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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019910
Receipt No. 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 2018/11/26

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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
Middle name
Last name Norimichi Koitabashi
Organization Gunma University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address Showa-machi 3-39-22, Maebashi, Gunma
TEL 027-220-8145
Email norikoitabashi@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Norimichi Koitabashi
Organization Gunma University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address Showa-machi 3-39-15, Maebashi, Gunma
TEL 027-220-8145
Homepage URL
Email norikoitabashi@gmail.com

Sponsor
Institute Gunma University
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
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
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.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


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