Randomized Evaluation of Dabigatran Etexilate Compared to warfarIn in pulmonaRy Vein Ablation: Assessment of an Uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 678
- 试验地点
- 86
- 主要终点
- Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH)
研究概览
简要总结
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study.
Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting.
It is not intended to assess confirmatory hypothesis, this is an exploratory study.
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
- None
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 Etexilate 150mg
Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID)
干预措施: Dabigatran Etexilate 150mg (Drug)
Warfarin
Patients receiving Warfarin to keep International Normalized Ratio (INR) between 2.0 - 3.0
干预措施: Warfarin (Drug)
结局指标
主要结局
Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH)
时间窗: during and up to 2 months post-ablation
Major bleeds were defined according to the ISTH definition of a major bleed, as follows * Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or * Bleeding associated with a reduction in haemoglobin of at least 2 g/dL (1.24 mmol/L), or leading to transfusion of 2 or more units of blood or packed cells. and/or * Fatal bleed These are based on adjudicated data (blinded evaluation) Point estimates for the incidence of ISTH MBEs and their 2-sided 95% confidence intervals (CI), based on the normal approximation of independent binomial distribution without stratification, are presented.
次要结局
- Incidence of the Composite of Stroke, Systemic Embolism, or Transient Ischemic Attack (TIA)(during and up to 2 months post-ablation)
- Incidence of Minor Bleeding Events(during and up to 2 months post-ablation)
- Incidence of ISTH MBE, Stroke, Systemic Embolism, or TIA (Composite Endpoint Combining Safety and Efficacy(during and up to 2 months post-ablation)