UMIN-CTR Clinical Trial

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
Email	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
Email	yhasegawa@chiba-cc.jp

Sponsor
Institute	Chiba Cancer Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030543