NCT04258488

Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement

Randomized, Evaluation of Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Joon Bum Kim · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.

Conditions

• AORTIC VALVE DISEASES
• Thromboembolism

Interventions

Type	Name	Description
DRUG	Rivaroxaban Oral Tablet	For 12months, Rivaroxaban oral tablet 20mg once daily For renal disorder subjects\_creatinine clearance 15-49 mL/min, 15mg once daily
DRUG	Vitamin K antagonist(warfarin)	For 12months, keep the international normalized ratio (INR) 1.7-3.0

Timeline

• Start date: 2022-02-21
• Primary completion: 2027-12-31
• Completion: 2028-12-30
• First posted: 2020-02-06
• Last updated: 2025-12-29

Locations

15 sites across 1 country: South Korea