Actively Recruiting
Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction
Led by Rikke Sorensen · Updated on 2024-03-15
2808
Participants Needed
6
Research Sites
337 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Heart attack caused by atherothrombotic coronary artery disease (Type 1 myocardial infarction) treated with percutaneous coronary intervention using modern drug-eluting stents
- PRECISE-DAPT bleeding risk score of 25 or higher
- Age 18 years or older
You will not qualify if you...
- Allergy or contraindication to aspirin or P2Y12 inhibitors
- Need for oral anticoagulation treatment
- Previous stent thrombosis
- Life expectancy less than 1 year
- Resuscitated cardiac arrest with severe coma (Glasgow Coma Scale less than 8) or need for intubation
- Prior intracranial bleeding
- Active bleeding at randomization (BARC grade 2 or higher)
- Women who are pregnant, recently gave birth (within 90 days), breastfeeding, or fertile without contraception
- Hypertensive crisis (systolic blood pressure over 180 mmHg and/or diastolic over 120 mmHg)
- Unable to understand or follow study instructions or comply with protocol
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
2
The Heart Centre, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Herlev and Gentofte University Hospital - Gentofte
Hellerup, Denmark, 2900
Actively Recruiting
4
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
5
Zealand University Hospital
Roskilde, Denmark, 4000
Actively Recruiting
6
Aarhus University Hospital
Skejby, Denmark, 8200
Actively Recruiting
Research Team
R
Rikke Sorensen, MD, Ph.D.
CONTACT
M
Mia R Jacobsen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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