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Completed NCT04250116

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

Conditions: Atrial Fibrillation

Sex: All
Ages: 19 Years – 85 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 960
Sponsor: Yonsei University

Location: Severance Cardiovascular Hospital, Yonsei University Health System Seoul

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.

Eligibility Criteria

Inclusion Criteria: 1. over 19 years old 2. Patient who underwent PCI with DES more than 12 months ago 3. Non-valvular atrial fibrillation patients requiring long-term anticoagulation Exclusion Criteria: 1. Over 85 years old 2. Pregnancy or Potential Pregnancy 3. Life expectancy within 1 year 4. Patients who refuse or do not understand the written consent form 5. Requiring anticoagulation due to history of mechanical valve replacement, mitral stenosis or deep vein thrombosis 6. Coagulopathy, continuous bleeding, or Hb level below 10 g/dL 7. Intracerebral hemorrhage within 2 months 8. Patients with gastrointestinal hemorrhage within three months of registration 9. Patients diagnosed with a gastrointestinal tumor that requires continuous treatment 10. Patients treated with 1st generation drug-eluting stents (Cypher, Taxus, or Endeavor Sprint)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04250116). StuddyBuddy aggregates publicly available trial information.