PERIXA: Perioperative Management of Factor Xa Inhibitors

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05801068
• Collaborator: (none)
• Enrollment: 2,500
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 64.9
• Patients Per Site Per Month: 38.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Anticoagulant-induced Bleeding	Drug: Factor Xa Inhibitor	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 2500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: 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)
• Actual Study Start Date: Aug 4, 2020
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 30-day major bleeding [Within 30 days after the operation/procedure]

   30-day major bleeding

Secondary Outcome Measures

1. 30-day stroke or systemic embolism [Within 30 days after the operation/procedure]

   30-day stroke or systemic embolism

2. 30-day death from any cause, stroke or systemic embolism [Within 30 days after the operation/procedure]

   30-day death from any cause, stroke or systemic embolism

3. 30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding [Within 30 days after the operation/procedure]

   30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National university Hostpital	Seoul	Jongno-gu	Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eue-Keun Choi, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT05801068
• Other Study ID Numbers: PERIXA
• First Posted: Apr 6, 2023
• Last Update Posted: Apr 6, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Eue-Keun Choi, Professor, Seoul National University Hospital: Atrial fibrillation; Perioperative management; Factor Xa inhibitor
• Additional relevant MeSH terms: Atrial Fibrillation; Hemorrhage; Factor Xa Inhibitors

Study Results

No Results Posted as of Apr 6, 2023