Perioperative Management of Factor Xa Inhibitors (PERIXA)

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)

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

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Anticoagulant-induced Bleeding
• Intervention / Treatment: Drug: Factor Xa Inhibitor

Detailed Description

• 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.

• Study Type: Interventional
• Enrollment (Anticipated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eue-Keun Choi, MD, PhD; Phone Number: 82 2-2072-4164; Email: choiek417@gmail.com

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Recruiting
      • Seoul National university Hostpital
      • Contact: Euekeun Choi, M.D. Ph.D.; Phone Number: +82-02-2072-0688; Email: choiek417@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Eue-Keun Choi, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Factor Xa inhibitor; Perioperative management
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Factor Xa Inhibitors
• Other Study ID Numbers: PERIXA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No