Abbreviated Antithrombotic Therapy After PCI in Patients With AF and AMI

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).

Eligibility

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.

Conditions5

Interventions2

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