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

March 12, 2024 updated by: Rikke Sorensen

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2808

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Aalborg University Hospital
        • Contact:
          • Phillip Freeman, BSc, MBBS, MRCP, Ph.D.
      • Copenhagen, Denmark, 2100
        • Recruiting
        • The Heart Centre, Copenhagen University Hospital, Rigshospitalet
        • Contact:
        • 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
      • Hellerup, Denmark, 2900
        • Recruiting
        • Herlev and Gentofte University Hospital - Gentofte
        • Contact:
          • Mette G Charlot, MD, Ph.D.
      • Odense, Denmark, 5000
        • Recruiting
        • Odense University Hospital
        • Contact:
          • Karsten T Veien, MD, DMSc
      • Roskilde, Denmark, 4000
        • Recruiting
        • Zealand University Hospital
        • Contact:
          • Henning S Kelbaek, MD, DMSc
      • Skejby, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleedings according to BARC and TIMI (Thrombolysis in Myocardial Infarction) defintions
Time Frame: 3, 6, and 12 months
3, 6, and 12 months
All-cause mortality
Time Frame: 3, 6, and 12 months
3, 6, and 12 months
Non-hemorrhagic cardiovascular death
Time Frame: 3, 6, and 12 months
3, 6, and 12 months
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
3, 6, and 12 months
Discontinuation or switch to another antiplatelet drug
Time Frame: 3, 6, and 12 months
3, 6, and 12 months
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).
3, 6, and 12 months
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
3, 6, and 12 months
MACE (Major adverse cardiovascular events)
Time Frame: 3, 6, and 12 months
A composite of all-cause mortality, recurrent myocardial infarction, definite stent thrombosis and ischemic stroke
3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rikke Sorensen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2022

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-500125-32-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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