Japanese Study of Warfarin and Aspirin for Prevention of Thrombosis after Valve Replacement

UMIN ID: C000000181

Registered date:13/09/2005

Basic Information

• Health condition(s) or Problem(s) studied: Mitral Valve replacement
• Date of first enrollment: 2003/05/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

warfarin+placebo
warfarin+aspirin

Outcome(s)

• Primary Outcome: cerebral infarction, TIA, infarction of other organs
• Secondary Outcome: 1) death, cerebral infarction, TIA, asymptomatic infarction, 2) Major and minor bleeding

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: National Cardiovascular Center
• Source(s) of Monetary Support: Japan Cardiovascular Research Foundation