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Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction (Dan-DAPT)

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ClinicalTrials.gov Identifier: NCT05262803
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Rikke Sorensen, Rigshospitalet, Denmark

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Genetic: CYP2C19*2/*3 Other: Shorter DAPT duration Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2808 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction Treated With Percutaneous Coronary Intervention - The Dan-DAPT Trial
Actual Study Start Date : June 17, 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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
Experimental: Shorter genotype-guided DAPT
DAPT according to CYP2C19*2/*3-genotyping for 3 months followed by ASA monotherapy.
 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


Outcome Measures
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Primary Outcome Measures :
  1. BARC type 2-5 bleedings [ Time Frame: 1 year ]
    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)

  2. NACE (Net adverse clinical events) [ Time Frame: 1 year ]
    A composite of all-cause mortality, recurrent myocardial infarction, definite stent thrombosis, ischemic stroke, and BARC type 3-5 non-access site bleeding

  3. MACE (Major cardiovascular events) [ Time Frame: 1 year ]
    A composite of all-cause mortality, recurrent myocardial infarction (MI), definite stent thrombosis, and ischemic stroke


Secondary Outcome Measures :
  1. Bleedings according to BARC and TIMI (Thrombolysis in Myocardial Infarction) defintions [ Time Frame: 3, 6, and 12 months ]
  2. All-cause mortality [ Time Frame: 3, 6, and 12 months ]
  3. Non-hemorrhagic cardiovascular death [ Time Frame: 3, 6, and 12 months ]
  4. Ischemic events [ Time Frame: 3, 6, and 12 months ]
    Recurrent MI, definite/probable stent thrombosis, any (non-)target vessel revascularization, coronary artery bypass grafting, ischemic stroke

  5. Discontinuation or switch to another antiplatelet drug [ Time Frame: 3, 6, and 12 months ]
  6. Pharmacoeconomic endpoint including direct and in-direct medical costs [ Time Frame: 3, 6, and 12 months ]
    Direct medical costs (e.g. costs for genotyping, medicinal products, re-hospitalization) and indirect costs (e.g. absence from the workforce).

  7. Self-reported quality of life scores [ Time Frame: 3, 6, and 12 months ]
    Self-reported quality of life scores according to the EQ-5D-5L questionaries in electronic form


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. PRECISE-DAPT score ≥25
  3. Age ≥18 years

Exclusion Criteria:

  1. Contraindications including allergies to ASA or P2Y12 inhibitors
  2. Indication for oral anticoagulation
  3. Previous stent thrombosis
  4. Life expectancy <1 year
  5. Resuscitated cardiac arrest with Glasgow Coma Scale <8 and/or need of intubation
  6. Prior intracranial hemorrhage
  7. Active bleeding (BARC ≥2) at randomization
  8. Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception
  9. Hypertensive crisis (systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg)
  10. Unable to understand and follow study-related instructions or to comply with study protocol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05262803


Contacts
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Contact: Rikke Sorensen, MD, Ph.D. 35456851 ext +45 rikke.soerensen@regionh.dk
Contact: Mia R Jacobsen, MD 35459897 ext +45 mia.ravn.jacobsen@regionh.dk

Locations
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Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark, 9000
Contact: Phillip Freeman, BSc, MBBS, MRCP, Ph.D.         
The Heart Centre, Copenhagen University Hospital, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Rikke Sorensen, MD, Ph.D.    35456851 ext +45    rikke.soerensen@regionh.dk   
Principal Investigator: Rikke Sorensen, MD, Ph.D.         
Sub-Investigator: Mia R Jacobsen, MD         
Sub-Investigator: Jabbari Jabbari, MD, Ph.D.         
Sub-Investigator: Thomas Engstrom, Prof., MD, Ph.D., DMSc         
Herlev and Gentofte University Hospital - Gentofte Not yet recruiting
Hellerup, Denmark, 2900
Contact: Mette G Charlot, MD, Ph.D.         
Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Contact: Karsten T Veien, MD, DMSc         
Zealand University Hospital Not yet recruiting
Roskilde, Denmark, 4000
Contact: Henning S Kelbaek, MD, DMSc         
Aarhus University Hospital Not yet recruiting
Skejby, Denmark, 8200
Contact: Erik L Grove, Assoc.prof., MD, Ph.D.         
Principal Investigator: Erik L Grove, Assoc. prof., MD, Ph.D         
Sub-Investigator: Michael Maeng, Assoc. prof., MD         
Sponsors and Collaborators
Rikke Sorensen
More Information
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Publications:

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Responsible Party: Rikke Sorensen, MD, Ph.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT05262803    
Other Study ID Numbers: 2022-500125-32-00
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Rikke Sorensen, Rigshospitalet, Denmark:
High bleeding risk
CYP2C19 genotyping
Dual antiplatelet therapy
Percutaneous coronary intervention
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Hemorrhage
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases