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Abbreviated Antithrombotic Therapy After PCI in Patients With AF and AMI (HERO-AF-AMI)

30. August 2026 aktualisiert von: Young Joon Hong, Chonnam National University Hospital

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).

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

860

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Seung Hun Lee, MD, PhD
  • Telefonnummer: 82-2-220-6246
  • E-Mail: lsh8602@naver.com

Studieren Sie die Kontaktsicherung

  • Name: Joon Ho Ahn, MD, PhD
  • Telefonnummer: 82-2-220-6246
  • E-Mail: yhbky@naver.com

Studienorte

  • Südkorea
    • Gwangju
      • Gwangju, Gwangju, Südkorea, 61469
        • Rekrutierung
        • Chonnam National University Hospital
        • Unterermittler:
          • Seung Hun Lee, MD, PhD
        • Hauptermittler:
          • Young Joon Hong, MD, PhD
        • Unterermittler:
          • Joon Ho Ahn, MD, PhD
        • Kontakt:
        • Kontakt:
          • Seung Hun Lee, MD, PhD
        • Unterermittler:
          • Seok Oh, MD, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Patients aged 19 years old
  2. Patients with AF and CHA2DS2-VA score ≥2.

  3. 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

      1. Symptoms of ischemia.
      2. New or presumed new significant ST-T wave changes
      3. Development of pathological Q waves on electrocardiography.
      4. Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
      5. Intracoronary thrombus detected on angiography.
  4. Patients underwent PCI for AMI (STEMI or NSTEMI) at least 6 months before enrollment.

Exclusion Criteria:

  1. Patients contraindicated for use of DOACs or clopidogrel
  2. Mechanical prosthetic valve or moderate-to-severe mitral stenosis requiring vitamin K antagonist
  3. Planned cardiac surgery within 1 year after randomization
  4. Patients with severe thrombocytopenia or coagulopathy
  5. Liver cirrhosis or severe hepatic dysfunction
  6. Advanced chronic kidney disease (creatinine clearance <15 ml/min/1.73 m2) or on dialysis
  7. Prior history of intracranial hemorrhage
  8. Coexisting conditions related to high risk of life-threatening bleeding
  9. Pregnancy or breast feeding
  10. 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)
  11. Unwillingness or inability to comply with the procedures described in this protocol.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: DAT (DOAC+clopidogrel) group
Patients 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.
Arzneimittel: DAT (DOAC+clopidogrel)
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.
Experimental: DOAC monotherapy group
Patients 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.
Arzneimittel: DOAC monotherapy
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
NACE (net adverse clinical events)
Zeitfenster: 1 year after the last patient enrollment
a composite of death, non-fatal MI, stroke, systemic embolization, unplanned revascularization, stent thrombosis, major or clinically relevant non-major bleeding by ISTH
1 year after the last patient enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of major bleeding by ISTH
Zeitfenster: 1 year after the last patient enrollment
major bleeding events by ISTH definition
1 year after the last patient enrollment
Rate of MACCE (major adverse cardiac and cerebrovascular event)
Zeitfenster: 1 year after the last patient enrollment
a composite of cardiovascular death, non-fatal MI, ischemic stroke, systemic embolization, unplanned revascularization, and stent thrombosis
1 year after the last patient enrollment
All-cause death
Zeitfenster: 1 year after the last patient enrollment
all-cause death
1 year after the last patient enrollment
Cardiovascular death
Zeitfenster: 1 year after the last patient enrollment
cardiovascular death
1 year after the last patient enrollment
Rate of non-fatal MI
Zeitfenster: 1 year after the last patient enrollment
non-fatal MI, defined by Fourth Universal definition of MI
1 year after the last patient enrollment
Rate of ischemic stroke
Zeitfenster: 1 year after the last patient enrollment
ischemic stroke
1 year after the last patient enrollment
Rate of systemic embolization
Zeitfenster: 1 year after the last patient enrollment
systemic embolization
1 year after the last patient enrollment
Rate of unplanned revascularization
Zeitfenster: 1 year after the last patient enrollment
unplanned revascularization (clinically-driven)
1 year after the last patient enrollment
Rate of definite stent thrombosis
Zeitfenster: 1 year after the last patient enrollment
definite stent thrombosis, defined by Academic Research Consortium (ARC) II consensus
1 year after the last patient enrollment
Rate of cardiovascular death or non-fatal MI
Zeitfenster: 1 year after the last patient enrollment
a composite of cardiovascular death or non-fatal MI
1 year after the last patient enrollment
Rate of all-cause death, non-fatal MI, stroke, systemic embolization, stent thrombosis, or ISTH major bleeding
Zeitfenster: 1 year after the last patient enrollment
a composite of all-cause death, non-fatal MI, stroke, systemic embolization, stent thrombosis, or ISTH major bleeding
1 year after the last patient enrollment
Rate of major or clinically relevant non-major bleeding by ISTH
Zeitfenster: 1 year after the last patient enrollment
major or clinically relevant non-major bleeding by ISTH
1 year after the last patient enrollment
Rate of fatal bleeding by ISTH
Zeitfenster: 1 year after the last patient enrollment
fatal bleeding by ISTH
1 year after the last patient enrollment
Rate of clinically relevant non-major bleeding by ISTH
Zeitfenster: 1 year after the last patient enrollment
clinically relevant non-major bleeding by ISTH
1 year after the last patient enrollment
Rate of any bleeding by ISTH
Zeitfenster: 1 year after the last patient enrollment
any bleeding by ISTH
1 year after the last patient enrollment

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Blood pressure control status
Zeitfenster: 1 year after the last patient enrollment
mean value, variability, and control rate of blood pressure
1 year after the last patient enrollment
AF rhythm event
Zeitfenster: 1 year after the last patient enrollment
AF episode frequency and lasting time
1 year after the last patient enrollment
AF burden (%)
Zeitfenster: 1 year after the last patient enrollment
AF burden (%)
1 year after the last patient enrollment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Chonnam National University Hospital

Ermittler

  • Studienstuhl: Young Joon Hong, MD, PhD, Chonnam National University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. August 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2031

Studienabschluss (Geschätzt)

31. Dezember 2032

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2026

Zuerst gepostet (Tatsächlich)

13. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CNUH-AF-AMI

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.

IPD-Sharing-Zeitrahmen

After publication of main paper.

IPD-Sharing-Zugriffskriterien

Executive Committee will discuss to share the de-identified data upon reasonable requests.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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