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

NCT03244319 | Completed Phase 3 DMC

• 1 other identifier: 4-2017-0506
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

MV(Mitral Valve) Repair

Outcome Measures

Primary Outcomes (1)

• Occurrence of thromboembolic event

  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 Outcomes (1)

• Dysfunction of treated valve

  12 weeks

Study Arms (2)

Edoxaban

EXPERIMENTAL

Drug: Edoxaban

Warfarin

ACTIVE COMPARATOR

Drug: Warfarin; Drug: parenteral anti-coagulant (UFH)

Interventions

Edoxaban DRUG

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).

Edoxaban

Warfarin DRUG

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.

Warfarin

parenteral anti-coagulant (UFH) DRUG

parenteral anti-coagulant (UFH)

Warfarin

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Interventions

edoxaban; Warfarin

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 9, 2017
• Study Start: December 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)