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

30 de agosto de 2026 atualizado por: 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).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

860

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Seung Hun Lee, MD, PhD
  • Número de telefone: 82-2-220-6246
  • E-mail: lsh8602@naver.com

Estude backup de contato

  • Nome: Joon Ho Ahn, MD, PhD
  • Número de telefone: 82-2-220-6246
  • E-mail: yhbky@naver.com

Locais de estudo

  • Coréia do Sul
    • Gwangju
      • Gwangju, Gwangju, Coréia do Sul, 61469
        • Recrutamento
        • Chonnam National University Hospital
        • Subinvestigador:
          • Seung Hun Lee, MD, PhD
        • Investigador principal:
          • Young Joon Hong, MD, PhD
        • Subinvestigador:
          • Joon Ho Ahn, MD, PhD
        • Contato:
        • Contato:
          • Seung Hun Lee, MD, PhD
        • Subinvestigador:
          • Seok Oh, MD, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Medicamento: 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.
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
NACE (net adverse clinical events)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Rate of major bleeding by ISTH
Prazo: 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)
Prazo: 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
Prazo: 1 year after the last patient enrollment
all-cause death
1 year after the last patient enrollment
Cardiovascular death
Prazo: 1 year after the last patient enrollment
cardiovascular death
1 year after the last patient enrollment
Rate of non-fatal MI
Prazo: 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
Prazo: 1 year after the last patient enrollment
ischemic stroke
1 year after the last patient enrollment
Rate of systemic embolization
Prazo: 1 year after the last patient enrollment
systemic embolization
1 year after the last patient enrollment
Rate of unplanned revascularization
Prazo: 1 year after the last patient enrollment
unplanned revascularization (clinically-driven)
1 year after the last patient enrollment
Rate of definite stent thrombosis
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 1 year after the last patient enrollment
any bleeding by ISTH
1 year after the last patient enrollment

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Blood pressure control status
Prazo: 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
Prazo: 1 year after the last patient enrollment
AF episode frequency and lasting time
1 year after the last patient enrollment
AF burden (%)
Prazo: 1 year after the last patient enrollment
AF burden (%)
1 year after the last patient enrollment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Chonnam National University Hospital

Investigadores

  • Cadeira de estudo: Young Joon Hong, MD, PhD, Chonnam National University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

26 de agosto de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2031

Conclusão do estudo (Estimado)

31 de dezembro de 2032

Datas de inscrição no estudo

Enviado pela primeira vez

7 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de maio de 2026

Primeira postagem (Real)

13 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CNUH-AF-AMI

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

After publication of main paper.

Critérios de acesso de compartilhamento IPD

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

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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