UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese Aortic Stenosis Study-2
Title of the study (Brief title)	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	Kazuhiro Yamamoto
Organization	Tottori University
Division name	Division of Molecular Medicine and Therapeutics
Address	86 Nishi-cho, Yonago, Japan
TEL	0859-38-6517
Email	ykazuhiro@med.tottori-u.ac.jp

Public contact
Name of contact person	Kazuhiro Yamamoto
Organization	Tottori University
Division name	Division of Molecular Medicine and Therapeutics
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 12 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.thrombosisresearch.com/article/S0049-3848(17)30543-1/fulltext
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).
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