UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021497
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yyamashi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024794

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.