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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Apixaban; Clopidogrel

Criteria

Inclusion Criteria:

1. over 19 years old

2. Patient who underwent PCI with DES 12 months to 18 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)