Laboratory Assessment of the Concentration of Direct Oral Anticoagulants in Patients With Atrial Fibrillation

Study Overview
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Brief Summary
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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.

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

Conditions
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Oral Anticoagulant, Atrial Fibrillation, Pharmacokinetics and Pharmacodynamics

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Non-valvular atrial fibrillation(NVAF) undergoing catheter ablation Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran)are administered peri-operatively during catheter ablation. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Riva-control group<br>Routine concentration of Rivaroxaban (Peak) | |
| Riva-High group<br>High concentration of Rivaroxaban (Peak) | |
| Riva-Low group<br>low concentration of Rivaroxaban (Peak) | |
| Dabi-control group<br>Routine concentration of Dabigatran(Peak) | |
| Dabi-High group<br>High concentration of Dabigatran(Peak) | |
| Dabi-low group<br>low concentration of Dabigatran(Peak) | |
| Edo-control group<br>Routine concentration of Edoxaban(Peak) | |
| Edo-high group<br>High concentration of Edoxaban(Peak) | |
| Edo-low group<br>low concentration of Edoxaban(Peak) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of thromboembolic | Ischemic stroke, Deep vein thrombosis (DVT) or arterial thrombosis of any location after taking DOAC | Ninety days after catheter ablation | 
| Bleeding Incidence | Any bleeding, Especially gastrointestinal hemorrhage or hemoglobin drop is greater than 20g/L after taking DOAC | Ninety days after catheter ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from any cause |  | Ninety days after catheter ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Direct oral anticoagulants, pharmacokinetics and pharmacodynamics, Atrial Fibrillation, Rivaroxaban, Dabigatran, Edoxaban, Anti-FXa assays, Dilute thrombin time, Liquid-chromatography tandem mass spectrometry