UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019910
Receipt number R000022994
Scientific Title An observational study for thrombus regression by anti-coagulation therapy in venous thromboembolism
Date of disclosure of the study information 2015/12/01
Last modified on 2021/11/29 09:22:54

* 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

An observational study for thrombus regression by anti-coagulation therapy in venous thromboembolism

Acronym

VTE thrombus regression by anticoagulants

Scientific Title

An observational study for thrombus regression by anti-coagulation therapy in venous thromboembolism

Scientific Title:Acronym

VTE thrombus regression by anticoagulants

Region

Japan


Condition

Condition

Venous thromboembolism

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison for thrombus regression among anti-coagulants in VTE therapy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Thrombus regression estimated by CT scan or venous echo in 6 months.

Key secondary outcomes

Thrombus regression estimated by CT scan or venous echo in 1 month.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients diagnosed as pulmonary embolism and/or deep vein thrombosis and newly started anticoagulant/

Key exclusion criteria

Acute myocardial infarction, acute heart failure, thrombolysis, active bleeding, contraindication for anticoagulants

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Norimichi
Middle name
Last name Koitabashi

Organization

Gunma University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

371-8511

Address

Showa-machi 3-39-22, Maebashi, Gunma

TEL

027-220-8145

Email

norikoitabashi@gmail.com


Public contact

Name of contact person

1st name Norimichi
Middle name
Last name Koitabashi

Organization

Gunma University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

371-8511

Address

Showa-machi 3-39-15, Maebashi, Gunma

TEL

027-220-8145

Homepage URL


Email

norikoitabashi@gmail.com


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

Gunma University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gunma University Hospital

Address

3-39-22 Showa-machi, Maebashi, Gunma JAPAN

Tel

0272208145

Email

norikoitabashi@gmail.com


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

2015 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Completed

Date of protocol fixation

2015 Year 11 Month 11 Day

Date of IRB

2015 Year 11 Month 28 Day

Anticipated trial start date

2015 Year 11 Month 11 Day

Last follow-up date

2019 Year 10 Month 31 Day

Date of closure to data entry

2019 Year 10 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

So far, 72 patients were enrolled.


Management information

Registered date

2015 Year 11 Month 24 Day

Last modified on

2021 Year 11 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022994


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name