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

Atrial Fibrillation Clinical Trial

— LOAF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04684056
• Other study ID #: 2020-YXKY-B010
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2020
• Source: Wuhan Asia Heart Hospital
• Contact: Qingkun Fan, M.D
• Phone: 86+027-65796640
• Email: fqk[@]wahh.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1864
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Oral Anticoagulant
• Pharmacokinetics and Pharmacodynamics

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wuhan Asia Heart Hospital	Wuhan Asia General Hospital (http://wagh.com.cn)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of thromboembolic	Ischemic stroke, Deep vein thrombosis (DVT) or arterial thrombosis of any location after taking DOAC	Ninety days after catheter ablation
Primary	Bleeding Incidence	Any bleeding, Especially gastrointestinal hemorrhage or hemoglobin drop is greater than 20g/L after taking DOAC	Ninety days after catheter ablation
Secondary	Death from any cause		Ninety days after catheter ablation