UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010494 |
|---|---|
| Receipt number | R000012269 |
| Scientific Title | Multi-effects of novel oral anticoagurants in nonvalvular atrial fibrillation study |
| Date of disclosure of the study information | 2013/04/15 |
| Last modified on | 2013/04/15 10:02:07 |
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Basic information
Public title
Multi-effects of novel oral anticoagurants
in nonvalvular atrial fibrillation study
Acronym
MELODY
Scientific Title
Multi-effects of novel oral anticoagurants
in nonvalvular atrial fibrillation study
Scientific Title:Acronym
MELODY
Region
| Japan |
Condition
Condition
Nonvalvular Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the pleiotropic effects of dabigatran and rivaroxaban on antiarteriosclerosis
Basic objectives2
Others
Basic objectives -Others
To clarify the effects of dabigatran and rivaroxaban on endothelial function and diabetes
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the antiarteriosclerotic effcts
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of dabigatran
Interventions/Control_2
administration of rivaroxaban
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nonvalvular Atrial Fibrillation
Key exclusion criteria
Valvular Atrial Fibrillation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shusuke Yagi |
Organization
The University of Tokushima Graduate School of Health Biosciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7851
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shusuke Yagi |
Organization
The University of Tokushima Graduate School of Health Biosciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
Homepage URL
Sponsor or person
Institute
Tokushima University hospital
Institute
Department
Personal name
Funding Source
Organization
NA
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
| 2013 | Year | 04 | 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
| 2013 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 15 | 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
| 2013 | Year | 04 | Month | 15 | Day |
Last modified on
| 2013 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012269
