Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-30 @ 2:21 PM
Study NCT ID:
NCT04325932
Status:
WITHDRAWN
Last Update Posted:
2020-03-30
First Post:
2017-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020520', 'term': 'Brain Infarction'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D020521', 'term': 'Stroke'}, {'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': 'D020840', 'term': 'Tissue Kallikreins'}], 'ancestors': [{'id': 'D007610', 'term': 'Kallikreins'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D014408', 'term': 'Biomarkers, Tumor'}, {'id': 'D015415', 'term': 'Biomarkers'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2017-10-05', 'studyFirstSubmitQcDate': '2020-03-27', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'rLMC scale of Collateral circulation', 'timeFrame': '2 weeks, 1 month', 'description': 'We use regional leptomeningeal score(rLMC) score to measure collateral circulation.rLMC score is based on scoring pial and lenticulostriate arteries in 6 ASPECTS regions(M1-6) plus anterior cerebral artery region and basal ganglia. Pial arteries in the Sylvian sulcus are scored 0,2, or 4.'}, {'measure': 'NIHSS score', 'timeFrame': '2 weeks, 1month'}, {'measure': 'Hemorrhageic complications', 'timeFrame': '2 weeks, 1 month, 3 months, 6 months', 'description': 'Hemorrhageic complications including intracranial, digestive tract'}, {'measure': 'New stroke or transient ischemic attack(TIA)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intracranial Arteriosclerosis', 'Collateral Circulation', 'Anterior Cerebral Circulation Infarction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Urinary Kallikrein has an additional effect on enhancing collateral circulation in symptomatic intracranial atherosclerotic patients under clopidogrel and aspirin dual antiplatelet therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Acute ischemic stroke or TIA within 72 hours;\n2. Intracranial ICA, MCA M1 segment stenosis (\\>70%)\n\nExclusion Criteria:\n\n1. \\>70% Stenosis in an intracranial artery other than the culprit artery.\n2. \\>50% Stenosis of an extracranial carotid or vertebral artery on the ipsilateral side.\n3. Perforator strokes based on MRI.\n4. Non-atherosclerotic lesion, for example, moyamoya disease, vascular inflammatory disease due to infection, autoimmunity diseases, developmental or genetic abnormalities, for example, fibromuscular dysplasia, sickle-cell anaemia, suspected vasospasm.\n5. Potential cardiac embolism as cause.\n6. Intracranial haemorrhage within 6 weeks.\n7. Concomitant intracranial tumour, aneurysm or arteriovenous malformation.\n8. Known contraindications for heparin, aspirin, clopidogrel or contrast.\n9. Haemoglobin \\<10 g/dL, blood platelet count \\<100 000, international normalisation ratio \\>1.5, or other uncorrectable coagulopathies.Impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl);\n10. A baseline modified Rankin Score of ≥3.\n11. Life expectancy of \\<1 year due to the concomitant illness.\n12. Pregnant or lactating women.\n13. long-term statins users.\n14. History of mental instability or dementia.'}, 'identificationModule': {'nctId': 'NCT04325932', 'briefTitle': 'Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis: a Study Based on Whole-brain CTP', 'orgStudyIdInfo': {'id': 'UK-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Urinary Kallikrein group', 'description': 'Urinary Kallikrein for injection, 0.15PNA IU,qd, for 2 weeks, administered within 96 hours after TIA or acute ischemic stroke, with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy.', 'interventionNames': ['Drug: Urinary Kallikrein']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy.'}], 'interventions': [{'name': 'Urinary Kallikrein', 'type': 'DRUG', 'otherNames': ['Urinary Kallidinogenase'], 'armGroupLabels': ['Urinary Kallikrein group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The second affiliated hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Min Lou, Ph.D,M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'second affiliated hospital of Zhejiang University, school of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}