Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 5:46 PM
Study NCT ID:
NCT05000060
Status:
UNKNOWN
Last Update Posted:
2021-10-07
First Post:
2021-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restart TICrH AP Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinded assessment and adjudication of endpoints'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective Randomized Open Label Blinded Endpoint pilot trial of 100 patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'major bleeding', 'timeFrame': '60 days', 'description': 'Recurrent ICrH or other major bleeding defined by BARC3A'}, {'measure': 'Major Vascular Occlusive events', 'timeFrame': 'Baseline (gambles performed pre-randomization)', 'description': "Ischemic stroke; myocardial infarction; mesenteric ischemia; peripheral arterial occlusion; deep vein thrombosis; pulmonary embolism; and carotid, coronary, or peripheral arterial revascularization procedures. Major vascular events defined by the Antithrombotic Trialists' Collaboration"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['restart', 'antiplatelet', 'traumatic intracranial hemorrhage'], 'conditions': ['Traumatic Intracranial Hemorrhage']}, 'descriptionModule': {'briefSummary': 'A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of restarting antiplatelet therapy at 1 week versus 3 weeks after traumatic intracranial hemorrhage with a primary composite endpoint of major bleeding and vascular occlusive events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Acute traumatic intracranial hemorrhage on either mono or dual antiplatelet therapy\n2. History of stroke, vascular stent or coronary or peripheral arterial disease as indication for antiplatelet \\*Restarting dual platelet therapy requires one of the following indications: 1) Acute myocardial infarction in the last year; 2) Coronary stent in the last year; 3) Non-cardioembolic stroke in the last 21 days (with switch to monotherapy at 21 days post stroke) 4) Peripheral arterial stent in the past month (with switch to monotherapy at one month post stent placement).\n\nExclusion Criteria:\n\n1. SDH \\>8 mm maximum width or any midline shift at any time point or more than one SDH\n2. Physician plan to start/restart anticoagulant therapy during trial period\n3. Abbreviated Injury Scale other than head \\>3\n4. Pregnancy\n5. Inability to understand need for adherence to study protocol\n6. Any active pathological bleeding (no acute blood on most recent CT)\n7. Hypersensitivity to drug or other label contraindication\n8. Any bleeding that the investigator deems unsafe to restart at 1 week post injury\n9. Inability to swallow'}, 'identificationModule': {'nctId': 'NCT05000060', 'briefTitle': 'Restart TICrH AP Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'A Prospective Randomized Open-Label Blinded Endpoint (PROBE) Pilot Trial of Early Restarting Antiplatelet Therapy Versus Usual Care After Traumatic Intracranial Hemorrhage.', 'orgStudyIdInfo': {'id': 'UT 101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 week restart', 'description': 'Restart of mono or dual antiplatelet therapy one week post injury in TICrH patients', 'interventionNames': ['Other: Timing/1 week']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 week restart', 'description': "Usual Care for restart of mono or dual antiplatelet therapy after TICrH at clinician's discretion", 'interventionNames': ['Other: Timing/3 weeks']}], 'interventions': [{'name': 'Timing/1 week', 'type': 'OTHER', 'description': 'Time of restart of antiplatelet therapy is one week after injury', 'armGroupLabels': ['1 week restart']}, {'name': 'Timing/3 weeks', 'type': 'OTHER', 'description': 'Time of restart of antiplatelet therapy is left to treating clinician discretion', 'armGroupLabels': ['3 week restart']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Truman J Milling, MD', 'role': 'CONTACT', 'email': 'tjmilling@yahoo.com', 'phone': '15124969742'}, {'name': 'Ashkan J Shoamanesh, MD PhD', 'role': 'CONTACT', 'email': 'ashkan.shoamanesh@phri.ca'}]}, 'ipdSharingStatementModule': {'url': 'https://biolincc.nhlbi.nih.gov/home/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '2 years from study launch', 'ipdSharing': 'YES', 'description': 'Data sharing with NIH BIOLINCC', 'accessCriteria': 'per NIH policy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Director SDMS Stroke Institute', 'investigatorFullName': 'Truman J Milling Jr', 'investigatorAffiliation': 'University of Texas at Austin'}}}}