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

December 27, 2019 updated by: Yonsei University
  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) Efficacy Endpoint Evaluation: Occurrence of thromboembolic events and any thrombus at repaired ring or bioprosthetic valves detected by follow up echocardiography or 3D CT scan

2) Safety Endpoint Evaluation

  • Dysfunction of treated valve caused by thrombosis on echocardiography or 3D CT scan
  • Major or minor bleeding described in safety outcomes

Study Overview

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 route. All study patients started to receive bridging therapy with parenteral anti-coagulant (UFH) according to local practice before switching to warfarin or edoxaban. Among patients who take warfarin, international normalized ratio will be used to monitor the effectiveness of the anticoagulant warfarin as usual daily practice. 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. 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). Both drugs will be maintained for 3 months. During study period, all patients will be carefully monitored for thromboembolic events including valve dysfunction, and stroke or bleeding complication. At 3 months after surgery, 3 dimensional CT scan and echocardiography will be performed for detecting valvular dysfunction, any thrombus or bleeding in heart & lung.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 03722
        • Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 20-85 years with
  • MV repair or Bioprosthetic MV or AV replacement
  • Patients with written informed consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
parenteral anti-coagulant (UFH)
Experimental: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of thromboembolic event
Time Frame: 12 weeks
Occurrence of thromboembolic events and any thrombus at repaired ring or bioprosthetic valves detected by follow up echocardiography or 3D CT scan
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysfunction of treated valve
Time Frame: 12 weeks
Dysfunction of treated valve caused by thrombosis on echocardiography or 3D CT scan
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

August 6, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 9, 2017

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 27, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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