Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 6:53 AM
Study NCT ID:
NCT06211712
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2023-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, double-blind, placebo-controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-01', 'studyFirstSubmitDate': '2023-12-28', 'studyFirstSubmitQcDate': '2024-01-09', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASPECT score evaluated using routine CT', 'timeFrame': 'on day 7 after EVT'}, {'measure': 'Modified Rankin Scale (mRS) score', 'timeFrame': 'on day 90 after EVT'}], 'secondaryOutcomes': [{'measure': 'Barthel index', 'timeFrame': 'on day 10 and 90 after EVT'}, {'measure': 'Percentage of TIC ≥ 2b and mRS ≤2', 'timeFrame': 'on day 90 after EVT'}, {'measure': 'Changes of NIH Stroke Scale(NIHSS) score from baseline', 'timeFrame': 'day 1, 4, 7 and 10 after EVT'}, {'measure': 'Changes of vital signs from baseline', 'timeFrame': 'day 1, 4, 7 and 10 after EVT'}, {'measure': 'Changes of blood inflammatory index and vascular endothelial cell growth index from day 1 after EVT', 'timeFrame': 'day 7 after EVT'}, {'measure': 'MRI and / or DWI examined', 'timeFrame': 'within 10 days to determine the infarct volume'}, {'measure': 'Recurrence rate of ischemic stroke', 'timeFrame': 'within 90 days after EVT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of Human Urinary Kallidinogenase combined with endovascular therapy in acute ischemic stroke (AIS) patients with large vessel occlusion.', 'detailedDescription': 'A prospective, randomized, double-blind, placebo-controlled, multi-center study of Human Urinary Kallidinogenase or Placebo, combined with endovascular therapy for AIS patients with large vessel occlusion.\n\nApproximately 120 eligible subjects will be randomized (1:1) to receive one of the following treatments for 10 days:\n\n* Human Urinary Kallidinogenase combined with endovascular therapy (non-bridged)\n* Placebo combined with endovascular therapy (non-bridged) Primary efficacy of Human Urinary Kallidinogenase will be evaluated at 90±7 days.\n\nThe safety of Human Urinary Kallidinogenase will be evaluated through 90±7 days.\n\nEnd of study evaluation will occur at day 90±7 or premature discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).\n2. Age ≥18 years old.\n3. The mRS score was 0-1 before onset.\n4. ASPECT score of infarction on emergency CT ≥7.\n5. Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery).\n6. Emergency CTP or DWI suggesting infarct core body ≥10 mL and \\<100 mL, and low perfusion brain tissue volume/ infarct core volume\\> 1.2.\n7. Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate).\n\nExclusion Criteria:\n\n1. Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications.\n2. CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.).\n3. Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases.\n4. Taking ACEI antihypertensive drugs regularly and could not stop.\n5. Participant with major surgery or severe trauma in the past 2 weeks.\n6. Poor compliance and cannot fully follow the study protocol.\n7. Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT06211712', 'acronym': 'HEAL', 'briefTitle': 'Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study', 'orgStudyIdInfo': {'id': 'KY2023-707'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Human Urinary Kallidinogenase', 'interventionNames': ['Drug: Experimental: Human Urinary Kallidinogenase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo Comparator: Placebo']}], 'interventions': [{'name': 'Experimental: Human Urinary Kallidinogenase', 'type': 'DRUG', 'description': 'Before the first day of endovascular therapy (non-bridging), dissolve Human Urinary Kallidinogenase in 100 mL 0.9% sodium chloride for intravenous injection, for the next 9 days, once a day for a total of 10 days.', 'armGroupLabels': ['Human Urinary Kallidinogenase']}, {'name': 'Placebo Comparator: Placebo', 'type': 'DRUG', 'description': 'Before the first day of endovascular therapy (non-bridging), dissolve placebo in 100 mL 0.9% sodium chloride for intravenous injection, for the next 9 days, once a day for a total of 10 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Dong, M.D.', 'role': 'CONTACT', 'email': '13701747065@163.com', 'phone': '13701747065'}, {'name': 'Wenjie Cao, M.D.', 'role': 'CONTACT', 'email': 'wenjiecao@fudan.edu.cn', 'phone': '13918206324'}, {'name': 'Yifeng Ling, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qiang Dong, M.D.', 'role': 'CONTACT', 'email': '13701747065@163.com', 'phone': '13701747065'}, {'name': 'Wenjie Cao, M.D.', 'role': 'CONTACT', 'email': 'wenjiecao@fudan.edu.cn', 'phone': '13918206324'}], 'overallOfficials': [{'name': 'Qiang Dong, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}, {'name': 'Wenjie Cao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Stroke Association', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Qiang Dong', 'investigatorAffiliation': 'Huashan Hospital'}}}}