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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non ST Segment Elevation Acute Coronary Syndrome

Intervention / Treatment
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* Drug: No aspirin
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional arm<br>No aspirin | Drug: No aspirin<br>* No aspirin<br>|
| Active Comparator: Control arm<br>Aspirin (75-100 mg once daily) | Drug: Aspirin<br>* 75-100 mg once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding endpoint | The primary bleeding endpoint at 12 months is major or minor bleeding defined as BARC type 2, 3 or 5 bleeding | 12 months | 
| Ischemic endpoint | The primary ischemic endpoint at 12 months is the composite of all-cause mortality, myocardial infarction and stroke | 12 months |