Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-05 @ 6:03 PM
Study NCT ID:
NCT05484557
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2022-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}, {'id': 'C000711671', 'term': 'enoxaparin sodium'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2022-07-24', 'studyFirstSubmitQcDate': '2022-08-01', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with venous thromboembolism (VTE)', 'timeFrame': '2 years', 'description': 'deep vein thrombosis or pulmonary embolism'}], 'secondaryOutcomes': [{'measure': 'Number of participants with bleeding events.', 'timeFrame': '6 to 12 weeks', 'description': 'bleeding occurrence (decrease of hemoglobin by at least 1 g/dL) during the medication period.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries', 'Spinal Diseases']}, 'descriptionModule': {'briefSummary': 'Currently, Enoxaparin is the usual prophylactic anticoagulant treatment at the acute and sub-acute phases of spinal cord injury (SCI). Patients at the sub-acute phase of SCI (rehabilitation) will be given either Enoxaparin 40 mg/day (control) or Apixaban 2.5-5 mg twice a day. Apixaban dose will be determined by the treating physician. Treatment will be continued for either 6 or 12 weeks following injury (for AIS grades C-D and A-B respectively).\n\nEndpoints: Venous thromboembolism will be evaluated by D-Dimer test every 2 weeks and an ultrasound doppler at the beginning and the end of the treatment. Bleeding events will be recorded and hematocrit will be monitored every two weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* spinal cord injury (traumatic of not traumatic), Hebrew speaker.\n\nExclusion Criteria:\n\n* contra-indication for anticoagulant treatment\n* concomitant treatment with any other anticoagulant\n* anticoagulant treatment needed for indications other than VTE prevention following spinal cord injury\n* active clinically significant bleeding\n* any lesion or condition considered a significant risk factor for major bleeding.\n* hepatic disease associated with coagulopathy and clinically relevant bleeding risk\n* pregnancy or breast-feeding\n* heart valve related issues\n* galactose intolerance\n* active cancer\n* patients who require thrombolysis or pulmonary embolectomy\n* patients with renal impairment\n* sensitivity to excipients of the medication\n* anti phospholipid syndrome\n* prosthetic heart valve\n* acute ischemic stroke'}, 'identificationModule': {'nctId': 'NCT05484557', 'briefTitle': 'Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Loewenstein Hospital'}, 'officialTitle': 'Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury', 'orgStudyIdInfo': {'id': '0023-20-LOE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study', 'description': 'treatment with Apixaban', 'interventionNames': ['Drug: Apixaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'treatment with Enoxaparin', 'interventionNames': ['Drug: Enoxaparin Sodium']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'description': 'treatment for 6 to 12 weeks', 'armGroupLabels': ['study']}, {'name': 'Enoxaparin Sodium', 'type': 'DRUG', 'description': 'treatment for 6 to 12 weeks', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Raanana', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sara Lipkin', 'role': 'CONTACT'}], 'facility': 'Loewenstein Rehabilitation Hospital', 'geoPoint': {'lat': 32.1836, 'lon': 34.87386}}], 'centralContacts': [{'name': 'Amiram Catz, MD PhD', 'role': 'CONTACT', 'email': 'amiramc@clalit.org.il', 'phone': '972-9-770-9934'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loewenstein Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the spinal department', 'investigatorFullName': 'amiram-catz', 'investigatorAffiliation': 'Loewenstein Hospital'}}}}