CTIS2022-500125-32-00
Recruiting
Phase 1
Reduced antithrombotic strategy for high bleeding risk patients with myocardial infarction treated with percutaneous coronary intervention - The Dan-DAPT trial - 2022-500125-32-00
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Myocardial infarction
- Sponsor
- Rigshospitalet
- Enrollment
- 2700
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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