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Platelet-oriented inhibition in new TIA and minor ischemic stroke (POINT) trial: rationale and design
S Claiborne Johnston1, J Donald Easton, Mary Farrant
1Department of Neurology, University of California, San Francisco, CA, USA. clay.johnston@ucsfmedctr.org
Insights
Early treatment with clopidogrel plus aspirin after transient ischemic attack or minor stroke may reduce vascular events. This study compared this combination therapy against aspirin alone to assess efficacy and safety in high-risk patients.
Area of Science:
- Neurology
- Cardiology
- Clinical Trials
Background:
- Vascular outcomes like ischemic stroke affect 10-20% of patients within three months of a transient ischemic attack (TIA) or minor ischemic stroke.
- The initial hours and days post-event represent the highest risk period for these disabling outcomes.
- Aspirin is the standard antithrombotic treatment for patients following a TIA or minor ischemic stroke.
Purpose of the Study:
- To evaluate if clopidogrel combined with aspirin, administered within 12 hours of symptom onset, is more effective than aspirin alone in preventing major ischemic vascular events at 90 days.
- To assess the safety profile of acute clopidogrel plus aspirin therapy compared to aspirin monotherapy in high-risk patients.
Main Methods:
- A prospective, randomized, double-blind, multicenter trial (POINT) involving patients with TIA or minor ischemic stroke.
- Participants were randomized to receive either clopidogrel (600 mg loading dose, then 75 mg/day) or a placebo.
- All participants received open-label aspirin (50-325 mg/day), with a recommended daily dose of 162 mg for five days followed by 81 mg.
Main Results:
- The primary efficacy endpoint was the composite of new ischemic vascular events (ischemic stroke, myocardial infarction, ischemic vascular death) within 90 days.
- The primary safety endpoint focused on major hemorrhage, including symptomatic intracranial hemorrhage.
Conclusions:
- Aspirin is a common antithrombotic used post-stroke or TIA to lower subsequent stroke risk.
- This trial aimed to determine the comparative effectiveness and safety of acute clopidogrel plus aspirin versus aspirin alone for preventing early vascular events.
Background:
Ischemic stroke and other vascular outcomes occur in 10-20% of patients in the three-months following a transient ischemic attack or minor ischemic stroke, and many are disabling. The highest risk period for these outcomes is the early hours and days immediately following the ischemic event. Aspirin is the most common antithrombotic treatment used for these patients.
Aim:
The aim of POINT is to determine whether clopidogrel plus aspirin taken <12 h after transient ischemic attack or minor ischemic stroke symptom onset is more effective in preventing major ischemic vascular events at 90 days in the high-risk, and acceptably safe, compared with aspirin alone.
Design:
POINT is a prospective, randomized, double-blind, multicenter trial in patients with transient ischemic attack or minor ischemic stroke. Subjects are randomized to clopidogrel (600 mg loading dose followed by 75 mg/day) or matching placebo, and all will receive open-label aspirin 50-325 mg/day, with a dose of 162 mg daily for five-days followed by 81 mg daily strongly recommended.
Study Outcomes:
The primary efficacy outcome is the composite of new ischemic vascular events - ischemic stroke, myocardial infarction, or ischemic vascular death - by 90 days. The primary safety outcome is major hemorrhage, which includes symptomatic intracranial hemorrhage.
Discussion:
Aspirin is the most common antithrombotic given to patients with a stroke or transient ischemic attack, as it reduces the risk of subsequent stroke. This trial expects to determine whether more aggressive antithrombotic therapy with clopidogrel plus aspirin, initiated acutely, is more effective than aspirin alone.
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