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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction (NCT05262803) is a Phase 4 interventional studying Myocardial Infarction, sponsored by Rikke Sorensen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 2,808 participants makes this one of the larger Myocardial Infarction trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Aalborg University Hospital
Aalborg, Denmark
The Heart Centre, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Herlev and Gentofte University Hospital - Gentofte
Hellerup, Denmark
Odense University Hospital
Odense, Denmark
Zealand University Hospital
Roskilde, Denmark
Aarhus University Hospital
Skejby, Denmark

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05262803), the sponsor (Rikke Sorensen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05262803 clinical trial studying?

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… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05262803?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05262803?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05262803. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05262803. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.