跳至主要内容
临床试验/NCT04684056
NCT04684056Unknown不适用

Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants in Peri-operative Catheter Ablation for Patient With Atrial Fibrillation

Wuhan Asia Heart Hospital0 个研究点目标入组 1,864 人开始时间: 2021年1月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

相似试验