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

Wuhan Asia Heart Hospital

Status: Unknown

Conditions: Atrial Fibrillation; Pharmacokinetics and Pharmacodynamics; Oral Anticoagulant

Study type: Observational

Funder types: Other

Identifiers

NCT04684056

2020-YXKY-B010

Details and patient eligibility

About

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.

Enrollment: 1,864 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

1,864 participants in 9 patient groups

Riva-control group

Description:

Routine concentration of Rivaroxaban (Peak)

Riva-High group

Description:

High concentration of Rivaroxaban (Peak)

Riva-Low group

Description:

low concentration of Rivaroxaban (Peak)

Dabi-control group

Description:

Routine concentration of Dabigatran(Peak)

Dabi-High group

Description:

High concentration of Dabigatran(Peak)

Dabi-low group

Description:

low concentration of Dabigatran(Peak)

Edo-control group

Description:

Routine concentration of Edoxaban(Peak)

Edo-high group

Description:

High concentration of Edoxaban(Peak)

Edo-low group

Description:

low concentration of Edoxaban(Peak)