007 Aug;93(8):893-4.

Streifler JY. Early stroke risk after a transient ischemic attack: can it be minimized? Stroke. 2008 Jun;39(6):1655-6. doi: 10.1161/STROKEAHA.107.510248. Epub 2008 Mar 27.

Dean N, Shuaib A. Transient ischaemic attacks: unstable, treatable, neglected. Lancet. 2007 Oct 20;370(9596):1398-400.

Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. Epub 2007 Oct 10.

Geisler T, Zürn C, Paterok M, Göhring-Frischholz K, Bigalke B, Stellos K, Seizer P, Kraemer BF, Dippon J, May AE, Herdeg C, Gawaz M. Statins do not adversely affect post-interventional residual platelet aggregation and outcomes in patients undergoing coronary stenting treated by dual antiplatelet therapy. Eur Heart J. 2008 Jul;29(13):1635-43. doi: 10.1093/eurheartj/ehn212. Epub 2008 May 24.

Lotfi A, Schweiger MJ, Giugliano GR, Murphy SA, Cannon CP; TIMI 22 Investigators. High-dose atorvastatin does not negatively influence clinical outcomes among clopidogrel treated acute coronary syndrome patients--a Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) analysis. Am Heart J. 2008 May;155(5):954-8. doi: 10.1016/j.ahj.2007.12.009. Epub 2008 Feb 19.

Mitsios JV, Papathanasiou AI, Rodis FI, Elisaf M, Goudevenos JA, Tselepis AD. Atorvastatin does not affect the antiplatelet potency of clopidogrel when it is administered concomitantly for 5 weeks in patients with acute coronary syndromes. Circulation. 2004 Mar 23;109(11):1335-8. Epub 2004 Mar 15.

Riondino S, Petrini N, Donato L, Torromeo C, Tanzilli G, Pulcinelli FM, Barillà F. Effects of rosuvastatin on platelet inhibition by clopidogrel in cardiovascular patients. J Thromb Thrombolysis. 2009 Aug;28(2):151-5. doi: 10.1007/s11239-008-0254-6. Epub 2008 Jul 18.

Saw J, Brennan DM, Steinhubl SR, Bhatt DL, Mak KH, Fox K, Topol EJ; CHARISMA Investigators. Lack of evidence of a clopidogrel-statin interaction in the CHARISMA trial. J Am Coll Cardiol. 2007 Jul 24;50(4):291-5. Epub 2007 Jul 10.

Saw J, Steinhubl SR, Berger PB, Kereiakes DJ, Serebruany VL, Brennan D, Topol EJ; Clopidogrel for the Reduction of Events During Observation Investigators. Lack of adverse clopidogrel-atorvastatin clinical interaction from secondary analysis of a randomized, placebo-controlled clopidogrel trial. Circulation. 2003 Aug 26;108(8):921-4. Epub 2003 Aug 18.

Trenk D, Hochholzer W, Frundi D, Stratz C, Valina CM, Bestehorn HP, Büttner HJ, Neumann FJ. Impact of cytochrome P450 3A4-metabolized statins on the antiplatelet effect of a 600-mg loading dose clopidogrel and on clinical outcome in patients undergoing elective coronary stent placement. Thromb Haemost. 2008 Jan;99(1):174-81. doi: 10.1160/TH07-08-0503.

Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6.

Coutts SB, Eliasziw M, Hill MD, Scott JN, Subramaniam S, Buchan AM, Demchuk AM; VISION study group. An improved scoring system for identifying patients at high early risk of stroke and functional impairment after an acute transient ischemic attack or minor stroke. Int J Stroke. 2008 Feb;3(1):3-10. doi: 10.1111/j.1747-4949.2008.00182.x.

Coutts SB, Simon JE, Eliasziw M, Sohn CH, Hill MD, Barber PA, Palumbo V, Kennedy J, Roy J, Gagnon A, Scott JN, Buchan AM, Demchuk AM. Triaging transient ischemic attack and minor stroke patients using acute magnetic resonance imaging. Ann Neurol. 2005 Jun;57(6):848-54.

Algra A, van Gijn J, Halkes PH, Kappelle LJ, Koudstaal PJ; ESPRIT Study Group. Interpretation of ESPRIT in the FASTER trial. Lancet Neurol. 2008 Mar;7(3):198-9; author reply 199. doi: 10.1016/S1474-4422(08)70030-9.

Lavallée PC, Meseguer E, Abboud H, Cabrejo L, Olivot JM, Simon O, Mazighi M, Nifle C, Niclot P, Lapergue B, Klein IF, Brochet E, Steg PG, Lesèche G, Labreuche J, Touboul PJ, Amarenco P. A transient ischaemic attack clinic with round-the-clock access (SOS-TIA): feasibility and effects. Lancet Neurol. 2007 Nov;6(11):953-60.

Luengo-Fernandez R, Gray AM, Rothwell PM. Effect of urgent treatment for transient ischaemic attack and minor stroke on disability and hospital costs (EXPRESS study): a prospective population-based sequential comparison. Lancet Neurol. 2009 Mar;8(3):235-43. doi: 10.1016/S1474-4422(09)70019-5. Epub 2009 Feb 4.

Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008 Sep 18;359(12):1225-37. doi: 10.1056/NEJMoa0804593. Epub 2008 Aug 27.

Sacco RL, Diener HC, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, Vandermaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51. doi: 10.1056/NEJMoa0805002. Epub 2008 Aug 27.

Brown RD Jr, Petty GW, O'Fallon WM, Wiebers DO, Whisnant JP. Incidence of transient ischemic attack in Rochester, Minnesota, 1985-1989. Stroke. 1998 Oct;29(10):2109-13.

Kissela B, Broderick J, Woo D, Kothari R, Miller R, Khoury J, Brott T, Pancioli A, Jauch E, Gebel J, Shukla R, Alwell K, Tomsick T. Greater Cincinnati/Northern Kentucky Stroke Study: volume of first-ever ischemic stroke among blacks in a population-based study. Stroke. 2001 Jun;32(6):1285-90.

Williams GR, Jiang JG, Matchar DB, Samsa GP. Incidence and occurrence of total (first-ever and recurrent) stroke. Stroke. 1999 Dec;30(12):2523-8.

Kleindorfer D, Panagos P, Pancioli A, Khoury J, Kissela B, Woo D, Schneider A, Alwell K, Jauch E, Miller R, Moomaw C, Shukla R, Broderick JP. Incidence and short-term prognosis of transient ischemic attack in a population-based study. Stroke. 2005 Apr;36(4):720-3. Epub 2005 Feb 24.

Edlow JA, Kim S, Pelletier AJ, Camargo CA Jr. National study on emergency department visits for transient ischemic attack, 1992-2001. Acad Emerg Med. 2006 Jun;13(6):666-72. Epub 2006 Apr 11.

Howard G, Toole JF, Frye-Pierson J, Hinshelwood LC. Factors influencing the survival of 451 transient ischemic attack patients. Stroke. 1987 May-Jun;18(3):552-7.

Shah KH, Kleckner K, Edlow JA. Short-term prognosis of stroke among patients diagnosed in the emergency department with a transient ischemic attack. Ann Emerg Med. 2008 Mar;51(3):316-23. doi: 10.1016/j.annemergmed.2007.08.016. Epub 2007 Oct 25. Review. Erratum in: Ann Emerg Med. 2008 Jun;51(6):774.

Wu CM, McLaughlin K, Lorenzetti DL, Hill MD, Manns BJ, Ghali WA. Early risk of stroke after transient ischemic attack: a systematic review and meta-analysis. Arch Intern Med. 2007 Dec 10;167(22):2417-22. Review.

Gladstone DJ, Kapral MK, Fang J, Laupacis A, Tu JV. Management and outcomes of transient ischemic attacks in Ontario. CMAJ. 2004 Mar 30;170(7):1099-104.

Lisabeth LD, Ireland JK, Risser JM, Brown DL, Smith MA, Garcia NM, Morgenstern LB. Stroke risk after transient ischemic attack in a population-based setting. Stroke. 2004 Aug;35(8):1842-6. Epub 2004 Jun 10.

Eliasziw M, Kennedy J, Hill MD, Buchan AM, Barnett HJ; North American Symptomatic Carotid Endarterectomy Trial Group. Early risk of stroke after a transient ischemic attack in patients with internal carotid artery disease. CMAJ. 2004 Mar 30;170(7):1105-9.

Hill MD, Yiannakoulias N, Jeerakathil T, Tu JV, Svenson LW, Schopflocher DP. The high risk of stroke immediately after transient ischemic attack: a population-based study. Neurology. 2004 Jun 8;62(11):2015-20.

Rothwell PM, Giles MF, Flossmann E, Lovelock CE, Redgrave JN, Warlow CP, Mehta Z. A simple score (ABCD) to identify individuals at high early risk of stroke after transient ischaemic attack. Lancet. 2005 Jul 2-8;366(9479):29-36.

Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke. 2003 Aug;34(8):e138-40. Epub 2003 Jul 10.

Rao SV, Ohman EM, Granger CB, Armstrong PW, Gibler WB, Christenson RH, Hasselblad V, Stebbins A, McNulty S, Newby LK. Prognostic value of isolated troponin elevation across the spectrum of chest pain syndromes. Am J Cardiol. 2003 Apr 15;91(8):936-40.

Whisnant JP, Matsumoto N, Elveback LR. Transient cerebral ischemic attacks in a community. Rochester, Minnesota, 1955 through 1969. Mayo Clin Proc. 1973 Mar;48(3):194-8.

Humphrey PR, Marshall J. Transient ischemic attacks and strokes with recovery prognosis and investigation. Stroke. 1981 Nov-Dec;12(6):765-9.

Putman SF, Adams HP Jr. Usefulness of heparin in initial management of patients with recent transient ischemic attacks. Arch Neurol. 1985 Oct;42(10):960-2.

Biller J, Bruno A, Adams HP Jr, Godersky JC, Loftus CM, Mitchell VL, Banwart KJ, Jones MP. A randomized trial of aspirin or heparin in hospitalized patients with recent transient ischemic attacks. A pilot study. Stroke. 1989 Apr;20(4):441-7.

Dennis M, Bamford J, Sandercock P, Warlow C. Prognosis of transient ischemic attacks in the Oxfordshire Community Stroke Project. Stroke. 1990 Jun;21(6):848-53.

Coull AJ, Lovett JK, Rothwell PM; Oxford Vascular Study. Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications for public education and organisation of services. BMJ. 2004 Feb 7;328(7435):326. Epub 2004 Jan 26.

Daffertshofer M, Mielke O, Pullwitt A, Felsenstein M, Hennerici M. Transient ischemic attacks are more than "ministrokes". Stroke. 2004 Nov;35(11):2453-8. Epub 2004 Oct 14.

Whitehead MA, McManus J, McAlpine C, Langhorne P. Early recurrence of cerebrovascular events after transient ischaemic attack. Stroke. 2005 Jan;36(1):1; author reply 1.

Correia M, Silva MR, Magalhães R, Guimarães L, Silva MC. Transient ischemic attacks in rural and urban northern Portugal: incidence and short-term prognosis. Stroke. 2006 Jan;37(1):50-5. Epub 2005 Dec 1.

Purroy F, Molina CA, Montaner J, Alvarez-Sabín J. Absence of usefulness of ABCD score in the early risk of stroke of transient ischemic attack patients. Stroke. 2007 Mar;38(3):855-6; author reply 857. Epub 2007 Jan 18.

Wang Y, Johnston SC; CHANCE Investigators. Rationale and design of a randomized, double-blind trial comparing the effects of a 3-month clopidogrel-aspirin regimen versus aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event. Am Heart J. 2010 Sep;160(3):380-386.e1. doi: 10.1016/j.ahj.2010.05.017.

Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Meschia JF, Walton RL, Farrugia LP, Ross OA, Elm JJ, Farrant M, Meurer WJ, Lindblad AS, Barsan W, Ching M, Gentile N, Ross M, Nahab F, Easton JD, Kim AS, Zurita KG, Cucchiara B, Johnston SC. Efficacy of Clopidogrel for Prevention of Stroke Based on CYP2C19 Allele Status in the POINT Trial. Stroke. 2020 Jul;51(7):2058-2065. doi: 10.1161/STROKEAHA.119.028713. Epub 2020 Jun 17.

Kamel H, Zhang C, Kleindorfer DO, Levitan EB, Howard VJ, Howard G, Soliman EZ, Johnston SC. Association of Black Race With Early Recurrence After Minor Ischemic Stroke or Transient Ischemic Attack: Secondary Analysis of the POINT Randomized Clinical Trial. JAMA Neurol. 2020 May 1;77(5):601-605. doi: 10.1001/jamaneurol.2020.0010.

Cucchiara B, Elm J, Easton JD, Coutts SB, Willey JZ, Biros MH, Ross MA, Johnston SC. Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial. Stroke. 2020 Mar;51(3):792-799. doi: 10.1161/STROKEAHA.119.027465. Epub 2020 Feb 12.

Farrant M, Easton JD, Adelman EE, Cucchiara BL, Barsan WG, Tillman HJ, Elm JJ, Kim AS, Lindblad AS, Palesch YY, Zhao W, Pauls K, Walsh KB, Martí-Fàbregas J, Bernstein RA, Johnston SC. Assessment of the End Point Adjudication Process on the Results of the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial: A Secondary Analysis. JAMA Netw Open. 2019 Sep 4;2(9):e1910769. doi: 10.1001/jamanetworkopen.2019.10769.

Johnston SC, Elm JJ, Easton JD, Farrant M, Barsan WG, Kim AS, Lindblad AS, Palesch YY, Zurita KG, Albers GW, Cucchiara BL, Kleindorfer DO, Lutsep HL, Pearson C, Sethi P, Vora N; POINT and Neurological Emergencies Treatment Trials Network Investigators. Time Course for Benefit and Risk of Clopidogrel and Aspirin After Acute Transient Ischemic Attack and Minor Ischemic Stroke. Circulation. 2019 Aug 20;140(8):658-664. doi: 10.1161/CIRCULATIONAHA.119.040713. Epub 2019 Jun 26.

Tillman H, Johnston SC, Farrant M, Barsan W, Elm JJ, Kim AS, Lindblad AS, Palesch YY, Easton JD. Risk for Major Hemorrhages in Patients Receiving Clopidogrel and Aspirin Compared With Aspirin Alone After Transient Ischemic Attack or Minor Ischemic Stroke: A Secondary Analysis of the POINT Randomized Clinical Trial. JAMA Neurol. 2019 Jul 1;76(7):774-782. doi: 10.1001/jamaneurol.2019.0932.

Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.

Zhao W, Pauls K. Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system. Clin Trials. 2016 Apr;13(2):223-33. doi: 10.1177/1740774515611889. Epub 2015 Oct 13.

Johnston SC, Easton JD, Farrant M, Barsan W, Battenhouse H, Conwit R, Dillon C, Elm J, Lindblad A, Morgenstern L, Poisson SN, Palesch Y. Platelet-oriented inhibition in new TIA and minor ischemic stroke (POINT) trial: rationale and design. Int J Stroke. 2013 Aug;8(6):479-83. doi: 10.1111/ijs.12129.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00991029
• Other Study ID Numbers: 1U01S062835-01A1
• First Submitted: October 6, 2009
• First Posted: October 7, 2009
• Results First Submitted: October 4, 2018
• Results First Posted: December 4, 2018
• Last Update Posted: December 4, 2018