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

Sponsor

Wuhan Asia Heart Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04684056

Collaborator

Wuhan Asia General Hospital (http://wagh.com.cn) (Other)

1,864

Enrollment

35.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Anticoagulant Atrial Fibrillation Pharmacokinetics and Pharmacodynamics

Study Design

Study Type:

Observational

Anticipated Enrollment :

1864 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Riva-control group Routine concentration of Rivaroxaban (Peak)
Riva-High group High concentration of Rivaroxaban (Peak)
Riva-Low group low concentration of Rivaroxaban (Peak)
Dabi-control group Routine concentration of Dabigatran(Peak)
Dabi-High group High concentration of Dabigatran(Peak)
Dabi-low group low concentration of Dabigatran(Peak)
Edo-control group Routine concentration of Edoxaban(Peak)
Edo-high group High concentration of Edoxaban(Peak)
Edo-low group low concentration of Edoxaban(Peak)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Death from any cause [Ninety days after catheter ablation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.