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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031927
Receipt No. R000036390
Scientific Title Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation - In Atrial Fibrillation
Date of disclosure of the study information 2018/03/27
Last modified on 2021/06/21

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Basic information
Public title Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation - In Atrial Fibrillation
Acronym ENVISAGE-TAVI AF
Scientific Title Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation - In Atrial Fibrillation
Scientific Title:Acronym ENVISAGE-TAVI AF
Region
Japan Asia(except Japan) North America
Europe

Condition
Condition Atrial Fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 - To assess the effect of Edoxaban versus Vitamin K antagonist (VKA) on net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and major bleeding (International Society on Thrombosis and Haemostasis [ISTH] definition).
- To assess the effect of Edoxaban versus VKA on major bleeding (ISTH definition).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes - NACE, i.e., the composite of all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding (ISTH definition)
- Major bleeding (ISTH definition)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Edoxaban-based regimen (up to 3 years)
Interventions/Control_2 VKA (Vitamin K antagonist)-based regimen (up to 3 years)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Successful transcatheter aortic valve implantation (TAVI)
2. Indication for chronic OAC
3. Provision of signed informed consent
Key exclusion criteria 1. Conditions with a high risk of bleeding
2. Serious unresolved periprocedural complications
3. Any contraindication to both Edoxaban and VKA per local label
4. Clinically overt stroke within the last 90 days before TAVI
Target sample size 1400

Research contact person
Name of lead principal investigator
1st name George Dangas and Nicolas Van Mieghem
Middle name
Last name George Dangas and Nicolas Van Mieghem
Organization Daiichi Sankyo, Inc.
Division name Medical Affairs
Zip code 11967
Address 211 Mt Airy Road, Basking Ridge, NJ, USA
TEL +1-908-992-6400
Email munverdorben@dsi.com

Public contact
Name of contact person
1st name Yoshitaka
Middle name
Last name Kurokane
Organization Covance Japan Co., Ltd.
Division name Clinical Operations
Zip code 104-6108
Address Harumi Triton Square Office Tower Y, 8F, 1-8-11, Harumi, Chuo-ku, Tokyo
TEL +81-3-6837-9500
Homepage URL
Email yoshitaka.kurokane@covance.com

Sponsor
Institute Daiichi Sankyo, Inc.
Institute
Department

Funding Source
Organization Daiichi Sankyo, Inc.
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Corporation Okinawa Tokushukai Certified Review Board
Address 1370-1, Okamoto, Kamakura-shi, Kanagawa, Japan
Tel +81-3-3265-4804
Email r_shinsa@shonankamakura.or.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02943785
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2 jRCTs031180144
Org. issuing International ID_2 Japan Registry of Clinical Trials
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 1427
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 01 Month 15 Day
Date of IRB
2018 Year 03 Month 15 Day
Anticipated trial start date
2018 Year 05 Month 31 Day
Last follow-up date
2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2021 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036390

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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