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临床试验/NCT02461602
NCT02461602已完成不适用

Eliminate Thromboembolism (ELITE): Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients

Duke University21 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2016年2月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (21)

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