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NCT Number: NCT05262803

Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Contraindications including allergies to ASA or P2Y12 inhibitors
  • Indication for oral anticoagulation
  • Previous stent thrombosis
  • Life expectancy <1 year
  • Resuscitated cardiac arrest with Glasgow Coma Scale <8 and/or need of intubation
  • Prior intracranial hemorrhage
  • Active bleeding (BARC ≥2) at randomization
  • 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

Treatment and study plan

CYP2C19*2/*3

Genetic
  • 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

Shorter DAPT duration

Other

Duration of DAPT is shortened to 3 months

Primary outcomes

  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

Secondary outcomes

  1. 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

  2. Bleedings according to BARC and TIMI (Thrombolysis in Myocardial Infarction) defintions

    Time frame: 3, 6, and 12 months

  3. All-cause mortality

    Time frame: 3, 6, and 12 months

  4. Non-hemorrhagic cardiovascular death

    Time frame: 3, 6, and 12 months

  5. 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

  6. Discontinuation or switch to another antiplatelet drug

    Time frame: 3, 6, and 12 months

  7. 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).

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mia R Jacobsen, MD

CONTACT

[email protected]

35459897 ext. +45

Rikke Sorensen, MD, Ph.D.

CONTACT

[email protected]

35456851 ext. +45

Sponsors and collaborators

Lead sponsor

Rikke Sorensen

Other

Registry information

Official study title

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

Acronym: Dan-DAPT

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 2, 2022
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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