Japanese Study of Warfarin and Aspirin for Prevention of Thrombosis after Valve Replacement
- Conditions
- Mitral Valve replacement
- Registration Number
- JPRN-C000000181
- Lead Sponsor
- ational Cardiovascular Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 200
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cerebral infarction, TIA, infarction of other organs
- Secondary Outcome Measures
Name Time Method 1) death, cerebral infarction, TIA, asymptomatic infarction, 2) Major and minor bleeding