Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients (LEGACY)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase

Enrolling

Phase 4

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Treatments

Drug: Aspirin

Drug: No aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT05125276

NL79129.018.21

Details and patient eligibility

About

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.

Enrollment

3,090 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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