Prospective Validation of IWPC Pharmacogenetic Algorithm for Estimating the Appropriate Initial Dose of Warfarin in Elderly People (65 or Older) With Heart Valves Prostheses or Non Valvular Atrial Fibrillation and Comorbidity
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 376
- Locations
- 3
- Primary Endpoint
- Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose.
Study Overview
Brief Summary
The purpose of this study is to validate the International Warfarin Pharmacogenetics Consortium (IWPC) algorithm in a prospective cohort of elderly people (65 years or older) with heart valves and/or nonvalvular atrial fibrillation (AF) and at least one comorbid condition, and to assess the algorithm's prognostic relevance.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 65 years
- •Patients who initiate warfarin because of non valvular atrial fibrillation or heart valve replacement
- •At least one comorbid condition
- •At least two other drugs regularly assumed over and above warfarin
Exclusion Criteria
- •Presence of systemic coagulopathies
- •Presence of malignancies needing chemotherapy
- •Inability or refusal to give informed consent
Arms & Interventions
Warfarin in elderly with comorbidity
Patients 65 years or older, candidate for therapy with warfarin for non valvular atrial fibrillation or heart valve replacement
Intervention: Warfarin (Drug)
Outcomes
Primary Outcomes
Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose.
Time Frame: up to 12 months
stable warfarin dosing is defined as the mean daily does required to achieve three or more consecutive International Normalized Ratio (INR) measurements within the individual's target range, at the same daily does.
Secondary Outcomes
- number of cardiovascular and cerebrovascular events(4 weeks)
- number of patients with major bleeding events(12 months)
- number of thromboembolic event(12 months)
- average maintenance dose per patient(12 months)
- number of patient reported episodes of minor bleeding events(one year)
- time to therapeutic INR per patient(up to 12 months)
- Percentage of patients for whom the predicted dose is at least 20% higher than the actual dose (overestimation) or at least 20% lower than the actual dose (underestimation).(up to 12 months)
- time to achievement of stable warfarin dosing from initiation(up to 12 months)
- percentage time in the therapeutic INR range(four weeks)
Investigators
Ciro Gallo
Professor of Medical Statistics
University of Campania "Luigi Vanvitelli"