NCT05262803 Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction
| NCT ID | NCT05262803 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rikke Sorensen |
| Condition | Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,808 participants |
| Start Date | 2022-06-17 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,808 participants in total. It began in 2022-06-17 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 attacks. Over time, more potent antithrombotic drugs have been introduced like prasugrel and ticagrelor. These drugs have replaced the older drug, clopidogrel, as approximately 30% of patients are low-responders to clopidogrel for genetic reasons. However, the newer drugs introduce a significant risk of serious bleeding. Aim: The aim of this trial is to assess a reduced antithrombotic strategy for high bleeding risk patients with heart attacks to reduce bleeding safely. Hypothesis: Significantly reduced bleeding with a similar preventive effect are expected. Design: The Dan-DAPT trial include high bleeding risk patients with heart attacks from Danish hospitals (Rigshospitalet, Aarhus, Odense, Aalborg, Roskilde, and Gentofte hospital) and randomize them to standard-of-care or shorter and individualized antithrombotic therapy based on responsiveness to clopidogrel after genetic testing.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05262803 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05262803 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05262803 currently recruiting?
Yes, NCT05262803 is actively recruiting participants. Contact the research team at rikke.soerensen@regionh.dk for enrollment information.
Where is the NCT05262803 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Copenhagen, Denmark, Hellerup, Denmark, Odense, Denmark and 2 additional locations.
Who is sponsoring the NCT05262803 clinical trial?
NCT05262803 is sponsored by Rikke Sorensen. The trial plans to enroll 2,808 participants.