Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05801068

Perioperative Management of Factor Xa Inhibitors

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National university Hostpital

Seoul, Jongno-gu, 03080, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Factor Xa Inhibitor

Drug

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

Other names: PERIXA group

Primary outcomes

  1. 30-day major bleeding

    Time frame: Within 30 days after the operation/procedure

    30-day major bleeding

Secondary outcomes

  1. 30-day stroke or systemic embolism

    Time frame: Within 30 days after the operation/procedure

    30-day stroke or systemic embolism

  2. 30-day death from any cause, stroke or systemic embolism

    Time frame: 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

    Time frame: Within 30 days after the operation/procedure

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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)

Acronym: PERIXa

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 6, 2023
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.