Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (ASPIRE)
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- STATUS
- Recruiting
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- End date
- Apr 10, 2024
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- participants needed
- 700
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- sponsor
- Yale University
Summary
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.
Description
ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.
Details
| Condition | Intracerebral Hemorrhage, Atrial Fibrillation |
|---|---|
| Treatment | Aspirin, Apixaban |
| Clinical Study Identifier | NCT03907046 |
| Sponsor | Yale University |
| Last Modified on | 4 October 2022 |
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