UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036958 |
|---|---|
| Receipt number | R000041981 |
| Scientific Title | Evaluation of acute thrombus regression effect of anticoagulant for deep vein thrombosis in cancer patients |
| Date of disclosure of the study information | 2019/06/05 |
| Last modified on | 2025/02/21 10:13:40 |
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Basic information
Public title
Evaluation of acute thrombus regression effect of anticoagulant for deep vein thrombosis in cancer patients
Acronym
Evaluation of acute thrombus regression effect of anticoagulant for deep vein thrombosis in cancer patients
Scientific Title
Evaluation of acute thrombus regression effect of anticoagulant for deep vein thrombosis in cancer patients
Scientific Title:Acronym
Evaluation of acute thrombus regression effect of anticoagulant for deep vein thrombosis in cancer patients
Region
| Japan |
Condition
Condition
Deep vein thrombosis
Classification by specialty
| Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Cancer is a risk factor for deep vein thrombosis.
However, although there have been reports about prevention of recurrence of deep vein thrombosis in cancer patients using anticoagulants, there have been no reports on the thrombus regression effect of anticoagulants in the acute phase.
The purpose of this study is to examine the thrombus regression effect of early acute treatment with anticoagulants on deep vein thrombosis in cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thrombus regression effect from 7 to 14 days after initiation of anticoagulation therapy
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients who properly used Edoxaban followed by appropriate initial treatment (Heparin etc.) in the acute phase for deep vein thrombosis in cancer patients
Key exclusion criteria
1 Patients who are contraindicated with heparin sodium and/or edoxaban
2 Patients judged as inappropriate by the research doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Hisatake |
Organization
Toho Univaersity Omori Medical Center
Division name
Department of Cardiovascular Medicine
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ohta-ku, Tokyo
TEL
03-3762-4151
s-hisata@td5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Hisatake |
Organization
Toho Univaersity Omori Medical Center
Division name
Department of Cardiovascular Medicine
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ohta-ku, Tokyo
TEL
03-3762-4151
Homepage URL
s-hisata@td5.so-net.ne.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Daiichi-Sankyo Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB committe , Toho Univaersity Omori Medical Center
Address
6-11-1 Omori-nishi, Ohta-ku, Tokyo
Tel
03-3762-4151
omori.rinri@ext.toho-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
| 2019 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
file:///C:/Users/s-his/Downloads/s00380-024-02418-1%20(3).pdf
Publication of results
Published
Result
URL related to results and publications
file:///C:/Users/s-his/Downloads/s00380-024-02418-1%20(3).pdf
Number of participants that the trial has enrolled
34
Results
The QUT score of thrombus volume was calculated at baseline and after the start of edoxaban administration, using ultrasound to evaluate changes in thrombus volume.
The primary and secondary endpoints were the acute thrombus regression effect of edoxaban and the impact of clinical frailty on the thrombus regression effect, respectively.
Anticoagulant therapy with edoxaban significantly reduced QUT score.
In addition, regardless of frailty, QUT score decreased significantly.
Results date posted
| 2025 | Year | 02 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this observational study, among the inpatients with cancer and lower-extremity DVT who underwent initial treatment with edoxaban at our hospital from November 2019 to December 2021, 34 consenting patients were recruited in this study.
Participant flow
In this observational study, among the inpatients with cancer and lower-extremity DVT who underwent initial treatment with edoxaban at our hospital from November 2019 to December 2021, 34 consenting patients were recruited in this study.
Adverse events
no
Outcome measures
The primary endpoint was thrombus regression effect after the start of edoxaban administration. To examine thrombus regression effect, lower-extremity venous ultrasound was performed after the start of edoxaban administration, and the results were compared with the results of lower-extremity venous ultrasound performed before edoxaban administration, i.e., during the diagnosis of lower-extremity DVT. Thrombus volume in lower-extremity DVT was quantitatively evaluated using lower-extremity venous ultrasound. The secondary endpoint was thrombus regression effect by frailty of the participants during the diagnosis of lower-extremity DVT. Frailty was evaluated using the Clinical Frailty Scale.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is observational research
Management information
Registered date
| 2019 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041981
