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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction (MI); AF - Atrial Fibrillation; NSTEMI - Non-ST-Segment Elevation Myocardial Infarction; ST-Segment Elevation Myocardial Infarction(STEMI)
• Intervention / Treatment: Drug: DAT (DOAC+clopidogrel); Drug: DOAC monotherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 860
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seung Hun Lee, MD, PhD; Phone Number: 82-2-220-6246; Email: lsh8602@naver.com
• Study Contact Backup: Name: Joon Ho Ahn, MD, PhD; Phone Number: 82-2-220-6246; Email: yhbky@naver.com

Study Locations

• South Korea
  • Gwangju
    • Gwangju, Gwangju, South Korea, 61469
      • Chonnam National University Hospital
      • Sub-Investigator: Seung Hun Lee, MD, PhD
      • Principal Investigator: Young Joon Hong, MD, PhD
      • Sub-Investigator: Joon Ho Ahn, MD, PhD
      • Contact: Young Joon Hong, MD, PhD; Phone Number: 82-62-220-6246; Email: hyj200@hanmail.net
      • Contact: Seung Hun Lee, MD, PhD
      • Sub-Investigator: Seok Oh, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year after the last patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of major bleeding by ISTH	major bleeding events by ISTH definition	1 year after the last patient enrollment
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	1 year after the last patient enrollment
All-cause death	all-cause death	1 year after the last patient enrollment
Cardiovascular death	cardiovascular death	1 year after the last patient enrollment
Rate of non-fatal MI	non-fatal MI, defined by Fourth Universal definition of MI	1 year after the last patient enrollment
Rate of ischemic stroke	ischemic stroke	1 year after the last patient enrollment
Rate of systemic embolization	systemic embolization	1 year after the last patient enrollment
Rate of unplanned revascularization	unplanned revascularization (clinically-driven)	1 year after the last patient enrollment
Rate of definite stent thrombosis	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	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	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	major or clinically relevant non-major bleeding by ISTH	1 year after the last patient enrollment
Rate of fatal bleeding by ISTH	fatal bleeding by ISTH	1 year after the last patient enrollment
Rate of clinically relevant non-major bleeding by ISTH	clinically relevant non-major bleeding by ISTH	1 year after the last patient enrollment
Rate of any bleeding by ISTH	any bleeding by ISTH	1 year after the last patient enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure control status	mean value, variability, and control rate of blood pressure	1 year after the last patient enrollment
AF rhythm event	AF episode frequency and lasting time	1 year after the last patient enrollment
AF burden (%)	AF burden (%)	1 year after the last patient enrollment

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Investigators: Study Chair: Young Joon Hong, MD, PhD, Chonnam National University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NOAC; STEMI; Myocardial infarction; NSTEMI; AF; DOAC; OAC alone
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Atrial Fibrillation; Myocardial Infarction
• Other Study ID Numbers: CNUH-AF-AMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.
• IPD Sharing Time Frame: After publication of main paper.
• IPD Sharing Access Criteria: Executive Committee will discuss to share the de-identified data upon reasonable requests.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No