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
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
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
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
