UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021132 |
|---|---|
| Receipt number | R000024344 |
| Scientific Title | Contemporary Management And Outcomes In Patients With Venous Thromboembolism Registry |
| Date of disclosure of the study information | 2016/02/22 |
| Last modified on | 2018/03/25 23:03:08 |
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Basic information
Public title
Contemporary Management And Outcomes In Patients With Venous Thromboembolism Registry
Acronym
COMMAND VTE Registry
Scientific Title
Contemporary Management And Outcomes In Patients With Venous Thromboembolism Registry
Scientific Title:Acronym
COMMAND VTE Registry
Region
| Japan |
Condition
Condition
Venous Thromboembolism (Pulmonary embolism and Deep vein thrombosis)
Classification by specialty
| Medicine in general | Cardiology | Clinical immunology |
| Surgery in general | Obstetrics and Gynecology | Orthopedics |
| Urology |
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.
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
Acute myocardial infarction, Stroke, Invasive treatment, Postthrombotic syndrome
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 2010 to August 2014
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
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kimura |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-4255
taketaka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yugo Yamashita |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
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
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Ministry of Health, Labor and Welfare in Japan and Pharmaceuticals and Medical Devices Agency
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
京都大学医学部付属病院
大阪赤十字病院
日本赤十字社和歌山医療センター
天理よろづ相談所病院
神戸市立医療センター中央市民病院
倉敷中央病院
兵庫県立尼崎総合医療センター
市立岸和田市民病院
湖東記念病院
枚方公済病院
近畿大学医学部奈良病院
小倉記念病院
近畿大学医学部
静岡市立静岡病院
済生会野江病院
京都岡本記念病院
静岡県立総合病院
親友会島原病院
三菱京都病院
市立島田市民病院
滋賀県立成人病センター
田附興風会北野病院
西神戸医療センター
滋賀医科大学
彦根市立病院
大津赤十字病院
杉田玄白記念公立小浜病院
国立病院機構京都医療センター
関西電力病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-17-1128/_article/-char/en
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-17-1128/_article/-char/en
Number of participants that the trial has enrolled
Results
Background:Venous thromboembolism (VTE) has a long-term risk of recurrence, which can be prevented by anticoagulation therapy.
Methods？and？Results:The COMMAND VTE Registry is a multicenter registry enrolling 3,027 consecutive patients with acute symptomatic VTE between January 2010 and August 2014. The entire cohort was divided into the transient risk (n=855, 28%), unprovoked (n=1,477, 49%), and cancer groups (n=695, 23%). The rate of anticoagulation discontinuation was highest in the cancer group (transient risk: 37.3% vs. unprovoked: 21.4% vs. cancer: 43.5% at 1 year, P<0.001). The cumulative 5-year incidences of recurrent VTE, major bleeding and all-cause death were highest in the cancer group (recurrent VTE: 7.9% vs. 9.3% vs. 17.7%, P<0.001; major bleeding: 9.0% vs. 9.4% vs. 26.6%, P<0.001; and all-cause death: 17.4% vs. 15.3% vs. 73.1%, P<0.001). After discontinuation of anticoagulation therapy, the cumulative 3-year incidence of recurrent VTE was lowest in the transient risk group (transient risk: 6.1% vs. unprovoked: 15.3% vs. cancer: 13.2%, P=0.001). The cumulative 3-year incidence of recurrent VTE beyond 1 year was lower in patients on anticoagulation than in patients off anticoagulation at 1 year in the unprovoked group (on: 3.7% vs. off: 12.2%, P<0.001), but not in the transient risk and cancer groups (respectively, 1.6% vs. 2.5%, P=0.30; 5.6% vs. 8.6%, P=0.44).
Conclusions:The duration of anticoagulation therapy varied widely in discordance with current guideline recommendations. Optimal duration of anticoagulation therapy should be defined according to the risk of recurrent VTE and bleeding as well as death.
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
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 21 | Day |
Other
Other related information
Multicenter historical cohort study
Management information
Registered date
| 2016 | Year | 02 | Month | 22 | Day |
Last modified on
| 2018 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024344
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/10/05 | VTE Registry 研究プロトコール ver1.6.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
