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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003007
Receipt No. R000003642
Scientific Title Japanese Aortic Stenosis Study-2
Date of disclosure of the study information 2010/04/01
Last modified on 2018/01/15

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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
Email 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
Email ykazuhiro@med.tottori-u.ac.jp

Sponsor
Institute Tottori University
Institute
Department

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
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
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
URL(English) https://upload.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


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