UMIN-CTR Clinical Trial

Basic information
Public title	Japanese Study of Warfarin and Aspirin for Prevention of Thrombosis after Valve Replacement
Acronym	JaSWAT-1
Scientific Title	Japanese Study of Warfarin and Aspirin for Prevention of Thrombosis after Valve Replacement
Scientific Title:Acronym	JaSWAT-1
Region	Japan

Condition
Condition	Mitral Valve replacement
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the incidence of cerebral infarction, TIA and infarction of other organs in patients who underwent MVR and receive anticoagulation therapy in either warfarin alone or warfarin+ aspirin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	cerebral infarction, TIA, infarction of other organs
Key secondary outcomes	1) death, cerebral infarction, TIA, asymptomatic infarction, 2) Major and minor bleeding

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	warfarin+placebo
Interventions/Control_2	warfarin+aspirin
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) mechanical bileaflet mitral valve 2) atrial fibrillation after surgery 3) equal over 20 years old and less than 80 years old 4) Informed consent was obtained 5) patients who visit after the initiation date of the study
Key exclusion criteria	1) ischemic cerebrovascular disease(cerebral infarction,transient ischemic attack) was occurred within 6 months before consent 2) patients whose risk of bleeding was increased such as thrombocytopenia(platelet<100,000mm3), anemia (Hb<10g/dl), anamnesis of intracranial(cerebral,arachnoid),intraocular,myelic,post peritoneal,intra-articular bleeding, GI bleeding within 1 year before consent, GI ulcer within 30 days before consent, High blood Pressure over 180/100mmHg in spite of treatment,hereditary hemorrhagic disease. 3)active infective endocarditis 4)patients who underwent aortic or tricuspid valve replacement 5) patients who had MI within 6 months before consent 6) PTCA or CABG were planned or performed within 6 months before consent 7) malignancy 8) pregnancy 9) recurrent deep venous thrombosis or hereditary thrombosis 10) abnormal CBC or other lab data within 1 month before consent 11) Allergy to aspirin 12) patients who are not suitable for this study cf. re-operation is not contraindication
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ko Bando
Organization	National Cardiovascular Center
Division name	Cardiovascular Surgery
Zip code
Address	5-7-1, Fujishirodai, Suita City, Osaka. 565-8565 Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	National Cardiovascular Center
Division name	JaSWAT office
Zip code
Address
TEL	06-6833-5012
Homepage URL
Email	jaswat-office@umin.ac.jp

Sponsor
Institute	National Cardiovascular Center
Institute
Department

Funding Source
Organization	Japan Cardiovascular Research 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	2005 Year 09 Month 13 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
Date of protocol fixation	2003 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date	2003 Year 05 Month 01 Day
Last follow-up date	2008 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 09 Month 12 Day
Last modified on	2005 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000177

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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