CRYptogenic STroke And underLying AF Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 447
- 试验地点
- 55
- 主要终点
- AF Detection Rate Within 6 Months
研究概览
简要总结
The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin for stroke prevention. Physicians can best optimize the use of medicines only if they can precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the time to first AF by 6 months' continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history of AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.
排除标准
- •Known etiology of TIA or stroke.
- •Untreated hyperthyroidism.
- •Myocardial infarction less than 1 month prior to stroke or TIA.
- •Coronary bypass grafting less than 1 month prior to stroke or TIA.
- •Valvular disease requiring immediate surgical intervention.
- •History of AF or atrial flutter.
- •Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral anticoagulation (OAC).
- •Permanent indication for OAC at enrollment.
- •Permanent contra-indication for OAC.
- •Included in another clinical trial.
- •Life expectancy less than 1 year.
- •Indicated for Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system.
- •Not fit, unable or unwilling to follow the required procedures of the protocol.
结局指标
主要结局
AF Detection Rate Within 6 Months
时间窗: 6 months
Percentage of subjects with AF detected within 6 months of follow-up
次要结局
- Use of Oral Anticoagulation (OAC) Drugs(12 months)
- AF Detection Rate Within 12 Months(12 months)
- Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)(12 months)
- Use of Antiarrhythmic Drugs(12 months)
- Health Outcome as Evaluated by EQ-5D Questionnaire(12 months)
- Clinical Disease Burden and Care Pathway(12 months)
- Impact of Patient Assistant Use on AF Diagnosis(Follow-up closure)