NCT05801068

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

3.8 years

First QC Date

March 3, 2023

Last Update Submit

January 5, 2025

Conditions

Atrial FibrillationAnticoagulant-induced Bleeding

Keywords

Atrial fibrillationPerioperative managementFactor Xa inhibitor

Outcome Measures

Primary Outcomes (1)

  • 30-day major bleeding

    30-day major bleeding

    Within 30 days after the operation/procedure

Secondary Outcomes (3)

  • 30-day stroke or systemic embolism

    Within 30 days after the operation/procedure

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

    Within 30 days after the operation/procedure

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

    Within 30 days after the operation/procedure

Study Arms (1)

Periprocedural management of FXa-inhibitor group

EXPERIMENTAL

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

Drug: Factor Xa Inhibitor

Interventions

Factor Xa InhibitorDRUG

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

Also known as: PERIXA group
Periprocedural management of FXa-inhibitor group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National university Hostpital

Seoul, Jongno-gu, 03080, South Korea

Location

Related Publications (1)

  • Kwon S, Lee SR, Choi EK, Lee KY, Choi J, Ahn HJ, Oh S, Lip GYH. Perioperative Management in Patients with Atrial Fibrillation Treated with Non-Vitamin K Antagonist Oral Anticoagulants Undergoing Minor Bleeding Risk Procedure: Rationale and Protocol for the PERIXa Study. Vasc Health Risk Manag. 2024 May 17;20:231-244. doi: 10.2147/VHRM.S455530. eCollection 2024.

    PMID: 38774425DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Factor Xa Inhibitors

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AntithrombinsSerine Proteinase InhibitorsProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAnticoagulantsHematologic AgentsTherapeutic Uses

Study Officials

  • Eue-Keun Choi, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2023

First Posted

April 6, 2023

Study Start

August 4, 2020

Primary Completion

May 15, 2024

Study Completion

December 31, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)