drugset
drugset / Trial / NCT04250116

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

NCT04250116 ↗

Phase 4 Active not recruiting 960 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-04-28
Primary completion
2025-04
Completion
2026-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clopidogrel Small molecule 75 mg —
Background Apixaban Small molecule 2.5 mg —
Background Apixaban Small molecule 5 mg —
Background Rivaroxaban Other / unclassified 10 mg —
Background Rivaroxaban Other / unclassified 15 mg —
Background Rivaroxaban Other / unclassified 20 mg —
Background Warfarin Small molecule — —

Indications

atrial fibrillation