Anticoagulant-induced Bleeding, Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Perioperative management, Factor Xa inhibitor
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
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 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.
Interventions
DRUGFactor Xa Inhibitor
Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to the predefined protocol.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day major bleeding | Within 30 days after the operation/procedure | 30-day major bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day stroke or systemic embolism | Within 30 days after the operation/procedure | 30-day stroke or systemic embolism |
| 30-day death from any cause, stroke or systemic embolism | Within 30 days after the operation/procedure | 30-day death from any cause, stroke or systemic embolism |
| 30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding | Within 30 days after the operation/procedure | 30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATOREue-Keun Choi, MD, PhD
Seoul National University Hospital
Outcome results
None listed