Eliminate Thromboembolism (ELITE): Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 21
- 主要终点
- Change in Warfarin adherence
研究概览
简要总结
ELITE (Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients) is a two year research project to assess warfarin management issues faced by atrial fibrillation (AF) patients in ambulatory settings.
详细描述
ELITE will be a prospective, multicenter observational study of 500 participants to characterize demographics, comorbidities, risk profiles, socioeconomic status, and patient preferences related to anticoagulation management. The primary study endpoint will be warfarin discontinuation without resumption as documented in the medical record. Secondary outcomes of interest include warfarin adherence and factors associated with suboptimal adherence and/or permanent discontinuation. Clinical data, including demographics, medical history, and comorbidities, will be abstracted and entered by site coordinators. An internal survey developed by Duke Clinical Research Institute (DCRI) will be administered to patients during regularly scheduled clinic visits. Survey items will include patient treatment priorities, perceived risk of bleeding and/or stroke, barriers to adherence, and treatment satisfaction. Subjects will complete a survey at baseline and at the followup visit closest to 6 months after enrollment.
This study will provide the foundation for numerous potential future questions about medication adherence and barriers to treatment, such as a survey on physician preferences/ shared decision-making (concordance between physician and patient preferences), followup to capture clinical events, and interventions to improve long-term medication adherence in AF.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older at the time of enrollment
- •Electrocardiographically confirmed AF
- •Able to complete patient-reported outcomes surveys
- •Initiated warfarin therapy in the prior 3 months
- •Ability to adhere to regular clinical visits
- •Ability to sign informed consent
- •Ability to read/comprehend/speak English
排除标准
- •Anticipated life expectancy less than six months (as determined by the site investigator)
- •Transient AF secondary to a reversible condition (hyperthyroidism, pulmonary embolism, post-cardiothoracic surgery)
- •Recent Deep Venous Thrombosis(DVT) or Pulmonary Embolism (PE) (within 6 months)
- •Participation in a randomized trial of anticoagulation for AF
- •Use of a home international normalized ratio (INR) monitoring system
结局指标
主要结局
Change in Warfarin adherence
时间窗: Baseline and 6 months
Reason(s) for Warfarin discontinuation
时间窗: 6 months
次要结局
- Frequency of bleeding events(Baseline and 6 months)
- Frequency of hospitalizations(Baseline and 6 months)
- Change in INR values(Baseline and 6 months)
