Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-03-02 @ 11:08 PM
Study NCT ID:
NCT02806128
Status:
UNKNOWN
Last Update Posted:
2017-01-06
First Post:
2016-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'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': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the decrease of National Institute of Health stroke scale(NIHSS)', 'timeFrame': '14 Days'}], 'secondaryOutcomes': [{'measure': 'the Barthel Index', 'timeFrame': '90 Days'}, {'measure': 'the Modified Rankin Scale', 'timeFrame': '90 Days'}, {'measure': 'change of the National Institute of Health stroke scale', 'timeFrame': '8 Days'}, {'measure': 'the composite of ischemic vascular events', 'timeFrame': '90 Days', 'description': 'ischemic stroke, MI, or ischemic vascular death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cerebral infarction', 'kallikrein', 'KLK'], 'conditions': ['Cerebral Infarction']}, 'referencesModule': {'references': [{'pmid': '14698996', 'type': 'BACKGROUND', 'citation': 'Xia CF, Yin H, Borlongan CV, Chao L, Chao J. Kallikrein gene transfer protects against ischemic stroke by promoting glial cell migration and inhibiting apoptosis. Hypertension. 2004 Feb;43(2):452-9. doi: 10.1161/01.HYP.0000110905.29389.e5. Epub 2003 Dec 29.'}, {'pmid': '16534002', 'type': 'BACKGROUND', 'citation': 'Xia CF, Smith RS Jr, Shen B, Yang ZR, Borlongan CV, Chao L, Chao J. Postischemic brain injury is exacerbated in mice lacking the kinin B2 receptor. Hypertension. 2006 Apr;47(4):752-61. doi: 10.1161/01.HYP.0000214867.35632.0e. Epub 2006 Mar 13.'}, {'pmid': '16454654', 'type': 'BACKGROUND', 'citation': 'Xia CF, Yin H, Yao YY, Borlongan CV, Chao L, Chao J. Kallikrein protects against ischemic stroke by inhibiting apoptosis and inflammation and promoting angiogenesis and neurogenesis. Hum Gene Ther. 2006 Feb;17(2):206-19. doi: 10.1089/hum.2006.17.206.'}, {'pmid': '20179726', 'type': 'BACKGROUND', 'citation': 'Chen ZB, Huang DQ, Niu FN, Zhang X, Li EG, Xu Y. Human urinary kallidinogenase suppresses cerebral inflammation in experimental stroke and downregulates nuclear factor-kappaB. J Cereb Blood Flow Metab. 2010 Jul;30(7):1356-65. doi: 10.1038/jcbfm.2010.19. Epub 2010 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 to 80 years old;\n2. First time diagnosed or have history of acute anterior circulation cerebral infarction without serious sequelae (mRS = 0-2);\n3. Acute anterior circulation cerebral infarction with large artery atherosclerotic etiology;\n4. Ability to randomize within 48 h of time last known free of new ischemic symptoms.\n5. National Institute of Health stroke scale(NIHSS) ranges from 7 to 22;\n6. signed written informed consent.\n\nExclusion Criteria:\n\n1. Cerebral CT shows cerebral hemorrhage disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.;\n2. Transient ischemic attack;\n3. Serious disturbance of consciousness: Glasgow Coma ScaleGCS（GCS）≤8;\n4. Combined angiotensin-converting enzyme inhibitor(ACEI) less than 5 half-time (according to its instruction), or need to be treated with ACEI;\n5. Past or present suffering from hemorrhagic tendency of the disease;\n6. The investigator in consideration of the other condition that the patients doesn't fit to participate in this clinical study."}, 'identificationModule': {'nctId': 'NCT02806128', 'acronym': 'MAISKFE', 'briefTitle': 'The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship', 'orgStudyIdInfo': {'id': 'MAISKFE1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Injection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days .\n\nPatients need to complete laboratory tests within a specified time.', 'interventionNames': ['Drug: Human Urinary Kallidinogenase for Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Injection of Human Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days .\n\nPatients need to complete laboratory tests within a specified time.', 'interventionNames': ['Drug: Human Urinary Kallidinogenase for Injection']}], 'interventions': [{'name': 'Human Urinary Kallidinogenase for Injection', 'type': 'DRUG', 'otherNames': ['KLK'], 'description': 'Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time', 'armGroupLabels': ['Control group', 'Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110840', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hou Xiaowen, Master', 'role': 'CONTACT', 'email': 'sophia_hxw@163.com', 'phone': '862428897511', 'phoneExt': '15840240196'}], 'facility': 'General hospital of shenyang military region', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Huisheng Chen', 'role': 'CONTACT', 'email': 'chszh@aliyun.com', 'phone': '86-24-28897511'}, {'name': 'zhonghe Zhou', 'role': 'CONTACT', 'email': 'Zhouz.h@tom.com', 'phone': '86-24-28897511'}], 'overallOfficials': [{'name': 'Huisheng Chen', 'role': 'STUDY_CHAIR', 'affiliation': 'General Hospital of Shenyang Military Region'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'After the completion of clinical trials ，Through the article published and upload data 。'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huisheng Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Huisheng Chen', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}