UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000181 |
|---|---|
| Receipt number | 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 16:36:18 |
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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
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
jaswat-office@umin.ac.jp
Sponsor or person
Institute
National Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000177
