UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044816 |
|---|---|
| Receipt number | R000051183 |
| Scientific Title | Contemporary Management and Outcomes in Patients With Venous Thromboembolism Registry 2 |
| Date of disclosure of the study information | 2021/07/09 |
| Last modified on | 2022/10/28 13:50:57 |
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Basic information
Public title
Contemporary Management and Outcomes in Patients With Venous Thromboembolism Registry 2
Acronym
COMMAND VTE Registry 2
Scientific Title
Contemporary Management and Outcomes in Patients With Venous Thromboembolism Registry 2
Scientific Title:Acronym
COMMAND VTE Registry 2
Region
| Japan |
Condition
Condition
Venous thromboembolism, Pulmonary embolism, Deep vein thrombosis
Classification by specialty
| Medicine in general | Cardiology | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the current study is to investigate the contemporary management and outcomes in patients with acute symptomatic venous thromboembolism (pulmonary embolism and deep vein thrombosis) in the real-world clinical practice in the Era of DOAC.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
All-cause death, Recurrence of symptomatic VTE, Bleeding event
Key secondary outcomes
Stroke, Invasive treatment, Development of new cancer
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
From January 2015 to August 2020
1) acute and symptomatic pulmonary embolism patients diagnosed by imaging test
2) acute and symptomatic deep vein thrombosis patients diagnosed by imaging test
3) Patients with both 1) and 2)
Key exclusion criteria
None
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Yugo |
| Middle name | |
| Last name | Yamashita |
Organization
Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-4255
yyamashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yugo |
| Middle name | |
| Last name | Yamashita |
Organization
Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-4255
Homepage URL
yyamashi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
| 2021 | Year | 07 | Month | 09 | 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
5197
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
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 07 | Month | 09 | Day |
Last modified on
| 2022 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051183
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
