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

NCT ID: NCT04684056

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1864 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Anticoagulant Atrial Fibrillation Pharmacokinetics and Pharmacodynamics

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Riva-control group

Routine concentration of Rivaroxaban (Peak)

No interventions assigned to this group

Riva-High group

High concentration of Rivaroxaban (Peak)

No interventions assigned to this group

Riva-Low group

low concentration of Rivaroxaban (Peak)

No interventions assigned to this group

Dabi-control group

Routine concentration of Dabigatran(Peak)

No interventions assigned to this group

Dabi-High group

High concentration of Dabigatran(Peak)

No interventions assigned to this group

Dabi-low group

low concentration of Dabigatran(Peak)

No interventions assigned to this group

Edo-control group

Routine concentration of Edoxaban(Peak)

No interventions assigned to this group

Edo-high group

High concentration of Edoxaban(Peak)

No interventions assigned to this group

Edo-low group

low concentration of Edoxaban(Peak)

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Qingkun Fan, M.D

Role: CONTACT

Phone: 86+027-65796640

Email: [email protected]

Litao Zhang, M.D

Role: CONTACT

Phone: 86+027-65796640

Email: [email protected]

Other Identifiers

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2020-YXKY-B010

Identifier Type: -

Identifier Source: org_study_id