Clinical trial of Edoxaban after surgical bioprosthetic valve replacement

Phase 3

• Conditions: patients scheduled bioprosthetic valve replacement in either the mitral or aortic valve or both; Bioprosthetic valve replacement; D019918

• Registration Number: JPRN-jRCT2051210209
• Lead Sponsor: Izumi Chisato

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-30
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1) patients who is scheduled to perform surgical bioprosthetic valve replacement in either the mitral or aortic valve or both
2) older than 18 or younger than 85 years old at obtaining consent
3) obtaining a document consent for the randomized controlled trial paticipation

Exclusion Criteria

1) Patients with mechanical valve; excluding patients who is scheduled to replace the mechanical valve to a bioprosthetic valve in this trial.
2) Patients with more than moderate mitral stenosis (ref. JCS/JSCS/JATS/JSVS 2020 Guidelines on the Management of Valvular Heart Disease, Circ J 2020; 84: 2037-2119); excluding patients who is scheduled to replace the mitral native valve to a bioprosthetic valve in this trial.
3) Patients with a high bleeding risk (active hemorrhage, platelets <50,000/mm3, Hb <8.0 g/dL, previous cerebral hemorrhage, active peptic ulcer, or previous upper gastrointestinal bleeding within the last 3 months.
4) Patients with a history of allergy or contraindicaton for administration of warfarin potassium or Edoxaban
5) Patients with contraindication of 30mg or 60mg per day of Edoxaban
6) Patients whose body weight is <40.0kg
7) Patients who cannot stop prohibited concomitant medications (8.5.1) in this trial
8) Patients with acute coronary syndrome within last 1 month prior to the eligibility judgement
9) Patients with symptomatic stroke within 3 month prior to the eligibility judgement
10) Patients with Ccr <30 mL/min
11) Patients with dialysis
12) Patients with more than moderate hepatic impairment or liver diseases affected to blood coagulation
Child-Pugh classification: more than class B or abnormal clinical test (Bilirubin>2 times of the upper limit, AST/ALT/ALP >3 times of the upper limit)
13) Patients who are scheduled to perform surgical intervention or treatment procedures (including endoscopy) required stopping anti-coagulants during this trial
14) Patiets who is pregnant, breastfeeding, or suspected of being pregnant, or patients who hope to get pregnant during this trial
15) Patients with infective endocarditis
16) Patients with active malignancy
17) Patients who have already particiated or plan to participate in other clinical or randomized trials
18) Patients who are judged to be inappropriate by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified