Academic Medical Center - University of Amsterdam (AMC-UvA)
J.P.S Henriques
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.
Non ST Segment Elevation Acute Coronary Syndrome
No aspirin
Aspirin
Phase 4
Study Type : | Interventional |
Estimated Enrollment : | 3090 participants |
Masking : | Single |
Primary Purpose : | Treatment |
Official Title : | Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients |
Actual Study Start Date : | May 13, 2022 |
Estimated Primary Completion Date : | July 2025 |
Estimated Study Completion Date : | July 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Interventional arm No aspirin |
Drug: No aspirin |
Active Comparator: Control arm Aspirin (75-100 mg once daily) |
Drug: Aspirin |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Amsterdam UMC, location AMC
Amsterdam, Netherlands,
Recruiting
Amsterdam UMC, location VUmc
Amsterdam, Netherlands,