Explore the Efficacy and Safety of edoxabaN in Patients After Heart Valve Repair or Bioprosthetic vaLve Replacement (ENAVLE Trial)

PHASE3CompletedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

December 1, 2017

Primary Completion Date

September 30, 2019

Study Completion Date

September 30, 2019

Conditions
MV(Mitral Valve) Repair
Interventions
DRUG

Edoxaban

Patients who are randomly assigned to edoxaban group will be received 60mg qd or 30mg qd (creatinine clearance 30-49ml/min, body weight \<60kg or concomitant use of certain P-glycoprotein inhibitors).

DRUG

Warfarin

All patients who are assigned to VKA group, bridging with warfarin and UFH is mandatory until INR reach therapeutic target range (INR 2-3). Warfarin dose will be adjusted for maintain therapeutic range (INR 2-3) during follow up period.

DRUG

parenteral anti-coagulant (UFH)

parenteral anti-coagulant (UFH)

Trial Locations (1)

03722

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT03244319 - Explore the Efficacy and Safety of edoxabaN in Patients After Heart Valve Repair or Bioprosthetic vaLve Replacement (ENAVLE Trial) | Biotech Hunter | Biotech Hunter