NCT05262803

Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,808 (estimated)
• Sponsor: Rikke Sorensen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-17
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2022-03-02
• Last updated: 2024-03-15

Locations

6 sites across 1 country: Denmark