Trials Sponsors Conditions Drugs Pricing

Conditions

Anticoagulant-induced Bleeding Atrial Fibrillation

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Seoul National University Hospital
Otherlead

Study Sites (1)

Seoul National university Hostpital

Seoul, Jongno-gu, 03080, South Korea

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 Action

Study Officials

Eue-Keun Choi, MD, PhD
Seoul National University Hospital
PRINCIPAL INVESTIGATOR

Enrollment

2,500 participants (actual enrollment reported by the registry).

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

Actual (reported)

Perioperative Management of Factor Xa Inhibitors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Periprocedural management of FXa-inhibitor group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Periprocedural management of FXa-inhibitor group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations