Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-02-25 @ 4:39 PM
Study NCT ID:
NCT01811693
Status:
TERMINATED
Last Update Posted:
2020-10-29
First Post:
2013-03-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Field Administration of Stroke Therapy-Blood Pressure Lowering
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nsanossi@usc.edu', 'phone': '323-442-7793', 'title': 'Nerses Sanossian, MD', 'organization': 'Keck School of Medicine of USC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '90 days after enrollment', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Tier 1', 'description': 'Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal\n\nGlycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Systolic Blood Pressure Change of 8mmHg or More', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Tier 1', 'description': 'Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal\n\nGlycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 15 minutes after treatment', 'description': 'The mean change in blood pressure was measured in the Emergency Department approximately 15 minutes after application of the treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants Experiencing Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Tier 1', 'description': 'Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal\n\nGlycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal'}], 'classes': [{'categories': [{'title': 'SAE', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No SAE', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days after enrollment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants Exhibiting Neurological Deterioration as Indicated by a Two-point or Greater Worsening in the Glasgow Coma Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Tier 1', 'description': 'Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal\n\nGlycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, One hour after enrollment', 'description': 'The Glasgow Coma Scale (GCS) score measures level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants With Systolic Blood Pressure Less Than 120 mm/Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Tier 1', 'description': 'Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal\n\nGlycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after enrollment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Tier 1', 'description': 'Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal\n\nGlycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal'}, {'id': 'FG001', 'title': 'Dose Tier 2', 'description': 'Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal\n\nGlycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal'}, {'id': 'FG002', 'title': 'Dose Tier 3', 'description': 'Glycerly Trinitrate (GTN, Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal plus a single metered dose 0.4mg of sublingual GTN\n\nGlycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal\n\nGlycerly Trinitrate: 0.4 mg sublingual single metered spray'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Tier 1', 'description': 'Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal\n\nGlycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal'}, {'id': 'BG001', 'title': 'Dose Tier 2', 'description': 'Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal\n\nGlycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal'}, {'id': 'BG002', 'title': 'Dose Tier 3', 'description': 'Glycerly Trinitrate (GTN, Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal plus a single metered dose 0.4mg of sublingual GTN\n\nGlycerly Trinitrate: 10mg/24hour (0.4mg/hour) transdermal\n\nGlycerly Trinitrate: 0.4 mg sublingual single metered spray'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The trial was stopped early due to slow enrollment. A pragmatic, low cost study, the lesser frequency of touchpoints between study staff and paramedics seemed to result in paramedics not reliably recalling in time that the study was available to offer to appropriate patients. Due to small sample size, some allocation cells had zero patients.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'The funding period for the study has ended.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2013-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2013-03-06', 'resultsFirstSubmitDate': '2018-04-27', 'studyFirstSubmitQcDate': '2013-03-12', 'lastUpdatePostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-05', 'studyFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participants Experiencing Serious Adverse Events', 'timeFrame': '90 days after enrollment'}, {'measure': 'Participants Exhibiting Neurological Deterioration as Indicated by a Two-point or Greater Worsening in the Glasgow Coma Scale', 'timeFrame': 'Baseline, One hour after enrollment', 'description': 'The Glasgow Coma Scale (GCS) score measures level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired.'}, {'measure': 'Participants With Systolic Blood Pressure Less Than 120 mm/Hg', 'timeFrame': '24 hours after enrollment'}], 'primaryOutcomes': [{'measure': 'Participants With Systolic Blood Pressure Change of 8mmHg or More', 'timeFrame': 'Baseline, 15 minutes after treatment', 'description': 'The mean change in blood pressure was measured in the Emergency Department approximately 15 minutes after application of the treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke', 'Intracerebral Hemorrhage', 'Prehospital', 'Antihypertensive'], 'conditions': ['Intracerebral Hemorrhage', 'Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'This is an open, pilot, dose-escalation study of glyceryl trinitrate (GTN, Nitroglycerin) administered by paramedics in the field within 2 hours of symptom onset to 45 severely hypertensive stroke patients. The primary objective of the study is to evaluate the feasibility, safety, and physiologic efficacy of field-initiated glyceryl trinitrate in achieving modest reduction of blood pressure. Patients with acute stroke will be identified in the field by paramedics who have received training in basic and advanced cardiac life support, stroke recognition, and specific procedures relevant to the proposed study. Physician-investigators will obtain informed consent for each subject for study entry after cellular phone contact with paramedics. Paramedics will initiate antihypertensive treatment by applying transdermal GTN patch in the first two dose-tiers, and administering a single sublingual GTN metered spray followed by application of the transdermal system in the last dose tier. The sites involved in the study will be emergency medical services rescue ambulances and 8 receiving Stroke Center hospitals in Orange County, California, USA.', 'detailedDescription': 'The central aim of this phase 2a study is to identify a regimen of paramedic initiated glyceryl trinitrate antihypertensive therapy in acute stroke patients that is safe, is technically effective in modestly lowering blood pressure, and is optimal to advance to a pivotal trial. The study design is an open-label dose escalation study with three dose tiers,. It is anticipated that the trial will identify the most promising prehospital GTN regimen to advance to a pivotal, placebo-controlled, phase 3 trial.\n\nPrimary Hypothesis: Prehospital glyceryl trinitrate treatment reduces severely hypertensive blood pressure elevation by ED arrival.\n\nThe primary study endpoint to test this hypothesis will be the mean change in SBP from pre-treatment to ED arrival.\n\nSecondary Hypotheses:\n\n1. Prehospital glyceryl trinitrate treatment reduces severely hypertensive blood pressure elevation at early post-arrival timepoints and increases the proportion of patients with target blood pressure at ED arrival and early post-arrival timepoints.\n\n The secondary study endpoints analyzed to test these hypotheses will be: 1) mean change in SBP from pre-treatment to 30 minutes after ED arrival and 60 minutes after ED arrival; and 2) the proportion of patients with SBP \\< 180 mm Hg at ED arrival, 30, and 60 minutes after arrival.\n2. Prehospital initiation of glyceryl trinitrate in the first 2 hours for severely hypertensive patients with stroke is feasible and safe.\n\nSafety of GTN in the first 2 hours for severely hypertensive stroke patients will be assessed by analysis of serious adverse events, neurologic change, and mortality. We hypothesize that initiation of treatment of the patients in the field will be associated with a favorable side effect profile and without severe blood pressure lowering to les than 120 mm Hg systolic.\n\nSuccessful completion of the study will demonstrate feasibility to recruit hypertensive stroke participants and initiate GTN therapy in the field by paramedics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Suspected stroke identified with Los Angeles Prehospital Stroke Screen\n2. Age 40-80, inclusive\n3. Last known well time within 2 hours of treatment initiation\n4. Deficit present for \\> 15 minutes\n5. Systolic blood pressure ≥180\n\nExclusion Criteria:\n\n1. Coma\n2. Rapidly improving neurologic deficit\n3. Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations\n4. Severe respiratory distress (O2 sat \\< 90% or respiratory rate \\< 12 or \\> 24)\n5. Major head trauma in the last 24 hours\n6. Recent stroke within prior 30 days\n7. Use of erectile dysfunction therapies in the previous 12 hours\n8. Use of type V phosphodiesterase inhibitors\n9. Patient unable to give informed consent and no available legally authorized representative (LAR) to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01811693', 'acronym': 'FAST-BP', 'briefTitle': 'Field Administration of Stroke Therapy-Blood Pressure Lowering', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'The Field Administration of Stroke Therapy-Blood Pressure Lowering Pilot Trial', 'orgStudyIdInfo': {'id': 'FBP001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Tier 1', 'description': 'Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal', 'interventionNames': ['Drug: Glycerly Trinitrate']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Tier 2', 'description': 'Glycerly Trinitrate (Nitroglycerine) 10mg/24hour (0.4mg/hour) transdermal', 'interventionNames': ['Drug: Glycerly Trinitrate']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Tier 3', 'description': 'Glycerly Trinitrate (GTN, Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal plus a single metered dose 0.4mg of sublingual GTN', 'interventionNames': ['Drug: Glycerly Trinitrate']}], 'interventions': [{'name': 'Glycerly Trinitrate', 'type': 'DRUG', 'otherNames': ['Nitroglycerine', 'GTN'], 'description': '5mg/24hour (0.2mg/hour) transdermal', 'armGroupLabels': ['Dose Tier 1']}, {'name': 'Glycerly Trinitrate', 'type': 'DRUG', 'otherNames': ['Nitroglycerine', 'GTN'], 'description': '10mg/24hour (0.4mg/hour) transdermal', 'armGroupLabels': ['Dose Tier 2', 'Dose Tier 3']}, {'name': 'Glycerly Trinitrate', 'type': 'DRUG', 'otherNames': ['Nitroglycerine', 'GTN'], 'description': '0.4 mg sublingual single metered spray', 'armGroupLabels': ['Dose Tier 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Los Alamitos Medical Center', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'FAST-MAG Clinical Trial Coordinating Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jeffrey L. Saver', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}