LEGACY: Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients
Study Details
Study Description
Brief 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 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 net clinical adverse events and 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 planned for 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 parameters/endpoints: The primary net adverse clinical endpoint is defined as the composite of all-cause death, myocardial infarction, stroke and Bleeding Academic Research Consortium type 3 or 5 bleeding at 12 months. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Interventional arm No aspirin | Drug: No aspirin No aspirin |
| Active Comparator: Control arm Aspirin (75-100 mg once daily) | Drug: Aspirin 75-100 mg once daily |
Outcome Measures
Primary Outcome Measures
- Net adverse clinical endpoint (NACE) [12 months]
The primary net adverse clinical endpoint at 12 months is the composite of all-cause mortality, myocardial infarction, stroke and major bleeding defined as Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding
- Bleeding endpoint [12 months]
The primary bleeding endpoint at 12 months is major or minor bleeding defined as BARC type 2, 3 or 5 bleeding
- Ischemic endpoint [12 months]
The primary ischemic endpoint at 12 months is the composite of all-cause mortality, myocardial infarction and stroke
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patients presenting with NSTE-ACS planned for PCI
-
Written informed consent
Exclusion Criteria:
-
Known allergy or contraindication for aspirin or P2Y12-inhibitors
-
Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)
-
Overwriting indication for DAPT (e.g. recent PCI or ACS)
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Planned surgical intervention within 12 months of revascularization
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Pregnant or breastfeeding women at time of enrolment
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Participation in another trial with an investigational drug or device (i.e. stent)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL79129.018.21
