UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000181
Receipt No. R000000177
Scientific Title Japanese Study of Warfarin and Aspirin for Prevention of Thrombosis after Valve Replacement
Date of disclosure of the study information 2005/09/13
Last modified on 2005/09/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.