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
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Continuous
[1] Median (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 2432 participants | 2449 participants | 4881 participants | |
65.0
(55.0 to 74.0)
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65.0
(56.0 to 74.0)
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65.0
(55.0 to 74.0)
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[1]
Measure Description: Age at time of randomization
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2432 participants | 2449 participants | 4881 participants | |
Female |
1097 45.1%
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1098 44.8%
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2195 45.0%
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Male |
1335 54.9%
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1351 55.2%
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2686 55.0%
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Ethnicity (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2432 participants | 2449 participants | 4881 participants | |
Hispanic or Latino |
144 5.9%
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146 6.0%
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290 5.9%
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Not Hispanic or Latino |
2176 89.5%
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2182 89.1%
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4358 89.3%
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Unknown or Not Reported |
112 4.6%
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121 4.9%
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233 4.8%
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[1]
Measure Description: Race or ethnic group was determined by the investigator. Hispanic ethnic group was assessed only in patients in the United States.
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2432 participants | 2449 participants | 4881 participants | |
American Indian or Alaska Native |
7 0.3%
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16 0.7%
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23 0.5%
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Asian |
77 3.2%
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67 2.7%
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144 3.0%
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Native Hawaiian or Other Pacific Islander |
10 0.4%
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5 0.2%
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15 0.3%
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Black or African American |
473 19.4%
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493 20.1%
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966 19.8%
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White |
1774 72.9%
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1781 72.7%
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3555 72.8%
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More than one race |
4 0.2%
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5 0.2%
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9 0.2%
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Unknown or Not Reported |
87 3.6%
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82 3.3%
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169 3.5%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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New Zealand | Number Analyzed | 2432 participants | 2449 participants | 4881 participants |
3 0.1%
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4 0.2%
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7 0.1%
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Canada | Number Analyzed | 2432 participants | 2449 participants | 4881 participants |
121 5.0%
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119 4.9%
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240 4.9%
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United States | Number Analyzed | 2432 participants | 2449 participants | 4881 participants |
2014 82.8%
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2029 82.9%
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4043 82.8%
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Finland | Number Analyzed | 2432 participants | 2449 participants | 4881 participants |
25 1.0%
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25 1.0%
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50 1.0%
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Mexico | Number Analyzed | 2432 participants | 2449 participants | 4881 participants |
5 0.2%
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4 0.2%
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9 0.2%
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United Kingdom | Number Analyzed | 2432 participants | 2449 participants | 4881 participants |
33 1.4%
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38 1.6%
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71 1.5%
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Australia | Number Analyzed | 2432 participants | 2449 participants | 4881 participants |
53 2.2%
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51 2.1%
|
104 2.1%
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France | Number Analyzed | 2432 participants | 2449 participants | 4881 participants |
51 2.1%
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47 1.9%
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98 2.0%
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Germany | Number Analyzed | 2432 participants | 2449 participants | 4881 participants |
8 0.3%
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10 0.4%
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18 0.4%
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Spain | Number Analyzed | 2432 participants | 2449 participants | 4881 participants |
119 4.9%
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122 5.0%
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241 4.9%
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Qualifying Event
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2432 participants | 2449 participants | 4881 participants | |
TIA |
1056 43.4%
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1052 43.0%
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2108 43.2%
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Ischemic Stroke |
1376 56.6%
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1397 57.0%
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2773 56.8%
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[1]
Measure Description: TIA or Ischemic Stroke
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Qualifying Neurologic Score
[1] [2] Median (Inter-Quartile Range) Unit of measure: Units on a scale |
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ABCD2 | Number Analyzed | 1055 participants | 1049 participants | 2104 participants |
5.0
(4.0 to 6.0)
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5.0
(4.0 to 5.0)
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5.0
(4.0 to 6.0)
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National Institutes of Health Stroke Scale | Number Analyzed | 1365 participants | 1385 participants | 2750 participants |
2.0
(1.0 to 2.0)
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2.0
(1.0 to 2.0)
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2.0
(1.0 to 2.0)
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[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).
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Name/Title: | Dr. Jordan Elm |
Organization: | Medical University of South Carolina |
Phone: | 843-876-1605 |
EMail: | elmj@musc.edu |
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 |