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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041973
Receipt No. R000047910
Scientific Title Anticoagulant effects of Edoxiaban and those inhibitors in cancer and non-cancer patients with venous thromboembolism.
Date of disclosure of the study information 2020/10/05
Last modified on 2020/10/01

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Basic information
Public title Anticoagulant effects of Edoxiaban and those inhibitors in patients with venous thromboembolism.
Acronym EVE study
Scientific Title Anticoagulant effects of Edoxiaban and those inhibitors in cancer and non-cancer patients with venous thromboembolism.
Scientific Title:Acronym EVE study
Region
Japan

Condition
Condition Venous thromboembolism (VTE)
Classification by specialty
Medicine in general Cardiology Hematology and clinical oncology
Surgery in general Obsterics and gynecology Oto-rhino-laryngology
Orthopedics Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare the anticoagulant effects of Edoxaban in cancer and non-cancer patients by measuring the PT, APTT and D-dimer value after Edoxaban administration.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes PT, APTT and D-dimer value after Edoxaban administration.
Key secondary outcomes Compare delta PT and delta APTT (difference in PT or APTT value before and 5 hours after Edoxaban administration) in cancer and non-cancer patients.
Identify the time when D-dimer decrease below 50% of baseline value.
Compare changes of D-dimer value after Edoxaban administration in cancer and non-cancer patients.
Identify factors those inhibit PT and APTT prolongation by Edoxaban administration.
Identify factors those inhibit D-dimer decrease by Edoxaban administration.
Assess recurrent VTE, interruption of Edoxaban administration, major bleeding events, clinically relevant non-major bleeding events and death.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Patients taking Edoxaban after VTE diagnosis.
Key exclusion criteria Patients under 20 years-old.
Patients with hemodynamically insufficiency.
Patients who need thrombolytic therapy or emergent thrombectomy.
Terminal cancer patients those life prognosis are less than 3 months.
Patients taking Edoxaban, unfractionated heparin or fondaparinux before VTE diagnosis.
Target sample size 800

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name Yoshida
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name Department of CKD and CVD
Zip code 700-8558
Address 2-5-1, Shikata-cho, Kitaku, Okayama city, Okayama, Japan
TEL 0862357351
Email yoshid-m@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Yoshida
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name Department of CKD and CVD
Zip code 700-8558
Address 2-5-1, Shikata-cho, Kitaku, Okayama city, Okayama, Japan
TEL 0862357351
Homepage URL
Email yoshid-m@cc.okayama-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Institute
Department

Funding Source
Organization Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1, Shikata-cho, Kitaku, Okayama city, Okayama, Japan
Tel 0862356938
Email Mae6605@adm.okayama-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 05 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
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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 13 Day
Date of IRB
2019 Year 11 Month 08 Day
Anticipated trial start date
2020 Year 10 Month 05 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter cohort study

Management information
Registered date
2020 Year 10 Month 01 Day
Last modified on
2020 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047910

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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