NCT05125276

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,090 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non ST Segment Elevation Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	No aspirin	No aspirin
DRUG	Aspirin	75-100 mg once daily

Timeline

• Start date: 2022-05-13
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2021-11-18
• Last updated: 2023-07-19

Locations

2 sites across 1 country: Netherlands