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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030543


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name