Abbreviated antithrombotic therapy after PCI in AF and MI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares two antithrombotic strategies in patients with atrial fibrillation who have undergone PCI after a myocardial infarction. It examines whether direct oral anticoagulant (DOAC) monotherapy can provide similar protection from ischemic events with less bleeding compared with dual therapy that combines a DOAC with clopidogrel. The trial builds on prior evidence from AF and CAD trials suggesting DOAC monotherapy may reduce bleeding while maintaining efficacy. Participants are adults with AF and a CHA2DS2-VA score ≥2, who had STEMI or NSTEMI and underwent PCI at least six months prior. The study is led by Chonnam National University Hospital in Gwangju, with no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chonnam National University Hospital
  Gwangju, Gwangju, South Korea Recruiting

Study contacts

• Study coordinator: Seung Hun Lee, MD, PhD
• Email: lsh8602@naver.com
• Phone: 82-2-220-6246

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.