Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients (LEGACY)
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- STATUS
- Recruiting
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- End date
- May 1, 2025
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- participants needed
- 3090
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- sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Summary
Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy by completely omitting aspirin.
Objective: This study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to ischemic events in patients with non-ST segment elevation acute coronary syndrome.
Study design: Open-label, multicentre randomized controlled trial.
Study population: Adult patients presenting with non-ST segment elevation acute coronary syndrome undergoing percutaneous coronary intervention.
Intervention: In the intervention group aspirin will be completely omitted from the antiplatelet regimen in the 12 months following PCI.
Main study endpoints: The primary bleeding endpoint is major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding at 12 months. The primary ischemic endpoint is ischemic events defined as the composite of all-cause death, myocardial infarction and stroke at 12 months.
Details
| Condition | Non ST Segment Elevation Acute Coronary Syndrome |
|---|---|
| Treatment | Aspirin, No aspirin |
| Clinical Study Identifier | NCT05125276 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Last Modified on | 1 July 2022 |
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