NCT05801068

Perioperative Management of Factor Xa Inhibitors

Effectiveness and Safety of PERIoperative Factor Xa Inhibitor Discontinuation in Patients with Atrial Fibrillation Who Undergoing Minor Bleeding Risk Elective Procedure or Surgery: a Prospective, Multicenter, Noninterventional Study (PERIXa Study)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Atrial Fibrillation
• Anticoagulant-induced Bleeding

Interventions

Type	Name	Description
DRUG	Factor Xa Inhibitor	Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to the predefined protocol.

Timeline

• Start date: 2020-08-04
• Primary completion: 2024-05-15
• Completion: 2025-12-31
• First posted: 2023-04-06
• Last updated: 2025-01-07

Locations

1 site across 1 country: South Korea