Clinical trial NCT05801068: Perioperative Management of Factor Xa Inhibitors
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Anticoagulant-induced Bleeding
Keywords: Atrial fibrillation
Perioperative management
Factor Xa inhibitor
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 2500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 30-day major bleeding
timeFrame: Within 30 days after the operation/procedure
Secondary outcomes:
measure: 30-day stroke or systemic embolism
timeFrame: Within 30 days after the operation/procedure
measure: 30-day death from any cause, stroke or systemic embolism
timeFrame: Within 30 days after the operation/procedure
measure: 30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding
timeFrame: Within 30 days after the operation/procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National university Hostpital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Eue-Keun Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: