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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periprocedural management of FXa-inhibitor group | Experimental | Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to predefined protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Factor Xa Inhibitor | Drug | Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to the predefined protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day major bleeding | 30-day major bleeding | Within 30 days after the operation/procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day stroke or systemic embolism | 30-day stroke or systemic embolism | Within 30 days after the operation/procedure |
| 30-day death from any cause, stroke or systemic embolism | 30-day death from any cause, stroke or systemic embolism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eue-Keun Choi, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National university Hostpital | Seoul | Jongno-gu | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38774425 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D065427 | Factor Xa Inhibitors |
| ID | Term |
|---|---|
| D000991 | Antithrombins |
| D015842 | Serine Proteinase Inhibitors |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
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|
| Within 30 days after the operation/procedure |
| 30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding | 30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding | Within 30 days after the operation/procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D045504 |
| Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000925 | Anticoagulants |
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |