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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,808
* 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
Duration of DAPT is shortened to 3 months
Aalborg University Hospital
Aalborg, Denmark
RECRUITINGThe Heart Centre, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
RECRUITINGHerlev and Gentofte University Hospital - Gentofte
Hellerup, Denmark
RECRUITINGOdense University Hospital
Odense, Denmark
RECRUITINGZealand University Hospital
Roskilde, Denmark
RECRUITINGAarhus University Hospital
Skejby, Denmark
RECRUITINGBARC type 2-5 bleedings
A composite of type 2-5 non-access site bleeding according to the Bleeding Academic Research Consortium (BARC) scale, ranging from bleedings that require diagnosis, hospitalization, or treatment by a health care professional (BARC type 2) to fatal bleedings (BARC type 5)
Time frame: 1 year
NACE (Net adverse clinical events)
A composite of all-cause mortality, recurrent myocardial infarction, definite stent thrombosis, ischemic stroke, and BARC type 3-5 non-access site bleeding
Time frame: 1 year
MACE (Major adverse cardiovascular events)
A composite of all-cause mortality, recurrent myocardial infarction, definite stent thrombosis and ischemic stroke
Time frame: 3, 6, and 12 months
Bleedings according to BARC and TIMI (Thrombolysis in Myocardial Infarction) defintions
Time frame: 3, 6, and 12 months
All-cause mortality
Time frame: 3, 6, and 12 months
Non-hemorrhagic cardiovascular death
Time frame: 3, 6, and 12 months
Ischemic events
Recurrent MI, definite/probable stent thrombosis, any (non-)target vessel revascularization, coronary artery bypass grafting, ischemic stroke
Time frame: 3, 6, and 12 months
Discontinuation or switch to another antiplatelet drug
Time frame: 3, 6, and 12 months
Pharmacoeconomic endpoint including direct and in-direct medical costs
Direct medical costs (e.g. costs for genotyping, medicinal products, re-hospitalization) and indirect costs (e.g. absence from the workforce).
Time frame: 3, 6, and 12 months
Self-reported quality of life scores
Self-reported quality of life scores according to the EQ-5D-5L questionaries in electronic form
Time frame: 3, 6, and 12 months
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