Reducing bleeding risk by not using aspirin in certain heart patients
Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients
This study is testing if heart patients with a specific condition can safely skip aspirin after a procedure to reduce bleeding risks while still preventing heart problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3090 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Trial ID | NCT05125276 on ClinicalTrials.gov |
What this trial studies
This study investigates whether omitting aspirin from the treatment regimen of patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) can lower the incidence of major or minor bleeding while still effectively preventing ischemic events. It is an open-label, multicenter randomized controlled trial that compares the outcomes of patients receiving standard dual antiplatelet therapy, which includes aspirin, against those receiving only a P2Y12-inhibitor after undergoing percutaneous coronary intervention (PCI). The goal is to determine if a single antiplatelet strategy can be safely implemented without compromising patient safety.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with non-ST segment elevation acute coronary syndrome who are scheduled for percutaneous coronary intervention.
Not a fit: Patients with known allergies to aspirin or P2Y12-inhibitors, those requiring dual antiplatelet therapy for other medical reasons, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce bleeding complications for patients undergoing PCI while maintaining effective protection against heart attacks and strokes.
How similar studies have performed: Other studies have explored the effects of single antiplatelet therapy, but this specific approach of omitting aspirin in NSTE-ACS patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam and 1 other locations
- Amsterdam UMC, location AMC — Amsterdam, Netherlands (Recruiting)
- Amsterdam UMC, location VUmc — Amsterdam, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.