NCT04684056

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,864

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

2.7 years

First QC Date

December 21, 2020

Last Update Submit

December 23, 2020

Conditions

Oral AnticoagulantAtrial FibrillationPharmacokinetics and Pharmacodynamics

Keywords

Direct oral anticoagulantspharmacokinetics and pharmacodynamicsAtrial FibrillationRivaroxabanDabigatranEdoxabanAnti-FXa assaysDilute thrombin timeLiquid-chromatography tandem mass spectrometry

Outcome Measures

Primary Outcomes (2)

  • Incidence of thromboembolic

    Ischemic stroke, Deep vein thrombosis (DVT) or arterial thrombosis of any location after taking DOAC

    Ninety days after catheter ablation

  • Bleeding Incidence

    Any bleeding, Especially gastrointestinal hemorrhage or hemoglobin drop is greater than 20g/L after taking DOAC

    Ninety days after catheter ablation

Secondary Outcomes (1)

  • Death from any cause

    Ninety days after catheter ablation

Study Arms (9)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients with Non-valvular atrial fibrillation(NVAF) undergoing catheter ablation
  • Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran)are administered peri-operatively during catheter ablation.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Qingkun Fan, M.D

CONTACT

86+027-65796640fqk@wahh.com.cn

Litao Zhang, M.D

CONTACT

86+027-65796640zhangleetau@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 24, 2020

Study Start

January 1, 2021

Primary Completion

August 31, 2023

Study Completion

December 31, 2023

Last Updated

December 24, 2020

Record last verified: 2020-12