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

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ClinicalTrials.gov Identifier: NCT00991029
Recruitment Status : Terminated (The trial was halted by the DSMB.)
First Posted : October 7, 2009
Results First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
The EMMES Corporation
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

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clopidogrel Placebo
Hide 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
Arm/Group Title Clopidogrel Placebo Total
Hide 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
Hide 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).
1.Primary Outcome
Title Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes
Hide Description Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes
Time Frame Up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide Description Primary safety outcome: Number of Participants with major hemorrhage
Time Frame Up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide Description Secondary efficacy outcome:Number of participants with Ischemic stroke
Time Frame Up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide Description Secondary efficacy outcome: Number of participants with Myocardial infarction
Time Frame Up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide Description Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes
Time Frame Up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide Description Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke
Time Frame Up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide Description Other safety outcome: Number of participants with Hemorrhagic stroke
Time Frame up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide Description Other safety outcome: Number of participants with Symptomatic intracerebral hemorrhage
Time Frame up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide Description Other safety outcome: Number of participants with other symptomatic intracranial hemorrhage
Time Frame up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide Description Other safety outcome: Number of Participants with Major hemorrhage other than intracranial hemorrhage
Time Frame up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide Description Other safety outcome:Number of Participants with Minor hemorrhage
Time Frame up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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
Hide Description Other safety outcome: Number of Participants with Death from any cause
Time Frame up to 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Placebo
Hide 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%
Show Statistical Analysis 1 Hide 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]
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
Hide 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%)    
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00991029     History of Changes
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