Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction (Dan-DAPT)
Myocardial Infarction
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring High bleeding risk, CYP2C19 genotyping, Dual antiplatelet therapy, Percutaneous coronary intervention
Eligibility Criteria
Inclusion Criteria:
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
- PRECISE-DAPT score ≥25
- Age ≥18 years
Exclusion Criteria:
- Contraindications including allergies to ASA or P2Y12 inhibitors
- Indication for oral anticoagulation
- Previous stent thrombosis
- Life expectancy <1 year
- Resuscitated cardiac arrest with Glasgow Coma Scale <8 and/or need of intubation
- Prior intracranial hemorrhage
- Active bleeding (BARC ≥2) at randomization
- Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception
- Hypertensive crisis (systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg)
- Unable to understand and follow study-related instructions or to comply with study protocol
Sites / Locations
- Aalborg University Hospital
- The Heart Centre, Copenhagen University Hospital, RigshospitaletRecruiting
- Herlev and Gentofte University Hospital - Gentofte
- Odense University Hospital
- Zealand University Hospital
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
Standard-of-care DAPT
Genotype-guided DAPT
Shorter genotype-guided DAPT
Dual antiplatelet therapy (DAPT) with acetylsalicylic acid (ASA) and prasugrel or ticagrelor for 6 months followed by ASA monotherapy.
DAPT according to CYP2C19*2/*3-genotyping for 6 months followed by ASA monotherapy.
DAPT according to CYP2C19*2/*3-genotyping for 3 months followed by ASA monotherapy.