Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-02-24 @ 3:51 AM
Study NCT ID:
NCT05801068
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-07
First Post:
2023-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Management of Factor Xa Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065427', 'term': 'Factor Xa Inhibitors'}], 'ancestors': [{'id': 'D000991', 'term': 'Antithrombins'}, {'id': 'D015842', 'term': 'Serine Proteinase Inhibitors'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000925', 'term': 'Anticoagulants'}, {'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-05', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day major bleeding', 'timeFrame': 'Within 30 days after the operation/procedure', 'description': '30-day major bleeding'}], 'secondaryOutcomes': [{'measure': '30-day stroke or systemic embolism', 'timeFrame': 'Within 30 days after the operation/procedure', 'description': '30-day stroke or systemic embolism'}, {'measure': '30-day death from any cause, stroke or systemic embolism', 'timeFrame': 'Within 30 days after the operation/procedure', 'description': '30-day death from any cause, stroke or systemic embolism'}, {'measure': '30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding', 'timeFrame': 'Within 30 days after the operation/procedure', 'description': '30-day composite of major bleeding and clinically relevant non major bleeding (CRNMB), and any bleeding'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Perioperative management', 'Factor Xa inhibitor'], 'conditions': ['Atrial Fibrillation', 'Anticoagulant-induced Bleeding']}, 'referencesModule': {'references': [{'pmid': '38774425', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "* 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.\n* 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.\n* 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\>20 years\n* With rivaroxaban, apixaban, or edoxaban\n* History of non-valvular atrial fibrillation\n* Scheduled minor bleeding risk procedure(s) (dental procedure, cataract/glaucoma surgery, diagnostic GI endoscopy)\n\nExclusion Criteria:\n\n* Pregnancy\n* With rivaroxaban or edoxaban at afternoon\n* Mental disorder\n* Contraindication to rivaroxaban, apixaban, edoxaban\n* Moderate or severe valvular heart disease, or with prosthetic heart valves\n* With antiplatelet drugs\n* History of systemic embolism or ischemic stroke within the last 12 months\n* scheduled therapeutic endoscopic procedure(s)'}, 'identificationModule': {'nctId': 'NCT05801068', 'acronym': 'PERIXa', 'briefTitle': 'Perioperative Management of Factor Xa Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effectiveness and Safety of PERIoperative Factor Xa Inhibitor Discontinuation in Patients with Atrial Fibrillation Who Undergoing Minor Bleeding Risk Elective Procedure or Surgery: a Prospective, Multicenter, Noninterventional Study (PERIXa Study)', 'orgStudyIdInfo': {'id': 'PERIXa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Periprocedural management of FXa-inhibitor group', 'description': 'Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to predefined protocol.', 'interventionNames': ['Drug: Factor Xa Inhibitor']}], 'interventions': [{'name': 'Factor Xa Inhibitor', 'type': 'DRUG', 'otherNames': ['PERIXA group'], 'description': 'Hold and resume factor Xa inhibitor during perioperative/periprocedural period according to the predefined protocol.', 'armGroupLabels': ['Periprocedural management of FXa-inhibitor group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Jongno-gu', 'country': 'South Korea', 'facility': 'Seoul National university Hostpital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Eue-Keun Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eue-Keun Choi', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}