UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032996 |
|---|---|
| Receipt number | 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 21:22:13 |
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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
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
s-hisatake@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037522
