Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-22 @ 9:18 AM
Study NCT ID:
NCT04123067
Status:
TERMINATED
Last Update Posted:
2022-09-15
First Post:
2019-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kbettermann@pennstatehealth.psu.edu', 'phone': '717-531-1803', 'title': 'Dr. Kerstin Bettermann', 'organization': 'Penn State Hershey Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study was terminated early due to lack of funding and Responsible Party relocating to another institution'}}, 'adverseEventsModule': {'timeFrame': '90 days', 'description': 'Placebo Group contains 0 participants because the Responsible Party terminated the study following the enrollment of first study subject, therefore, no serious adverse events, All-cause mortality or other (Not Including Serious) Adverse Events are recorded for the placebo group.', 'eventGroups': [{'id': 'EG000', 'title': 'Pioglitazone Treatment Group', 'description': 'oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPioglitazone 45 mg: 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPlacebo oral tablet: placebo daily for three subsequent days, initiated within 12h of stroke symptom onset', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Neurological Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone Treatment Group', 'description': 'oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPioglitazone 45 mg: 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPlacebo oral tablet: placebo daily for three subsequent days, initiated within 12h of stroke symptom onset'}], 'timeFrame': '90 days post stroke', 'description': 'NIH-Stroke scale (0-42) to assess neurological function with 0 being no deficits and 42 being the worst score', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject that received Placebo was lost to follow up and 90 day outcome data was not collected.'}, {'type': 'PRIMARY', 'title': 'Degree of Disability or Dependence in the Daily Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone Treatment Group', 'description': 'oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPioglitazone 45 mg: 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPlacebo oral tablet: placebo daily for three subsequent days, initiated within 12h of stroke symptom onset'}], 'timeFrame': '90 days post stroke', 'description': 'Measured using the modified Rankin Scale (0-6) to assess neurological function with a score of 0 for no neurological deficits and a maximum of 6 for an expired patient', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject that received Placebo was lost to follow up and 90 day outcome data was not collected.'}, {'type': 'SECONDARY', 'title': 'Concentration of Markers of Neutrophil Activation and Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone Treatment Group', 'description': 'oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPioglitazone 45 mg: 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPlacebo oral tablet: placebo daily for three subsequent days, initiated within 12h of stroke symptom onset'}], 'timeFrame': '24 hours, 48 hours, and 90 days post-stroke', 'description': 'measured in blood by flow cytometry', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject that received Placebo was lost to follow up and data was not collected for any time point'}, {'type': 'SECONDARY', 'title': 'Concentration of Stress Response Markers Including Cortisol, Norepinephrine and Epinephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone Treatment Group', 'description': 'oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPioglitazone 45 mg: 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPlacebo oral tablet: placebo daily for three subsequent days, initiated within 12h of stroke symptom onset'}], 'timeFrame': '24 hours, 48 hours, and 90 days poststroke', 'description': 'measured in blood', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject that received Placebo was lost to follow up and data was not collected for any time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pioglitazone Treatment Group', 'description': 'oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPioglitazone 45 mg: 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPlacebo oral tablet: placebo daily for three subsequent days, initiated within 12h of stroke symptom onset'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pioglitazone Treatment Group', 'description': 'oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPioglitazone 45 mg: 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset\n\nPlacebo oral tablet: placebo daily for three subsequent days, initiated within 12h of stroke symptom onset'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '0', 'groupId': 'BG001'}, {'value': '72', 'spread': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Pioglitazone Group contains 0 participants because the Responsible Party terminated the study following the enrollment of first study subject'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-28', 'size': 1854461, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-06T12:04', 'hasProtocol': True}, {'date': '2021-06-28', 'size': 9976118, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-06T12:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Temporarily suspended due to Pandemic.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2019-10-08', 'resultsFirstSubmitDate': '2022-07-29', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-23', 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurological Status', 'timeFrame': '90 days post stroke', 'description': 'NIH-Stroke scale (0-42) to assess neurological function with 0 being no deficits and 42 being the worst score'}, {'measure': 'Degree of Disability or Dependence in the Daily Activities', 'timeFrame': '90 days post stroke', 'description': 'Measured using the modified Rankin Scale (0-6) to assess neurological function with a score of 0 for no neurological deficits and a maximum of 6 for an expired patient'}], 'secondaryOutcomes': [{'measure': 'Concentration of Markers of Neutrophil Activation and Function', 'timeFrame': '24 hours, 48 hours, and 90 days post-stroke', 'description': 'measured in blood by flow cytometry'}, {'measure': 'Concentration of Stress Response Markers Including Cortisol, Norepinephrine and Epinephrine', 'timeFrame': '24 hours, 48 hours, and 90 days poststroke', 'description': 'measured in blood'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute', 'Hyperglycemia', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'Study objective is to determine whether Pioglitazone (PGZ) can improve clinical outcomes in hyperglycemic acute ischemic stroke (IS). The rationale for the proposed research is to develop an acute intervention that can improve neurological recovery and decrease mortality and morbidity in high-risk diabetic stroke patients.', 'detailedDescription': 'This is a prospective, randomized, double blinded stroke intervention study. Patients presenting with hyperglycemia (blood glucose level = or \\> than 150mg/dl) and acute stroke symptoms within 12h of onset will be randomized to either treatment with PGZ or placebo. Patients will receive oral drug vs placebo once daily for three consecutive days. Blood samples will be obtained at baseline and during the subsequent three days to collect various biomarkers of the stress-immune response following ischemic stroke. Clinical outcomes (NIH-SS and mRS) will be determined at 3 months. Secondary outcome measures are changes in the various blood biomarkers comparing both study groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Stroke Patients ages 21 and over\n2. Blood sugar ≥ 150 mg/dl\n3. Study drug treatment should be initiated within 12 hours after time of symptom onset, if known, or the time last known normal (if time to symptom onset is unknown)\n4. MRI or CT proven ischemic stroke\n5. Initial NIH SS of ≥ 2\n6. Willing and able to provide consent\n\nExclusion Criteria:\n\n1. Known hypersensitivity to PGZ.\n2. Infection at the time of presentation as defined by body temperature \\> 38 degrees C , pneumonia evident on chest X-ray, urinary tract infection (positive tests for nitrites, leukocyte esterase, and bacteria on urine analysis), other acute infection per history or current use of antibiotic or antiviral treatment.\n3. Active malignancy and / or autoimmune disease requiring treatment.\n4. Use of immunomodulatory drugs or chemotherapy.\n5. History of stroke or brain injury within the last 90 days prior to presentation.\n6. Acute illness within the last 30 days which could have affected the white blood cell count.\n7. Known history of clinically significant hypoglycemia.\n8. Patients already taking PGZ.\n9. Active liver disease (ALT and /or AST 2.5 times the upper limit of normal, total bilirubin \\> 1.2 mg/dl).\n10. Acute decompensated heart failure, and/or admission for an acute coronary syndrome, myocardial infarction (MI), cardiac arrest, coronary artery surgery within the past 3 months and patients with New York Heart association Class III and IV heart failure.\n11. History of bladder cancer\n12. Pregnant and nursing women.\n13. Currently incarcerated patients.'}, 'identificationModule': {'nctId': 'NCT04123067', 'briefTitle': 'Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke: Effects on the Stress-Immune Response', 'orgStudyIdInfo': {'id': '00011042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pioglitazone treatment group', 'description': 'oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset', 'interventionNames': ['Drug: Pioglitazone 45 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Pioglitazone 45 mg', 'type': 'DRUG', 'description': '45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset', 'armGroupLabels': ['Pioglitazone treatment group']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'placebo daily for three subsequent days, initiated within 12h of stroke symptom onset', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State College of Medicine', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Kerstin Bettermann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}