UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020275
Receipt number R000023406
Scientific Title Bleeding events of direct oral anti-coagulant for treatment of venous thromboembolism in advanced cancer patients.
Date of disclosure of the study information 2015/12/19
Last modified on 2019/02/14 08:38:50

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Basic information

Public title

Bleeding events of direct oral anti-coagulant for treatment of venous thromboembolism in advanced cancer patients.

Acronym

Bleeding events of direct oral anti-coagulant for treatment of venous thromboembolism in advanced cancer patients.

Scientific Title

Bleeding events of direct oral anti-coagulant for treatment of venous thromboembolism in advanced cancer patients.

Scientific Title:Acronym

Bleeding events of direct oral anti-coagulant for treatment of venous thromboembolism in advanced cancer patients.

Region

Japan


Condition

Condition

Venous thromboembolism

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to reveal the safety of direct oral anti-coagulant for treatment of venous thromboembolism in advanced cancer patients.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint is the incidence of bleeding during the 12 weeks of treatment of venous thromboembolism with direct oral anti-coagulant.

Key secondary outcomes

The secondary endpoint is the incidence of adverse events during the 12 weeks of treatment of thromboembolism with direct oral anti-coagulant.


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

1)Pathologically confirmation of cancer.
2)Advanced cancer patients.
3)Deep venous thrombosis and/or plumonary embolism.
4)Thrombus documented by contrast enhanced CT or ultrasonography.
5)Direct oral anti-coagulant is planned.
6)Written informed consent.

Key exclusion criteria

1)Other anti-coagulant or anti-platelet is administered.
2)Other disease requiring anti-coagulant therapy.
3)History of intracranial bleeding.
4)Active bleeding.
5)Thrombolytic therapy is planned.
6)Renal failure (Cre>=1.5mg/dL)
7)Platelet count <100,000/mm3

Target sample size

147


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takuya Oyakawa

Organization

Shizuoka Cancer Center

Division name

Cardiology

Zip code


Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan

TEL

(+81)055-989-5222

Email

t.oyakawa@scchr.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takuya Oyakawa

Organization

Shizuoka Cancer Center

Division name

Cardiology

Zip code


Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan

TEL

(+81)055-989-5222

Homepage URL


Email

t.oyakawa@scchr.jp


Sponsor or person

Institute

Shizuoka Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Shizuoka Cancer Center

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


Address


Tel


Email



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

2015 Year 12 Month 19 Day


Related information

URL releasing protocol


Publication of results

Published


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

2015 Year 11 Month 11 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational study.
After December 2015, the patients who meet inclusion criteria are enrolled.
We check adverse events of direct oral anti-coagulant.


Management information

Registered date

2015 Year 12 Month 19 Day

Last modified on

2019 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023406


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name