Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-28 @ 7:49 AM
Study NCT ID:
NCT06383650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of 81 vs 325mg of ASA in Treatment of BCVI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020212', 'term': 'Carotid Artery Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020214', 'term': 'Cerebrovascular Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study feasibility', 'timeFrame': '1 year', 'description': 'The feasibility of the study and progression to pilot randomized controlled trial will be determined by whether it is possible to enroll ≥ 70% of eligible patients with BCVI within 90 minutes of diagnosis.'}], 'secondaryOutcomes': [{'measure': 'Incidence of stroke', 'timeFrame': '30 days', 'description': 'The secondary objective will be evaluating the effectiveness of capturing strokes in the study participants during the study period.'}, {'measure': 'Incidence of Bleeding Complications', 'timeFrame': '30 days', 'description': 'The secondary objective will be evaluating the effectiveness of capturing bleeding complications in the study participants during the study period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carotid Artery Injuries', 'Traumatic Injury', 'Vertebral Artery Injury']}, 'descriptionModule': {'briefSummary': 'Blunt cerebrovascular injury (BCVI), or injury to the carotid and vertebral arteries, occurs in 1-3% of blunt traumas, often as a result of injury to the head, neck, or chest. If unrecognized or untreated, BCVI can lead to stroke, which occurs in approximately 20% of untreated patients, potentially causing significant and sometimes permanent disability. Early diagnosis and treatment significantly reduce the risk of stroke.\n\nCurrently, there is wide variation across centers and trauma care providers in treatment strategies for BCVI and the most recent guidelines are unable to make specific recommendations about the optimal agent and/or dose of treatment to reduce the risk of stroke after BCVI while minimizing bleeding complications in patients with multiple traumatic injuries. Recent systematic reviews and meta-analyses evaluating the most common treatment strategies for BCVI have shown similar stroke rates with the use of anticoagulants (usually heparin) vs. antiplatelets (usually aspirin/ASA), however, treatment with antiplatelets was associated with a lower risk of bleeding complications. The optimal dose of ASA for stroke prevention while minimizing bleeding complications is unknown, and more research is required to inform future care.\n\nThis project will investigate two doses of antiplatelet therapy (81 mg daily vs. 325 mg daily aspirin) for BCVI treatment, and will look at the risk of stroke and bleeding complications with each strategy. The goal of the research is to determine whether a large-scale study looking at this question is feasible, which will ultimately help determine the best medical therapy for patients with BCVI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Diagnosed with BCVI via CT angiography (CTA) within 72 hours of injury at a Level I Trauma Center\n\nExclusion Criteria:\n\n1. ≤18 years old\n2. Known Pregnancy\n3. Diagnosis of BCVI made based on imaging from another hospital (non-LTH)\n4. Known pre-existing carotid/vertebral artery disease\n5. Stroke on presentation/before BCVI diagnosis\n6. Determined to require immediate surgical or interventional management of BCVI\n7. Known allergy to ASA\n8. Unable to consent OR absence of a Substitute Decision Maker (SDM)'}, 'identificationModule': {'nctId': 'NCT06383650', 'briefTitle': 'Use of 81 vs 325mg of ASA in Treatment of BCVI', 'organization': {'class': 'OTHER', 'fullName': 'London Health Sciences Centre'}, 'officialTitle': 'Use of 81 vs 325mg of ASA in Treatment of BCVI: A Feasibility RCT', 'orgStudyIdInfo': {'id': '124532'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASA 81mg', 'description': 'Daily study drug (x30 days)', 'interventionNames': ['Drug: Acetylsalicylic Acid']}, {'type': 'EXPERIMENTAL', 'label': 'ASA 325mg', 'description': 'Daily study drug (x30 days)', 'interventionNames': ['Drug: Acetylsalicylic Acid']}], 'interventions': [{'name': 'Acetylsalicylic Acid', 'type': 'DRUG', 'description': 'Patients will undergo CT imaging with the use of contrast for diagnosis of BCVI. Patients will be monitored for feasibility outcomes, as well as the development of stroke and bleeding complications.', 'armGroupLabels': ['ASA 325mg', 'ASA 81mg']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kelly Vogt, MD', 'role': 'CONTACT', 'email': 'kelly.vogt@lhsc.on.ca', 'phone': '619-685-8500', 'phoneExt': '53075'}, {'name': 'Laura Allen, MSc', 'role': 'CONTACT', 'email': 'lauraj.allen@lhsc.on.ca', 'phone': '519-685-8500', 'phoneExt': '54459'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Western University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Trauma Program', 'investigatorFullName': 'Kelly Vogt', 'investigatorAffiliation': 'London Health Sciences Centre'}}}}