Reduced blood-thinning strategy for heart attack patients at high risk of bleeding
Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction Treated With Percutaneous Coronary Intervention - The Dan-DAPT Trial
PHASE4 · Rigshospitalet, Denmark · NCT05262803
This study is testing if a shorter course of blood-thinning medication can help heart attack patients who are at high risk of bleeding, while still protecting them from future heart problems.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2808 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 6 sites (Aalborg and 5 other locations) |
| Trial ID | NCT05262803 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate a reduced antithrombotic strategy for patients with myocardial infarction who are at high risk of bleeding. It focuses on patients treated with percutaneous coronary intervention and assesses the effectiveness of a shorter duration of dual antiplatelet therapy compared to standard care. The study will involve multiple hospitals in Denmark and will utilize genetic testing to tailor treatment. The hypothesis is that this approach will lead to significantly reduced bleeding risks while maintaining similar protective effects against further heart attacks.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced a type 1 myocardial infarction and have a high PRECISE-DAPT score.
Not a fit: Patients with contraindications to antithrombotic medications or those requiring oral anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer treatment option for heart attack patients who are at high risk of bleeding.
How similar studies have performed: Other studies have shown promise in reducing bleeding risks with tailored antithrombotic strategies, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg and 5 other locations
- Aalborg University Hospital — Aalborg, Denmark (RECRUITING)
- The Heart Centre, Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- Herlev and Gentofte University Hospital - Gentofte — Hellerup, Denmark (RECRUITING)
- Odense University Hospital — Odense, Denmark (RECRUITING)
- Zealand University Hospital — Roskilde, Denmark (RECRUITING)
- Aarhus University Hospital — Skejby, Denmark (RECRUITING)
Study contacts
- Study coordinator: Rikke Sorensen, MD, Ph.D.
- Email: rikke.soerensen@regionh.dk
- Phone: 35456851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myocardial Infarction, High bleeding risk, CYP2C19 genotyping, Dual antiplatelet therapy, Percutaneous coronary intervention