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RECRUITING
NCT05262803
PHASE4

Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction

Sponsor: Rikke Sorensen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2808

Start Date

2022-06-17

Completion Date

2028-12

Last Updated

2024-03-15

Healthy Volunteers

No

Interventions

GENETIC

CYP2C19*2/*3

* Non-carriers of CYP2C19\*2/\*3 loss-of-function alleles: DAPT with clopidogrel and ASA * Carriers of CYP2C19\*2/\*3 loss-of-function alleles: DAPT with prasugrel (or ticagrelor) and ASA

OTHER

Shorter DAPT duration

Duration of DAPT is shortened to 3 months

Locations (6)

Aalborg University Hospital

Aalborg, Denmark

The Heart Centre, Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Herlev and Gentofte University Hospital - Gentofte

Hellerup, Denmark

Odense University Hospital

Odense, Denmark

Zealand University Hospital

Roskilde, Denmark

Aarhus University Hospital

Skejby, Denmark