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

December 23, 2020 updated by: Wuhan Asia Heart Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1864

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Qingkun Fan, M.D
  • Phone Number: 86+027-65796640
  • Email: fqk@wahh.com.cn

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Catheter ablation was performed under general anesthesia in patients with NVAF. Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran )were administered peri-operatively to prevent thrombotic events.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of thromboembolic
Time Frame: Ninety days after catheter ablation
Ischemic stroke, Deep vein thrombosis (DVT) or arterial thrombosis of any location after taking DOAC
Ninety days after catheter ablation
Bleeding Incidence
Time Frame: Ninety days after catheter ablation
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
Time Frame
Death from any cause
Time Frame: Ninety days after catheter ablation
Ninety days after catheter ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Asia Heart Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-YXKY-B010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe