Perioperative Management of Factor Xa Inhibitors

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-04

Study Completion Date

2025-12-31

Brief Summary

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This study aims to analyze the safety and effectiveness of the discontinuation/resumption protocol of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are at risk of minor bleeding in actual clinical settings

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Detailed Description

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* Study design This is a multicenter, non-randomized, investigator-initiated prospective cohort study. The study will analyze the bleeding risk and incidence of cardiovascular events according to the discontinuation/resumption of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are prescribed factor Xa inhibitors for stroke prevention and have minor bleeding risk.
* Study population Patients who are over 20 years old, have non-valvular atrial fibrillation, and are taking rivaroxaban, apixaban, or edoxaban (active ingredients), and are facing a procedure defined as having minor bleeding risk.
* Study protocol For patients with non-valvular atrial fibrillation who are prescribed rivaroxaban, apixaban, or edoxaban for stroke prevention and are at risk of minor bleeding, when they visit the prescribing physician (physician A) for consultation and to obtain a medical opinion regarding the discontinuation/resumption of the medication in relation to an invasive procedure, the physician will explain the protocol for discontinuing/resuming the medication and provide a written explanation to ensure that the patient fully understands it.

In addition, the physician in charge of the procedure (physician B) will be notified that the patient has enrolled in this study and will collect information on 1) the type of surgery or procedure performed, and 2) physician B's opinion on the severity of procedure-related bleeding. Thromboembolic and bleeding events will be assessed through patient follow-up 30 days after the procedure.

Conditions

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Atrial Fibrillation Anticoagulant-induced Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Periprocedural management of FXa-inhibitor group

Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to predefined protocol.

Group Type EXPERIMENTAL

Factor Xa Inhibitor

Intervention Type DRUG

Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to the predefined protocol.

Interventions

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Factor Xa Inhibitor

Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to the predefined protocol.

Intervention Type DRUG

Other Intervention Names

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PERIXA group

Eligibility Criteria

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Inclusion Criteria

* Aged \>20 years
* With rivaroxaban, apixaban, or edoxaban
* History of non-valvular atrial fibrillation
* Scheduled minor bleeding risk procedure(s) (dental procedure, cataract/glaucoma surgery, diagnostic GI endoscopy)

Exclusion Criteria

* Pregnancy
* With rivaroxaban or edoxaban at afternoon
* Mental disorder
* Contraindication to rivaroxaban, apixaban, edoxaban
* Moderate or severe valvular heart disease, or with prosthetic heart valves
* With antiplatelet drugs
* History of systemic embolism or ischemic stroke within the last 12 months
* scheduled therapeutic endoscopic procedure(s)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No