Perioperative Management of Factor Xa Inhibitors

Study Overview
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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

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.

Official Title
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Effectiveness and Safety of PERIoperative apiXAban Discontinuation in Patients With Atrial Fibrillation Who Undergoing Minor Bleeding Risk Elective Procedure or Surgery: A Prospective, Multicenter, Non-interventional Study (PERIXA Study)

Conditions
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Atrial Fibrillation, Anticoagulant-induced Bleeding

Intervention / Treatment
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* Drug: Factor Xa Inhibitor


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periprocedural management of FXa-inhibitor group<br>Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to predefined protocol. | Drug: Factor Xa Inhibitor<br>* Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to the predefined protocol.<br>* Other names: PERIXA group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day major bleeding | 30-day major bleeding | Within 30 days after the operation/procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day stroke or systemic embolism | 30-day stroke or systemic embolism | Within 30 days after the operation/procedure | 
| 30-day death from any cause, stroke or systemic embolism | 30-day death from any cause, stroke or systemic embolism | Within 30 days after the operation/procedure | 
| 30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding | 30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding | Within 30 days after the operation/procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Perioperative management, Factor Xa inhibitor