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

Deep Vein Thrombosis

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

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 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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name