Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Bleeding complication
研究概览
简要总结
Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with warfarin are well established, the relative risk and benefit of dabigatran in this setting are unknown. The purposes of the study are to assess the efficacy of warfarin versus dabigatran in the prevention of stroke and other systemic embolic complications before and after catheter ablation for AF, and to compare the prevalence of serious bleeding complications with the two OAC agents.
详细描述
- Data from patients collected from 4 US and 1 Canadian medical center
- Retrospective record review of all patients that had undergone catheter ablation of atrial fibrillation during the time period beginning with the initiation of dabigatran therapy for stroke prophylaxis at each center and ending in November 2011.
- Dabigatran study group comprised of all patients that received dabigatran for stroke prophylaxis during the study time period.
- Warfarin comparison group to be selected from all patients that received warfarin for stroke prophylaxis during the identical study time period.
- Warfarin patients will be numbered sequentially
- A subgroup of warfarin patients identical in number to the dabigatran patients at each center will be selected using random number generator.
Patient data sets will be de-identified and compiled
- Master data set to be stored in Excel file
- Statistics to be performed with SAS (Cary, NC)
- Continuous data to be expressed as means ± S.D., compared with unpaired t-tests
- Categorical data will be compared with Fisher's exact test or Chi-square
- Complications including any thromboembolic events or any bleeding events will be recorded and the prevalence compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •All patients undergoing catheter ablation for atrial fibrillation
排除标准
- •none (retrospective trial)
结局指标
主要结局
Bleeding complication
时间窗: 30 days before or after catheter ablation
Any bleeding causing additional intervention, hospitalization or pain and suffering including pericardial tamponade, large hematoma or other bleeding.
Clinical stroke, TIA or systemic embolic complication
时间窗: 30 days before or after catheter ablation
Thromboembolic complication recorded in clinical records.
次要结局
- Any significant complication(30 days before or after catheter ablation)