Non ST Segment Elevation Acute Coronary Syndrome
Conditions
Brief 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.
Interventions
DRUGNo aspirin
No aspirin
DRUGAspirin
75-100 mg once daily
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding endpoint | 12 months | The primary bleeding endpoint at 12 months is major or minor bleeding defined as BARC type 2, 3 or 5 bleeding |
| Ischemic endpoint | 12 months | The primary ischemic endpoint at 12 months is the composite of all-cause mortality, myocardial infarction and stroke |
Countries
Netherlands
Outcome results
None listed