RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,897
- 试验地点
- 567
- 主要终点
- Major Bleeding, Annualized Rate of Subjects With Major Bleeds
研究概览
简要总结
The purposes of this study are:
- To evaluate the long-term safety of dabigatran etexilate
- To assess the effect of a knowledge translation intervention on patient outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
dabigatran dose 2
dabigatran low dose twice daily
干预措施: dabigatran dose 2 (Drug)
dabigatran dose 1
dabigatran high dose twice daily
干预措施: dabigatran dose 1 (Drug)
结局指标
主要结局
Major Bleeding, Annualized Rate of Subjects With Major Bleeds
时间窗: up to 43 months
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Major bleeding must have satisfied one or more of the following criteria: * Bleeding associated with a reduction in hemoglobin of at least 20 g/L * Required transfusion of at least 2 units of blood or packed cells * Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal Major bleed were classified as life-threatening if they met one or more of the following criteria: * Reduction in hemoglobin of at least 50 g/L * Transfusion of at least 4 units of blood or packed cells * Symptomatic intracranial bleeding, either subdural or intracerebral * Associated with hypotension requiring use of intravenous inotropic agents * Required surgical intervention to stop bleeding * Resulted in death
次要结局
- Stroke, Annualized Rate of Subjects With Stroke(up to 43 months)
- Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE(up to 43 months)
- Pulmonary Embolism (PE), Annualized Rate of Subjects With PE(up to 43 months)
- Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI(up to 43 months)
- Deep Vein Thrombosis, Annualized Rate of Subjects With DVT(up to 43 months)
- Death, Annualized Rate of Subject Death(up to 43 months)
- Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)(up to 43 months)
- Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death(up to 43 months)
- Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death(up to 43 months)
- Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed(up to 43 months)
- Annualized Rate of Subjects With Minor Bleeds(up to 43 months)
- Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)(up to 43 months)
- Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)(up to 43 months)