UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032996
Receipt No. R000037522
Scientific Title Interventional study on the reduction of thrombus using rivaroxaban for deep vein thrombosis and pulmonary thromboembolism
Date of disclosure of the study information 2018/06/15
Last modified on 2018/06/14

* 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 Interventional study on the reduction of thrombus using rivaroxaban for deep vein thrombosis and pulmonary thromboembolism
Acronym Interventional study on the reduction of thrombus using rivaroxaban for deep vein thrombosis and pulmonary thromboembolism
Scientific Title Interventional study on the reduction of thrombus using rivaroxaban for deep vein thrombosis and pulmonary thromboembolism
Scientific Title:Acronym Interventional study on the reduction of thrombus using rivaroxaban for deep vein thrombosis and pulmonary thromboembolism
Region
Japan

Condition
Condition venous thromboembolism
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Quantitatively clarify thrombotic regression effect in clinical use of a novel oral factor Xa inhibitor rivaroxaban in patients with deep vein thrombosis and pulmonary thromboembolism
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the reduction of venous thrombus 1week,3 weeks, 3 months later after start of the treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 contrast CT examination
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patients with acute symptomatic VTE,and patients with asymptomatic VTE who were considered that it is necessary to receive treatment
Key exclusion criteria under18 years old,massive or submassive PTE patients,patients with active bleeding,patients had CCr under 30ml/min
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Hisatake
Organization Toho University Faculty of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan
TEL 0337624151
Email s-hisatake@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Hisatake
Organization Toho University Faculty of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan
TEL 0337624151
Homepage URL
Email s-hisatake@med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

Funding Source
Organization Toho university
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
2018 Year 06 Month 15 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
2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 14 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037522

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.