Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants in Peri-operative Catheter Ablation for Patient With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 1,864
- 主要终点
- Incidence of thromboembolic
研究概览
简要总结
The incidence of thromboembolic and bleeding event associated with catheter ablation for atrial fibrillation(CAAF) varies from 0.9% to 5% during peri-operative period. Direct oral anticoagulants (DOAC) (such as Rivaroxaban, Dabigatran and Edoxaban) are gradually applied in clinical practice to prevent thrombosis events in patients with AF, but studies have shown that DOAC are also affected by surgery, an invasive procedure, sub-therapeutic, food, renal function and age. However, the pharmacokinetic and pharmacodynamic of DOAC during the peri-operative period of CAAF were lacking in China. The purpose of this study was to evaluate the pharmacokinetics and pharmacokinetics of DOAC in patients with peri-operative atrial fibrillation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with Non-valvular atrial fibrillation(NVAF) undergoing catheter ablation
- •Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran)are administered peri-operatively during catheter ablation.
排除标准
- •Patients who have taken direct oral anticoagulants or warfarin before admission.
- •Cross-replacement of oral anticoagulants, such as taking dabigatran before surgery and replacing Rivaroxaban after surgery.
- •Abnormal coagulation tests (prothrombin time, partial thrombin time, thrombin time, antithrombin activity).
- •Pregnant and lactating women.
结局指标
主要结局
Incidence of thromboembolic
时间窗: Ninety days after catheter ablation
Ischemic stroke, Deep vein thrombosis (DVT) or arterial thrombosis of any location after taking DOAC
Bleeding Incidence
时间窗: Ninety days after catheter ablation
Any bleeding, Especially gastrointestinal hemorrhage or hemoglobin drop is greater than 20g/L after taking DOAC
次要结局
- Death from any cause(Ninety days after catheter ablation)
