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
试验速览
- 阶段
- 不适用
- 入组人数
- 376
- 试验地点
- 3
- 主要终点
- Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Presence of systemic coagulopathies
- •Presence of malignancies needing chemotherapy
- •Inability or refusal to give informed consent
研究组 & 干预措施
Warfarin in elderly with comorbidity
Patients 65 years or older, candidate for therapy with warfarin for non valvular atrial fibrillation or heart valve replacement
干预措施: Warfarin (Drug)
结局指标
主要结局
Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose.
时间窗: 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.
次要结局
- 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)
研究者
Ciro Gallo
Professor of Medical Statistics
University of Campania "Luigi Vanvitelli"