Mitral Valve replacement
Conditions
Interventions
warfarin+placebo
warfarin+aspirin
Sponsors
National Cardiovascular Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cerebral infarction, TIA, infarction of other organs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) death, cerebral infarction, TIA, asymptomatic infarction, 2) Major and minor bleeding | — |
Countries
Japan
Outcome results
None listed