What is the optimal antithrombotic strategy in patients presenting with acute coronary syndrome having atrial fibrillation with indication for anticoagulants?
Phase 4
Withdrawn
- Conditions
- heart attackmyocardial infarction100644771001108210014523
- Registration Number
- NL-OMON49131
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 2500
Inclusion Criteria
Over 18 years of age
Acute coronary syndrome with elevated cardiac enzymes
Atrial fibrillation with long-term indication for oral anticoagulation
Exclusion Criteria
Severe bleeding in past 3 months
Known coagulopathy
Contra-indications for intended medication (NOAC, P2Y12-remmer, ASA)
eGFR < 15 min/kg/1.73m2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy endpoint: composed endpoint of all-cause death, MI, stroke,<br /><br>systemic embolism, stent thrombosis.<br /><br>Primary safety endpoint: ISTH major + clinically relevant non-major bleeding.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints: separate components of primary endpoints, net clinical<br /><br>benefit, quality of life.</p><br>