Abbreviated Antithrombotic Therapy After PCI in Patients With AF and AMI

NCT07583784 | Not Yet Recruiting DMC

• 1 other identifier: CNUH-AF-AMI
• Study Type: interventional
• Target: 860
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Myocardial Infarction (MI); ST-Segment Elevation Myocardial Infarction(STEMI); NSTEMI - Non-ST-Segment Elevation Myocardial Infarction; AF - Atrial Fibrillation

Keywords

AF; Myocardial infarction; STEMI; NSTEMI; DOAC; NOAC; OAC alone

Outcome Measures

Primary Outcomes (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

  1 year after the last patient enrollment

Secondary Outcomes (15)

• Rate of major bleeding by ISTH

  1 year after the last patient enrollment

• Rate of MACCE (major adverse cardiac and cerebrovascular event)

  1 year after the last patient enrollment

• All-cause death

  1 year after the last patient enrollment

• Cardiovascular death

  1 year after the last patient enrollment

• Rate of non-fatal MI

  1 year after the last patient enrollment

Other Outcomes (3)

• Blood pressure control status

  1 year after the last patient enrollment

• AF rhythm event

  1 year after the last patient enrollment

• AF burden (%)

  1 year after the last patient enrollment

Study Arms (2)

DAT (DOAC+clopidogrel) group

ACTIVE COMPARATOR

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)

DOAC monotherapy group

EXPERIMENTAL

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

Interventions

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.

DAT (DOAC+clopidogrel) group

DOAC monotherapy DRUG

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.

DOAC monotherapy group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Sites (1)

Chonnam National University Hospital

Gwangju, Gwangju, 61469, South Korea

Location

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction; Atrial Fibrillation; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arrhythmias, Cardiac

Study Officials

• Young Joon Hong, MD, PhD

  Chonnam National University

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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)

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of main paper.
• Access Criteria: Executive Committee will discuss to share the de-identified data upon reasonable requests.

Locations

KR (1)