Status:
RECRUITING
Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction
Lead Sponsor:
Rikke Sorensen
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Rationale: Heart attacks are a major cause of death and result from coronary blood clots that require acute coronary intervention and antithrombotic drugs to restore blood flow and prevent new heart a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
2808 Patients enrolled
Trial Details
Trial ID
NCT05262803
Start Date
June 17 2022
End Date
December 1 2028
Last Update
March 15 2024
Active Locations (6)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000
2
The Heart Centre, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
3
Herlev and Gentofte University Hospital - Gentofte
Hellerup, Denmark, 2900
4
Odense University Hospital
Odense, Denmark, 5000