Reduced blood-thinning strategy for heart attack patients at high risk of bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.