Clinical Trial

Appropriate Duration of Anti-Platelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug Eluting Stents

Active, Not Recruiting Phase 4
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Record status
This record was last updated January 22, 2025 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.
Summary
Atrial fibrillation patients with risk factors for stroke and systemic embolism require long-term anticoagulant therapy. Recently, non-vitamin K antagonist oral anticoagulant (NOAC) has shown their excellent safety and efficacy, and thus are widely accepted in clinical practice. Meanwhile, after percutaneous coronary intervention (PCI) using the drug-eluting stents due to coronary artery disease, the administration of one or more antiplatelets is essential to prevent the recurrence of stent thrombosis and myocardial infarction. Combined administration of anticoagulants and antiplatelets significantly lowers the incidence of ischemic events such as stroke and myocardial infarction, however, it also significantly increases the likelihood of bleeding leading to hospitalization, and or even death, thereby significantly affecting the clinical course of the AF patients who underwent PCI. Nevertheless, due to the very high mortality rate of stent thrombosis, the current standard of care guidelines recommend triple therapy with anticoagulants and double antiplatelet therapy (DAPT) in patients with atrial fibrillation for 1 month after coronary intervention, followed by co-administration of NOAC with single antiplatelet agent for 1 year. However, little is known after the optimal therapeutic strategy after 1 year. The purpose of this study is to compare the clinical results of single anticoagulant and clopidogrel combination therapy for maintenance therapy after 1 year in patients with atrial fibrillation.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-01-29; most recent amendment 2025-01-20.
Status change: Recruiting → Active, Not Recruiting 2025-01-20
Status change: Not Yet Recruiting → Recruiting 2020-08-12
Trial Details
NCT Number NCT04250116
Lead Sponsor Yonsei University
Conditions Atrial Fibrillation
Enrollment 960 participants
Start Date 2020-04-28
Primary Completion 2025-04 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2025-01-22