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Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction Treated With Percutaneous Coronary Intervention - The Dan-DAPT Trial

Who is this study for? Patients with Myocardial Infarction
What treatments are being studied? CYP2C19*2/*3
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Genetic, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
The Heart Centre, Copenhagen University Hospital, Rigshospitalet
RECRUITING
Copenhagen
Herlev and Gentofte University Hospital - Gentofte
RECRUITING
Hellerup
Odense University Hospital
RECRUITING
Odense
Zealand University Hospital
RECRUITING
Roskilde
Aarhus University Hospital
RECRUITING
Skejby
Contact Information
Primary
Rikke Sorensen, MD, Ph.D.
rikke.soerensen@regionh.dk
35456851
Backup
Mia R Jacobsen, MD
mia.ravn.jacobsen@regionh.dk
35459897
Time Frame
Start Date: 2022-06-17
Estimated Completion Date: 2028-12
Participants
Target number of participants: 2808
Treatments
No_intervention: Standard-of-care DAPT
Dual antiplatelet therapy (DAPT) with acetylsalicylic acid (ASA) and prasugrel or ticagrelor for 6 months followed by ASA monotherapy.
Experimental: Genotype-guided DAPT
DAPT according to CYP2C19\*2/\*3-genotyping for 6 months followed by ASA monotherapy.
Experimental: Shorter genotype-guided DAPT
DAPT according to CYP2C19\*2/\*3-genotyping for 3 months followed by ASA monotherapy.
Sponsors
Leads: Rikke Sorensen

This content was sourced from clinicaltrials.gov

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