Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05801068
Status:
RECRUITING
Last Update Posted:
2023-04-06
First Post:
2023-03-03
Brief Title:
Perioperative Management of Factor Xa Inhibitors
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Effectiveness and Safety of PERIoperative apiXAban Discontinuation in Patients With Atrial Fibrillation Who Undergoing Minor Bleeding Risk Elective Procedure or Surgery A Prospective Multicenter Non-interventional Study PERIXA Study
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERIXA
Brief Summary:
This study aims to analyze the safety and effectiveness of the discontinuationresumption protocol of factor Xa inhibitors before and after invasive proceduressurgeries 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 discontinuationresumption of factor Xa inhibitors before and after invasive proceduressurgeries 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 discontinuationresumption of the medication in relation to an invasive procedure the physician will explain the protocol for discontinuingresuming 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 Bs opinion on the severity of procedure-related bleeding Thromboembolic and bleeding events will be assessed through patient follow-up 30 days after the procedure
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 discontinuationresumption of the medication in relation to an invasive procedure the physician will explain the protocol for discontinuingresuming 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 Bs opinion on the severity of procedure-related bleeding Thromboembolic and bleeding events will be assessed through patient follow-up 30 days after the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None