UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bleeding events of direct oral anti-coagulant for treatment of venous thromboembolism in advanced cancer patients.
Title of the study (Brief title)	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	Takuya Oyakawa
Organization	Shizuoka Cancer Center
Division name	Cardiology
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	Takuya Oyakawa
Organization	Shizuoka Cancer Center
Division name	Cardiology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL	(+81)055-989-5222
Homepage URL
Email	t.oyakawa@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023406