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 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.
| 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
- 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:
-
Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)
-
Successful PCI (according to the treating physician)
Exclusion Criteria:
-
Known allergy or contraindication for aspirin or all commercially available P2Y12-inhibitors (i.e. ticagrelor, prasugrel and clopidogrel)
-
Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)
-
Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS)
-
Planned surgical intervention within 12 months of PCI
-
Pregnant or breastfeeding women at time of enrolment
-
Participation in another trial with an investigational drug or device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Amsterdam UMC, location AMC | Amsterdam | Netherlands | ||
| 2 | Amsterdam UMC, location VUmc | Amsterdam | Netherlands |
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