Perioperative Management of Factor Xa Inhibitors (PERIXa)

Seoul National University

Status: Active, not recruiting

Conditions: Atrial Fibrillation; Anticoagulant-induced Bleeding

Treatments: Drug: Factor Xa Inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05801068

PERIXa

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,500 participants in 1 patient group

Periprocedural management of FXa-inhibitor group

Experimental group

Description:

Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to predefined protocol.

Treatment:

Drug: Factor Xa Inhibitor