The Dan-DAPT trial
- Conditions
- Myocardial infarctionTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2022-500125-32-00
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2700
1.MI caused by atherothrombotic CAD (Type 1 MI) according to The Fourth Universal Definition of MI”, which has been treated with PCI with contemporary drug-eluting stents. This definition of type 1 MI requires the detection of a rise and/or fall of cardiac troponin values with at least one value >99th percentile and at least one of the following criteria assessed by the treating physician: •symptoms indicating acute myocardial ischemia •new ischemic changes on the electrocardiogram •development of pathological Q-waves •imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology •visible coronary thrombus by angiography 2.PRECISE-DAPT score =25 3.Age =18 years
1.Contraindications including allergies to ASA or P2Y12 inhibitors 2.Indication for oral anticoagulation 3.Previous stent thrombosis 4.Life expectancy <1 year 5.Resuscitated cardiac arrest with Glasgow Coma Scale <8 and/or need of intubation 6.Prior intracranial hemorrhage 7.Active bleeding (BARC =2) at randomization 8.Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception 9.Hypertensive crisis (systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg) 10.Unable to understand and follow study-related instructions or to comply with study protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method