Perioperative Management of Factor Xa Inhibitors

Atrial Fibrillation Clinical Trial

— PERIXA  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801068
• Other study ID #: PERIXA
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: Eue-Keun Choi, MD, PhD
• Phone: 2-2072-4164
• Email: choiek417[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anticoagulant-induced Bleeding
• Atrial Fibrillation
• Hemorrhage

Intervention

Drug:
• Factor Xa Inhibitor
Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to the predefined protocol.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National university Hostpital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day major bleeding	30-day major bleeding	Within 30 days after the operation/procedure
Secondary	30-day stroke or systemic embolism	30-day stroke or systemic embolism	Within 30 days after the operation/procedure
Secondary	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
Secondary	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