Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-31 @ 3:26 PM
Study NCT ID:
NCT01800357
Status:
UNKNOWN
Last Update Posted:
2013-02-27
First Post:
2013-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Mildronate for Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-25', 'studyFirstSubmitDate': '2013-02-25', 'studyFirstSubmitQcDate': '2013-02-25', 'lastUpdatePostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the modified Rankin scale', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'NIHSS scores', 'timeFrame': '8 days'}, {'measure': 'NIHSS scores', 'timeFrame': '15 days'}, {'measure': 'the Barthel index', 'timeFrame': '8 days'}, {'measure': 'the Barthel index', 'timeFrame': '15 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['randomized trial', 'acute ischemic stroke', 'mildronate'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke', 'detailedDescription': 'a randomized, double-blind, placebo-controlled phase II multicenter trial is conducted to evaluate the efficacy and safety of mildronate injection in patients with acute ischemic stroke. patients will be randomized to receive a 14-day treatment of placebo or mildronate (500mg/5ml/each).Primary end-point is the modified Rankin scale at 3 monthes. Secondary end-point is the NIHSS scores and the Barthel index at 8 days and 15days. The safety end-point is defined as the incidence of adverse events, the change of Samples for routine laboratory tests and vital signs. Analysis is by intention to treat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5\\~22 on the first stage\n\nExclusion Criteria:\n\n\\- have other intracranial pathologies are pregnant or nursing have significant drug or alcohol misuse have been in a clinical trial in the past 3 months are unlikely to be available for follow-up have been given thrombolytic therapy or medication forbidden by study protocol have a neurological or psychiatric disease'}, 'identificationModule': {'nctId': 'NCT01800357', 'briefTitle': 'Efficacy and Safety of Mildronate for Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Efficacy and Safety of Mildronate for Acute Ischemic Stroke: Study Protocol for a Randomized, Double-blind, Placebo-controlled Phase II Multicenter Trial', 'orgStudyIdInfo': {'id': 'xijing-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mildronate', 'description': 'infusion of mildronate', 'interventionNames': ['Drug: infusion of mildronate', 'Drug: aspirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'infusion of placebo mildronate', 'interventionNames': ['Drug: placebo', 'Drug: aspirin']}], 'interventions': [{'name': 'infusion of mildronate', 'type': 'DRUG', 'description': 'infusion of mildronate(500mg) once a day and for 14 days', 'armGroupLabels': ['mildronate']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'infusion of plabcebo once a day and for 14 days', 'armGroupLabels': ['placebo']}, {'name': 'aspirin', 'type': 'DRUG', 'description': 'infusion of aspirin (100mg) once a day for days', 'armGroupLabels': ['mildronate', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gang Zhao, MD', 'role': 'CONTACT', 'email': 'zhaogang@fmmu.edu.cn', 'phone': '02984775361'}, {'name': 'Yi Zhu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Guang Yun Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'the Department of Neurology , Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Gang Zhao, MD', 'role': 'CONTACT', 'email': 'zhaogang@fmmu.edu.cn', 'phone': '02984775361'}], 'overallOfficials': [{'name': 'Gang Zhao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'the Department of Neurology , Xijing Hospital'}, {'name': 'Yi Zhu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'the Department of Neurology , Xijing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}