Valvular atrial fibrillation Prosthetic cardiac valve Atrial fibrillation Warfarin Mechanical prosthetic valve Valvular heart disease Thromboembolism
Conditions
Interventions
Patients with valvular atrial fibrillation or mechanical heary
Prevention
Study group
Sponsors
Health systems research institute
The Heart Association of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with age 18 or more who have one or more of the followings 1. Significant valvular heart disease with atrial fibrillation 2. Mechanical heart valves with or without atrial fibrillation
Exclusion criteria
Exclusion criteria: 1. Recent ischemic stroke up to 3 months 2. Prior prosthetic valve thrombosis or prosthetic valve dysfunction before enrolment 3. Platelets < 100,000/mm3 or established myeloproliferative disorders (essential thrombocythemia, chronic myeloid leukemia, polycythemia vera, agnogenic myeloid metaplasia), hyperviscosity syndrome, chronic disseminated intravascular coagulation (DIC) or antiphospholipid syndrome 4. atrial fibrillation with obvious reversible cause 5. Participate in other clinical trial with undisclosed treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimal INR level 3 years Incidence density; Poisson regression model | — |
Secondary
| Measure | Time frame |
|---|---|
| Pattern of antithrombotic treatment 3 years Prevalence and 95% confidence interval,Factors associated with ischemic stroke 3 years univariate and multivariate logistic regression analysis,Factors associated with major bleeding 3 years univariate and multivariate logistic regression analysis,Economic analysis of consequence and prevention of ischemic stroke 3 years Comparison of QALY | — |
Countries
Thailand
Contacts
Public ContactRungroj Krittayaphong
Siriraj hospital
Outcome results
None listed