patients scheduled bioprosthetic valve replacement in either the mitral or aortic valve or both Bioprosthetic valve replacement
Conditions
Interventions
1) Investigational product, Edoxaban
Administrating edoxavan of the following dose orally once in a day.
30mg per day in patients with less than 60kg
60mg per day (2 tablets) in patients with more tha
D000925
Anticoagulants
Sponsors
Izumi Chisato
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurence rate of stroke or systemic embolism (6.3.) at 12 weeks (+ 4 weeks) after surgical intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The occurence rate of stroke, systemic embolism, or major bleedings (6.3.) at 12 weeks (+ 4 weeks) after surgical intervention 2) The events rate at 12 weeks (+ 4 weeks) after surgical intervention 3) The events rate from 12 weeks (+ 4 weeks) after surgical intervention to the end of administration of study drugs (maximum 24 weeks after surgical intervention) 4) The length of hospital stay after surgical intervention (from the day of surgical intervention to the first discharge) 5) Total frequency of blood test during this trial 6) The occurence rate of atrial fibrillation during follow-up 7) TTR time in therapeutic range (only in patients with control drugs) 8) Prevalence of administrating anti-coagulant drugs more than 12 weeks (+ 4weeks) after surgival intervention 9) Adverse events | — |
Contacts
Public ContactChisato Izumi
National Cerebral and Cardiovascular Center
Outcome results
None listed