UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003007 |
|---|---|
| Receipt number | R000003642 |
| Scientific Title | Japanese Aortic Stenosis Study-2 |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2018/01/15 12:33:46 |
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Basic information
Public title
Japanese Aortic Stenosis Study-2
Acronym
JASS-2
Scientific Title
Japanese Aortic Stenosis Study-2
Scientific Title:Acronym
JASS-2
Region
| Japan |
Condition
Condition
patients with atrial fibrillation and warfarin usage, patients with cardiovascular diseases and without warfarin prescription
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of warfarin on aortic valve calcification, and to clarify medications which effectively inhibit aortic valve calcification induced by warfarin
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
aortic valve calcification
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with atrial fibrillation and warafarin usage, patients with cardiovascular diseases and without warfarin prescription
Key exclusion criteria
no
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yamamoto |
Organization
Tottori University
Division name
Division of Molecular Medicine and Therapeutics
Zip code
Address
86 Nishi-cho, Yonago, Japan
TEL
0859-38-6517
ykazuhiro@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yamamoto |
Organization
Tottori University
Division name
Division of Molecular Medicine and Therapeutics
Zip code
Address
86 Nishi-cho, Yonago, Japan
TEL
0859-38-6517
Homepage URL
ykazuhiro@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.thrombosisresearch.com/article/S0049-3848(17)30543-1/fulltext
Number of participants that the trial has enrolled
Results
Despite higher atherosclerotic risks in the non-warfarin group, 2 or 3 newly calcified leaflets emerged during 4 years in 18.0% of patients in the warfarin group and in 6.9% in the non-warfarin group (p=0.014). Aortic valve area did not significantly change in the non-warfarin group during the follow-up, but tended to decrease in the warfarin group (p=0.057). Non-vitamin K antagonist oral anticoagulant got available in Japan after this study started, and warfarin was discontinued in 15 patients of the warfarin group. The reduction of aortic valve area was significant in the remaining 107 patients on the continuous warfarin treatment (p=0.002).
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
Main results already published
Date of protocol fixation
| 2009 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2010 | Year | 01 | Month | 10 | Day |
Last modified on
| 2018 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003642
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
