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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04684056

Acronym

LOAF

Enrollment

1864

Registered

2020-12-24

Start date

2021-01-01

Completion date

2023-12-31

Last updated

2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Oral Anticoagulant, Pharmacokinetics and Pharmacodynamics

Keywords

Direct oral anticoagulants, pharmacokinetics and pharmacodynamics, Atrial Fibrillation, Rivaroxaban, Dabigatran, Edoxaban, Anti-FXa assays, Dilute thrombin time, Liquid-chromatography tandem mass spectrometry

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Death from any cause	Ninety days after catheter ablation

Contacts

Primary ContactQingkun Fan, M.D

fqk@wahh.com.cn86+027-65796640

Backup ContactLitao Zhang, M.D

zhangleetau@163.com86+027-65796640

Outcome results