Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Atrial Fibrillation
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 19 years and 85 years
Gender
Both males and females

Description

Atrial fibrillation(AF) patients who had undergone PCI with DES implantation at 12-18 months ago will be enrolled in this study. Decision for the antiplatelet agent discontinuation would be determined by randomization. Apixaban would be prescribed to reduced the risk stroke or systemic embolism evok...

Atrial fibrillation(AF) patients who had undergone PCI with DES implantation at 12-18 months ago will be enrolled in this study. Decision for the antiplatelet agent discontinuation would be determined by randomization. Apixaban would be prescribed to reduced the risk stroke or systemic embolism evoked by AF, and the administration of Warfarin, a vitamin-K dependent anticoagulant, would also be allowed according to attending physician's decision. The following criteria should be followed for the reduction of dosages according to the patient's renal function and other systemic conditions. Warfarin is administered to patients with creatinine clearance of 15 ml / min or dialysis. The drugs used in this study correspond to the international treatment guidelines after coronary intervention in patients with atrial fibrillation.NOAC and antiplatelet agents would be prescribed upon an outpatient visit. Clinical outcome would be followed for 2 years after study enrollment and randomization. Screening Baseline Serum AST/ALT level Creatinine clearance (mL/min) Concurrent administration of CYP3A4 agents: Ketoconazole, Itraconazole, Iopinavir/ritonavir, indinavir/ritonavir, conviaptan Dose reduction (patients meeting both criteria would be prescribed with Apixaban 2.5 mb bid) 15 mL/min ? eGFR < 30 mL/min ESRD patients under 60 kg of bodyweight or age over 80 years old.

Tracking Information

NCT #
NCT04250116
Collaborators
Not Provided
Investigators
Not Provided