UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026600 |
|---|---|
| Receipt number | R000030543 |
| Scientific Title | A randomised controlled trial with rivaroxaban and apixaban in the treatment for venous thromboembolism in cancer patients |
| Date of disclosure of the study information | 2017/03/17 |
| Last modified on | 2021/03/28 11:25:07 |
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Basic information
Public title
A randomised controlled trial with rivaroxaban and apixaban in the treatment for venous thromboembolism in cancer patients
Acronym
Comparison between rivaroxaban and apixaban in the treatment for venous thromboembolism in cancer patients
Scientific Title
A randomised controlled trial with rivaroxaban and apixaban in the treatment for venous thromboembolism in cancer patients
Scientific Title:Acronym
Comparison between rivaroxaban and apixaban in the treatment for venous thromboembolism in cancer patients
Region
| Japan |
Condition
Condition
Venous thromboembolism with cancer patients
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Compare rivaroxaban and apixaban in the treatment for venous thromboembolism in cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of venous thromboembolism
Hemorrhage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
take rivaroxaban
Interventions/Control_2
take apixaban
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Venous thromboembolism of cancer patients
Key exclusion criteria
hemorrhage patients
Contra-indication to the treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuzo |
| Middle name | |
| Last name | Hasegawa |
Organization
Chiba Cancer Center
Division name
Neurological Surgery
Zip code
206-8717
Address
666-2, Nitona-cho, Chuo-ku, Chiba-shi, Chiba
TEL
043-264-5431
yhasegawa@chiba-cc.jp
Public contact
Name of contact person
| 1st name | Yuzo |
| Middle name | |
| Last name | Hasegawa |
Organization
Chiba Cancer Center
Division name
Neurological Surgery
Zip code
260-8717
Address
666-2, Nitona-cho, Chuo-ku, Chiba-shi, Chiba
TEL
043-264-5431
Homepage URL
yhasegawa@chiba-cc.jp
Sponsor or person
Institute
Chiba Cancer Center
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Cancer Center
Address
666-2, Nitona-cho, Chuo-ku, Chiba-shi, Chiba
Tel
0432645431
ntanimura@chiba-cc.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
| 2017 | Year | 03 | Month | 17 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2017 | Year | 03 | Month | 17 | Day |
Last modified on
| 2021 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030543
