NCT04126486已完成4 期
GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals
Bristol-Myers Squibb344 个研究点 分布在 1 个国家目标入组 11,931 人开始时间: 2019年12月17日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11,931
- 试验地点
- 344
- 主要终点
- Incidence of bleeding leading to hospitalization
研究概览
简要总结
The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).
详细描述
This a prospective, randomized study in primary care practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women at least 70 years of age who are new or established participants in the primary care practice
- •Willing to provide consent to participate in the study and to use personal health information to ascertain endpoints from the Center for Medicare & Medicaid Services (CMS) Medicare Claims Database and to access data from health records
- •Health insurance by Medicare Parts A & B (Medicare Fee-for-service)
排除标准
- •Oral anticoagulation (OAC) for any indication at the time of enrollment
- •History of Atrial Fibrillation (AF) or Atrial Flutter (AFL) as documented in the participant's current medical problem list
- •Any condition the investigator considers a contraindication to OAC, e.g., bleeding that required medical attention or severe renal impairment
- •Any condition the investigator considers will prevent compliance with study instructions
- •Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders)
- •History of allergy to adhesive
- •Not able to wear the Zio®XT monitor or not able to apply the monitor by herself/himself or with the help of a caregiver
- •Other protocol-defined inclusion/exclusion criteria could apply
结局指标
主要结局
Incidence of bleeding leading to hospitalization
时间窗: From 2.5 years to 5 years after study start
Incidence of all strokes leading to hospitalization
时间窗: From 2.5 years to 5 years after study start
次要结局
未报告次要终点
研究者
研究点 (344)
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