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Myocardial Infarction (MI)HERO-AF-AMINCT07583784

Abbreviated Antithrombotic Therapy After PCI in Patients With AF and AMI

A study testing DAT (DOAC+clopidogrel) and DOAC monotherapy in people with Myocardial Infarction (MI) and ST-Segment Elevation Myocardial Infarction(STEMI), run by Chonnam National University Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of the study is to compare clinical outcomes between direct oral anticoagulant (DOAC) monotherapy versus dual antithrombotic therapy (DOAC plus clopidogrel) in patients with atrial fibrillation and acute myocardial infarction after percutaneous coronary intervention (PCI). Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
DAT (DOAC+clopidogrel) and DOAC monotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
860 participants
Where
1 siteSouth Korea
Study dates
26 Aug 2026to 31 Dec 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 19 years old
  • Patients with AF and CHA2DS2-VA score ≥2.
  • ST-segment elevation myocardial infarction (STEMI) or Non-ST-segment elevation myocardial infarction (NSTEMI)
  • STEMI: ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle-branch block.12
  • NSTEMI: NSTEMI is defined as a combination of criteria with mandated elevation of a cardiac biomarker, preferably high-sensitive cardiac troponin with at least one value above 99th percentile of the upper reference limit and at least one of the following:12
  • Symptoms of ischemia.
Show all 11Show fewer
  • New or presumed new significant ST-T wave changes
  • Development of pathological Q waves on electrocardiography.
  • Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
  • Intracoronary thrombus detected on angiography.
  • Patients underwent PCI for AMI (STEMI or NSTEMI) at least 6 months before enrollment.

Who cannot join

  • Patients contraindicated for use of DOACs or clopidogrel
  • Mechanical prosthetic valve or moderate-to-severe mitral stenosis requiring vitamin K antagonist
  • Planned cardiac surgery within 1 year after randomization
  • Patients with severe thrombocytopenia or coagulopathy
  • Liver cirrhosis or severe hepatic dysfunction
  • Advanced chronic kidney disease (creatinine clearance <15 ml/min/1.73 m2) or on dialysis
Show all 11Show fewer
  • Prior history of intracranial hemorrhage
  • Coexisting conditions related to high risk of life-threatening bleeding
  • Pregnancy or breast feeding
  • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
  • Unwillingness or inability to comply with the procedures described in this protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Seung Hun Lee, MD, PhD contact

82-2-220-6246

lsh8602@naver.com

Joon Ho Ahn, MD, PhD contact

82-2-220-6246

yhbky@naver.com

South Korea1 site, 1 recruiting
  • Chonnam National University Hospital

    Gwangju, Gwangju, 61469

    Young Joon Hong, MD, PhD, 82-62-220-6246, hyj200@hanmail.net

    Seung Hun Lee, MD, PhD

    Recruiting

Other trials in South Korea

About this study

Official title: Heart-team for Evidence-based RevascularizatiOn: Abbreviated Antithrombotic Therapy After Percutaneous Coronary Intervention in Patients With Atrial Fibrillation and Acute Myocardial Infarction

The aim of the study is to compare clinical outcomes between direct oral anticoagulant (DOAC) monotherapy versus dual antithrombotic therapy (DOAC plus clopidogrel) in patients with atrial fibrillation and acute myocardial infarction after percutaneous coronary intervention (PCI).

Read the detailed description

Advancements in device technologies for PCI and adjunct pharmacotherapy have recently shifted research focus toward balancing bleeding risk reduction with the management of ischemic events through novel antithrombotic strategies. These trends are particularly relevant for patients with atrial fibrillation (AF) who require lifelong oral anticoagulation to prevent embolic events. Traditionally, the combination of vitamin K antagonists (such as warfarin) with antiplatelet agents has been regarded as the standard approach to mitigate ischemic risk following PCI in patients with AF. However, previous studies have consistently demonstrated that dual antithrombotic therapy (DAT) utilizing direct oral anticoagulants (DOACs) results in reduced bleeding complications compared to triple antithrombotic therapy based on warfarin.

For long-term maintenance, DOAC monotherapy is recommended, as a Class I, after 6 to 12 months post-PCI for patients with stable coronary artery disease (CAD) and AF. Recent randomized clinical trials corroborate these recommendations. The AFIRE (Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease) study showed that rivaroxaban monotherapy was non-inferior to DAT in terms of both bleeding and ischemic outcomes. The EPIC-CAD (Edoxaban versus Edoxaban with Antiplatelet Agent in Patients with Atrial Fibrillation and Chronic Stable Coronary Artery Disease) trial further extended this evidence, indicating that edoxaban monotherapy reduced the risk of net adverse clinical events (NACE)-a composite of death, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, and major or clinically relevant nonmajor bleeding-compared to DAT. Recently, the ADAPT AF-DES (Appropriate Duration of Antiplatelet and Thrombotic Strategy after 12 Months in Patients with Atrial Fibrillation Treated with Drug-Eluting Stents) trial demonstrated that DOAC monotherapy was non-inferior, and even superior, to combination therapy with a DOAC and clopidogrel regarding NACE reduction in patients with AF and stable CAD following PCI. However, these studies have primarily focused on patients with stable CAD who inherently have a lower ischemic risk. Despite limited evidence supporting DOAC monotherapy as a maintenance strategy for acute myocardial infarction (AMI) patients, recent guidelines have also recommended this approach after 1 year (Class I) or 6 months (Class IIB) following PCI in AMI setting. Furthermore, in real-world data, the DAT remained effective in reducing ischemic events without increasing the risk of bleeding compared with DOAC monotherapy. Additionally, DOAC monotherapy showed a lower risk of NACE at 3 years, but was not significantly effective at 1 year after PCI.

To address this critical evidence gap in clinical practice, we have developed the Heart-team for Evidence-based Revascularization: Abbreviated Antithrombotic Therapy After Percutaneous Coronary Intervention in Patients with Atrial Fibrillation and Acute Myocardial Infarction (HERO-AF-AMI). This study aims to evaluate the impact of DOAC monotherapy compared to DAT (DOAC plus clopidogrel) in patients with AF and AMI undergoing PCI.

Being tested
DAT (DOAC+clopidogrel), DOAC monotherapy
Keywords
AF, Myocardial infarction, STEMI, NSTEMI, DOAC, NOAC, OAC alone
Medical subject headings
Myocardial Infarction, ST Elevation Myocardial Infarction, Atrial Fibrillation, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DAT (DOAC+clopidogrel)Drug

    Patients allocated to the DAT group receive either apixaban 5 mg twice daily, edoxaban 60 mg once daily, or rivaroxaban 15 mg once daily with clopidogrel 75 mg once daily.

  • DOAC monotherapyDrug

    Patients allocated to the DOAC monotherapy group receive either apixaban 5 mg twice daily, edoxaban 60 mg once daily, or rivaroxaban 20 mg once daily.

Study groups in NCT07583784
Study groupRoleWhat they receive
DAT (DOAC+clopidogrel) groupActive comparatorPatients who were indicated lifelong oral anticoagulation for AF with a CHA2DS2-VA score equal to or greater than 2 points, and treated AMI with PCI are candidates. After 6 months of index procedure, the patients will be screened for inclusion and exclusion criteria, and eligible patients will be randomized into either the DOAC monotherapy group or the DAT group. Patients allocated to the DAT group receive either apixaban 5 mg twice daily, edoxaban 60 mg once daily, or rivaroxaban 15 mg once daily with clopidogrel 75 mg once daily.
Receives: Drug: DAT (DOAC+clopidogrel)
DOAC monotherapy groupExperimentalPatients who were indicated lifelong oral anticoagulation for AF with a CHA2DS2-VA score equal to or greater than 2 points, and treated AMI with PCI are candidates. After 6 months of index procedure, the patients will be screened for inclusion and exclusion criteria, and eligible patients will be randomized into either the DOAC monotherapy group or the DAT group. Patients allocated to the DOAC monotherapy group receive either apixaban 5 mg twice daily, edoxaban 60 mg once daily, or rivaroxaban 20 mg once daily.
Receives: Drug: DOAC monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NACE (net adverse clinical events)

    a composite of death, non-fatal MI, stroke, systemic embolization, unplanned revascularization, stent thrombosis, major or clinically relevant non-major bleeding by ISTH

    Measured: 1 year after the last patient enrollment

Secondary outcomes (15)
  1. Rate of major bleeding by ISTH

    major bleeding events by ISTH definition

    Measured: 1 year after the last patient enrollment

  2. Rate of MACCE (major adverse cardiac and cerebrovascular event)

    a composite of cardiovascular death, non-fatal MI, ischemic stroke, systemic embolization, unplanned revascularization, and stent thrombosis

    Measured: 1 year after the last patient enrollment

  3. All-cause death

    all-cause death

    Measured: 1 year after the last patient enrollment

  4. Cardiovascular death

    cardiovascular death

    Measured: 1 year after the last patient enrollment

  5. Rate of non-fatal MI

    non-fatal MI, defined by Fourth Universal definition of MI

    Measured: 1 year after the last patient enrollment

  6. Rate of ischemic stroke

    ischemic stroke

    Measured: 1 year after the last patient enrollment

  7. Rate of systemic embolization

    systemic embolization

    Measured: 1 year after the last patient enrollment

  8. Rate of unplanned revascularization

    unplanned revascularization (clinically-driven)

    Measured: 1 year after the last patient enrollment

  9. Rate of definite stent thrombosis

    definite stent thrombosis, defined by Academic Research Consortium (ARC) II consensus

    Measured: 1 year after the last patient enrollment

  10. Rate of cardiovascular death or non-fatal MI

    a composite of cardiovascular death or non-fatal MI

    Measured: 1 year after the last patient enrollment

  11. Rate of all-cause death, non-fatal MI, stroke, systemic embolization, stent thrombosis, or ISTH major bleeding

    a composite of all-cause death, non-fatal MI, stroke, systemic embolization, stent thrombosis, or ISTH major bleeding

    Measured: 1 year after the last patient enrollment

  12. Rate of major or clinically relevant non-major bleeding by ISTH

    major or clinically relevant non-major bleeding by ISTH

    Measured: 1 year after the last patient enrollment

  13. Rate of fatal bleeding by ISTH

    fatal bleeding by ISTH

    Measured: 1 year after the last patient enrollment

  14. Rate of clinically relevant non-major bleeding by ISTH

    clinically relevant non-major bleeding by ISTH

    Measured: 1 year after the last patient enrollment

  15. Rate of any bleeding by ISTH

    any bleeding by ISTH

    Measured: 1 year after the last patient enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start26 Aug 2026
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective, multi-center, open label, randomized controlled, superiority trial to compare clinical outcomes between direct oral anticoagulants (DOAC) monotherapy versus DOAC and clopidogrel as maintenance strategies in AF and AMI patients after percutaneous coronary intervention (PCI)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
860 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07583784
Sponsor's protocol ID
CNUH-AF-AMI
Acronym
HERO-AF-AMI
Status last verified
Aug 2026
First submitted
7 May 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.

Questions about this trial

What is this clinical trial studying?

A study testing DAT (DOAC+clopidogrel) and DOAC monotherapy in people with Myocardial Infarction (MI) and ST-Segment Elevation Myocardial Infarction(STEMI), run by Chonnam National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seung Hun Lee, MD, PhD (82-2-220-6246, lsh8602@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NACE (net adverse clinical events) (time frame: 1 year after the last patient enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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