UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027351 |
|---|---|
| Receipt number | R000031232 |
| Scientific Title | Quantitative Volumetric Comparison of Pulmonary Thrombus Reduction between Direct Oral Anticoagulant and Vitamin K Antagonist Treatment in Acute Phase of Symptomatic Patients |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2017/05/15 22:09:52 |
* 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
Quantitative Volumetric Comparison of Pulmonary Thrombus Reduction between Direct Oral Anticoagulant and Vitamin K Antagonist Treatment in Acute Phase of Symptomatic Patients
Acronym
Volumetric Comparison of Pulmonary Thrombus Reduction between DOAC and VKA Treatment
Scientific Title
Quantitative Volumetric Comparison of Pulmonary Thrombus Reduction between Direct Oral Anticoagulant and Vitamin K Antagonist Treatment in Acute Phase of Symptomatic Patients
Scientific Title:Acronym
Volumetric Comparison of Pulmonary Thrombus Reduction between DOAC and VKA Treatment
Region
| Japan |
Condition
Condition
Pulmonary thromboembolism
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To directly compare the efficacy of thrombus volume reduction in pulmonary embolism between edoxaban and warfarin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction rate of pulmonary thrombus
Key secondary outcomes
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
Symptomatic patients with pulmonary thromboembolism who were hospitalized in a single cardiovascular institute between February 2015 and December 2016.
Key exclusion criteria
1. Patients with unstable hemodynamics with massive thromboembolism.
2. Patients with active bleeding.
3. Patients with plenty of deep vein thrombus who needed thrombolytic therapy.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Hagiwara |
Organization
Tokyo Women's Medical University
Division name
Cardiology
Zip code
Address
8-1 Kawawacho, Shinjuku-ku, Tokyo
TEL
+81333538111
mhagi@hij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Jujo |
Organization
Tokyo Women's Medical University
Division name
Cardiology
Zip code
Address
8-1 Kawawacho, Shinjuku-ku, Tokyo
TEL
+81333538111
Homepage URL
juken1123@mac.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 05 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | 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
No significant difference in the primary endpoint between the 2 groups.
Management information
Registered date
| 2017 | Year | 05 | Month | 15 | Day |
Last modified on
| 2017 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031232
