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Heart-team for Evidence-based RevascularizatiOn: Abbreviated Antithrombotic Therapy After Percutaneous Coronary Intervention in Patients With Atrial Fibrillation and Acute Myocardial Infarction

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Chonnam National University Hospital
RECRUITING
Gwangju
Contact Information
Primary
Seung Hun Lee, MD, PhD
lsh8602@naver.com
82-2-220-6246
Backup
Joon Ho Ahn, MD, PhD
yhbky@naver.com
82-2-220-6246
Time Frame
Start Date: 2026-08-26
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 860
Treatments
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.
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.
Sponsors
Leads: Chonnam National University Hospital

This content was sourced from clinicaltrials.gov