Status:
COMPLETED
Explore the Efficacy and Safety of edoxabaN in Patients After Heart Valve Repair or Bioprosthetic vaLve Replacement (ENAVLE Trial)
Lead Sponsor:
Yonsei University
Conditions:
MV(Mitral Valve) Repair
Eligibility:
All Genders
20-85 years
Phase:
PHASE3
Brief Summary
1. objectives: The primary aim of ENAVLE is to explore the efficacy of edoxaban in patients with post mitral valve repair or bioprosthetic valve implantation 2. Primary / Secondary Endpoint 1\) Effic...
Detailed Description
This study is an open labeled, parallel group, and randomization study. At 7 days after mitral valve repair, bioprosthetic MV or AV replacement surgery, warfarin or edoxaban will be started per oral r...
Eligibility Criteria
Inclusion
- Patients aged 20-85 years with
- MV repair or Bioprosthetic MV or AV replacement
- Patients with written informed consent
Exclusion
- Previous mechanical prosthetic heart valve replacement
- Patients who underwent TAVI
- Concomitant bioprosthetic valve replacement of mechanical tricuspid or pulmonary replacement at the time of the index valve replacement surgery
- Clinically relevant paravalvular leaks
- Previous history of endocarditis
- Complex congenital heart abnormality
- Acute coronary syndrome within one month
- Uncontrolled hypertension
- Previous history of hemorrhagic stroke
- At high risk for bleeding
- Active hepatitis or liver dysfunction (AST/ALT\> 3times of upper normal limits)
- Creatinine clearance \< 30ml/min
- Patients with a clear indication for long-term dual antiplatelet therapy
- Malignancy or radiation therapy within one month
- Treatment with selected drugs that my interact with edoxaban (specific P-gp inhibitors, ie. verapamil, quinidine; the short-term use of azithromycin, clarithromycin, erythromycin, oral itraconazole, oral ketoconazole)
- At of pregnancy or breastfeeding
- Known allergy to warfarin or edoxaban
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03244319
Start Date
December 1 2017
End Date
September 30 2019
Last Update
January 2 2020
Active Locations (1)
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1
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea, 03722