Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-02 @ 1:50 AM
Study NCT ID:
NCT05169450
Status:
COMPLETED
Last Update Posted:
2021-12-27
First Post:
2021-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D020520', 'term': 'Brain Infarction'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C526713', 'term': 'ginaton'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 998}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2021-12-06', 'studyFirstSubmitQcDate': '2021-12-23', 'lastUpdatePostDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excellent functional outcome', 'timeFrame': '90 days', 'description': 'Excellent functional outcome defined as an Modified Rankin Scale (mRS) score ≤ 1 at 90 days(scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death)'}], 'secondaryOutcomes': [{'measure': 'Neurological deficit amelioration', 'timeFrame': '14 post-randomization days, 90days', 'description': 'neurological deficit amelioration, which was defined as a change in the National Institutes of Health Stroke Scale (NIHSS) score (range = 0-42, with higher scores indicating more severe strokes) from baseline to D14'}, {'measure': 'Patient quality of life', 'timeFrame': '14 post-randomization days, 90days', 'description': 'Patient quality of life, as measured using the EuroQol questionnaire \\[consisting of two parts: EuroQol-5 Dimension(EQ-5D) and EQ visual analog scale (EQ-VAS)\\]. A value of 100 on this scale indicates a perfect score for health, whereas a score of 0 indicates death. The EQ-5D index score is measured on a scale of 0 (death) to 1 (full health).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diterpene Ginkgolides Meglumine Injection', 'acute ischemic stroke', 'effectiveness'], 'conditions': ['Stroke', 'Ischemic Stroke', 'Nervous System Diseases', 'Cerebral Infarction', 'Brain Ischemia', 'Brain Infarction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://druginfo.nlm.nih.gov/drugportal/name/Meglumine', 'label': 'Resource links provided by the National Library of Medicine'}, {'url': 'https://druginfo.nlm.nih.gov/drugportal/name/Ginkgo+biloba', 'label': 'Resource links provided by the National Library of Medicine'}]}, 'descriptionModule': {'briefSummary': 'A randomized positived-controlled study of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) was conducted between7/2013 and 4/2014. The study was designed to test efficacy of DGMI for IS. Post hoc analysis of this trial was conducted to evaluate the efficacy of DGMI in elderly (aged≥65 years) IS patients.', 'detailedDescription': 'To examine the efficacy of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) by age subgroups. The efficacy analysis was a post hoc analysis of data from a large randomized, controlled study was performed in a cohort of 998 IS patients. Patients were pooled and grouped by age (elderly aged ≥ 65 years and non-elderly aged \\< 65 years).Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90days is the primary outcome measure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 35 years of age or older, and gender not limited;\n* Between 2 and 4 weeks onset of ischemic stroke;\n* The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);\n* Understand and voluntarily signed informed consent.\n\nExclusion Criteria:\n\n* Known severe liver or kidney dysfunction;\n* Known allergies for ingredients in the investigational product;\n* Known medical condition likely to limit survival to less than 3 months;\n* Known dementia, mental impairment, or unsuitability for participation as judged by the investigators;\n* Hemorrhage transformation after infarction, or bleeding tendency;\n* Pregnancy or breastfeeding;\n* Known lower extremity venous thrombosis;\n* Having participated in others clinical trial within 1 month before randomization.'}, 'identificationModule': {'nctId': 'NCT05169450', 'briefTitle': 'Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Dongzhimen Hospital, Beijing'}, 'officialTitle': 'Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke: A Post Hoc Analysis of a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TJ2013012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diterpene ginkgolides meglumine injection', 'description': 'The intervention group received daily single infusions of 25 mg diterpene ginkgolides meglumine injection (DGMI) diluted with 250 ml of 0.9% sodium chloride injection for 14 days.', 'interventionNames': ['Drug: Diterpene ginkgolides meglumine injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ginaton', 'description': 'The control group received once or twice a day infusion of 35-60mg Ginaton diluted with 250 ml of 0.9% sodium chloride injection for 14 days.', 'interventionNames': ['Drug: Ginaton']}], 'interventions': [{'name': 'Diterpene ginkgolides meglumine injection', 'type': 'DRUG', 'otherNames': ['Ginkgolides Diterpene Lactone Meglumine Injection'], 'description': 'Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care.', 'armGroupLabels': ['Diterpene ginkgolides meglumine injection']}, {'name': 'Ginaton', 'type': 'DRUG', 'description': 'Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.', 'armGroupLabels': ['Ginaton']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100700', 'city': 'Beijing', 'country': 'China', 'facility': 'Dongzhimen Hospital, Beijing University of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dongzhimen Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ying Gao', 'investigatorAffiliation': 'Dongzhimen Hospital, Beijing'}}}}