UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Contemporary Management And Outcomes In Patients With Asymptomatic Deep Vein Thrombosis Registry
Title of the study (Brief title)	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	Takeshi Kimura
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Cardiovascular Medicine
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	Yugo Yamashita
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 03 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28659542
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).
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