NCT05262803RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 15 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2808 (estimated)
- First submitted
- 9 Feb 2022
- Start date
- 17 Jun 2022
- Primary completion date
- Dec 2028
- Lead sponsor
- Rikke Sorensen
- Diseases
- Coronary artery disease
- NCT number
- NCT05262803
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2808
- From 17 Jun 2022 to the primary completion date, Dec 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous stent thrombosis
- Prior intracranial hemorrhage
Other illness
- Contraindications including allergies to ASA or P2Y12 inhibitors
- Resuscitated cardiac arrest with Glasgow Coma Scale \<8 and/or need of intubation
- Active bleeding (BARC ≥2) at randomization
Other
- Indication for oral anticoagulation
- Life expectancy \<1 year
- Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception
- Hypertensive crisis (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg)
- Unable to understand and follow study-related instructions or to comply with study protocol
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| The Heart Centre, Copenhagen University Hospital, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Herlev and Gentofte University Hospital - Gentofte Coordinator of this site? Confirm its status | Hellerup | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Zealand University Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Skejby | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.