UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041973 |
|---|---|
| Receipt number | 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 | 2025/05/31 13:00:46 |
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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 | Obstetrics 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
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
yoshid-m@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Institute
Department
Personal name
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
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
https://thrombosisjournal.biomedcentral.com/articles/10.1186/s12959-025-00720-0
Publication of results
Published
Result
URL related to results and publications
https://thrombosisjournal.biomedcentral.com/articles/10.1186/s12959-025-00720-0
Number of participants that the trial has enrolled
243
Results
PT and APTT at 5 h after initial edoxaban administration were not significantly different between the cancer and noncancer groups. However, D-dimer in the cancer groups was significantly greater than that in the noncancer groups. PT and APTT significantly decreased from 5 h to overnight after edoxaban, but a similar pattern was observed in each group. All adverse events after edoxaban administration were also similar between the cancer and noncancer groups.
Results date posted
| 2025 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 04 | Month | 16 | Day |
Baseline Characteristics
Edoxaban, a direct oral anticoagulant (DOAC), is a first-line treatment for venous thromboembolism (VTE) and for preventing its recurrence. However, in patients with cancer, recurrent VTE after DOAC treatment may occur more frequently than in noncancer patients. This study aimed to test the hypothesis that the anticoagulant effect of edoxaban is lower in VTE patients with cancer than in those without cancer.
Participant flow
Patients with newly diagnosed VTE receiving edoxaban for treatment were eligible for inclusion. VTE was diagnosed by imaging tests (lower-limb venous ultrasound and/or contrast-enhanced computed tomography). Patients were not eligible if they met any of the following exclusion criteria: were younger than 20 years old; had hemodynamical instability; were treated with thrombolytic therapy or thrombectomy; had advanced cancer and were expected to have a life expectancy of less than 3 months; were taking direct oral anticoagulants 48 h before initial edoxaban administration; had a continuous infusion of unfractionated heparin 3 h before initial edoxaban administration; had a subcutaneous infusion of enoxaparin 12 h before initial edoxaban administration; had a subcutaneous infusion of fondaparinux 24 h before initial edoxaban administration; had active bleeding or high risk of bleeding; had a risk of serious complications due to bleeding; had an uncontrolled blood pressure; had a coagulation disorder; had a cirrhosis; and were pregnant; had an acute bacterial endocarditis and creatinine clearance of < 15 mL/min. After determination of the treatment protocol, written informed consent was obtained before the initial blood test.
Adverse events
All-cause death occurred in 8 patients (4%) due to progression of cancer or pneumonia, and VTE recurrence occurred in 4 (2%) overall patients. Major bleeding and clinically relevant nonmajor bleeding occurred in 5 patients (2%) and 6 (3%) overall. Discontinuation of edoxaban occurred in 20 patients because of VTE recurrence or bleeding. The proportion of each adverse event was similar between the cancer and noncancer groups.
Outcome measures
This was a prospective, multicenter, observational study conducted in Japan, including patients treated with edoxaban for VTE. The primary outcome was the difference in prothrombin time (PT), activated partial thromboplastin time (APTT), and D-dimer levels at 5 hours after the initial dose of edoxaban between cancer and noncancer groups. An additional outcome was the longitudinal change in PT and APTT from 5 hours to overnight after administration. The incidence of adverse events was also evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Multicenter cohort study
Management information
Registered date
| 2020 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047910
