Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients
Status:
Not yet recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)