ess Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients
Phase 4
Recruiting
- Conditions
- 'acute coronary syndrome''heart attack'10011082
- Registration Number
- NL-OMON54035
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3090
Inclusion Criteria
- Adult patients presenting with NSTE-ACS undergoing PCI
- Written informed consent
Exclusion Criteria
- Known allergy or contraindication for aspirin or P2Y12-inhibitors
- Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)
- Overwriting indication for DAPT (e.g. recent PCI or ACS)
- Planned surgical intervention within 12 months of revascularization
- Pregnant or breastfeeding women at time of enrolment
- Participation in another trial with an investigational drug or device (i.e.
stent)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary bleeding endpoint at 12 months is:<br /><br>- Major or minor bleeding defined as Bleeding Academic Research Consortium<br /><br>(BARC) type 2, 3 or 5 bleeding<br /><br><br /><br>The primary ischemic endpoint at 12 months is the composite of:<br /><br>- All-cause mortality<br /><br>- Myocardial infarction (according to the 4th universal definition of MI)<br /><br>- Stroke </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Primary bleeding and ischemic endpoints at 1, 3 and 6 month(s)<br /><br>- Individual components of the primary endpoints at 1, 3, 6 and 12 month(s)<br /><br>- Net adverse clinical events at 1, 3, 6 and 12 month(s) defined as all-cause<br /><br>mortality, MI, stroke and major bleeding (BARC type 3 or 5 bleeding)<br /><br>- Academic Research Consortium (ARC) defined definite or probable stent<br /><br>thrombosis at 1, 3, 6 and 12 month(s)<br /><br>- Repeat revascularization at 1, 3, 6 and 12 month(s) including periprocedural<br /><br>medication during repeat revascularization<br /><br>- Modifications to aspirin or P2Y12-inhibitor regimen at 1, 3, 6 and 12<br /><br>month(s)</p><br>