UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021497 |
|---|---|
| Receipt number | R000024794 |
| Scientific Title | Contemporary Management And Outcomes In Patients With Asymptomatic Deep Vein Thrombosis Registry |
| Date of disclosure of the study information | 2016/03/16 |
| Last modified on | 2018/03/25 22:59:36 |
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Basic information
Public title
Contemporary Management And Outcomes In Patients With Asymptomatic Deep Vein Thrombosis Registry
Acronym
Contemporary Management And Outcomes In Patients With Asymptomatic DVT Registry
Scientific Title
Contemporary Management And Outcomes In Patients With Asymptomatic Deep Vein Thrombosis Registry
Scientific Title:Acronym
Contemporary Management And Outcomes In Patients With Asymptomatic DVT Registry
Region
| Japan |
Condition
Condition
Deep Vein Thrombosis
Classification by specialty
| Medicine in general | Cardiology |
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 asymptomatic deep vein thrombosis in the real-world cinical 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
Asymptomatic deep vein thrombosis patients diagnosed by imaging test from January 2010 to September 2015 in Kyoto University Hospital.
Key exclusion criteria
Patients with symptomatic pulmonary embolism.
Target sample size
300
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)
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
| 2016 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28659542
Number of participants that the trial has enrolled
Results
The subjects had concomitant active cancer in 40%, unprovoked DVT in 59%, and distal DVT in 70%. The cumulative 5-year incidences of symptomatic recurrent venous thromboembolism (VTE); major bleeding; and all-cause death were 14.5%, 16.6%, and 34.1%, respectively. Among 232 patients (77%) with prolonged anticoagulant therapy, anticoagulants were discontinued in 48.4% at 1 year. Anticoagulant therapy was associated with a significantly higher incidence of major bleeding compared with the non-anticoagulant group (20.5% vs. 1.5%, P=0.01) with no significant effect on the incidence of VTE. In patients with active cancer, the favorable effect of anticoagulants relative to no anticoagulants for VTE was significant (HR, 0.22; 95% CI: 0.05-0.95).
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 | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 01 | Day |
Other
Other related information
https://www.jstage.jst.go.jp/article/circj/81/12/81_CJ-17-0445/_article/-char/en
Management information
Registered date
| 2016 | Year | 03 | Month | 16 | 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=R000024794
