Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-06 @ 10:22 AM
Study NCT ID:
NCT07283159
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)', 'timeFrame': '90±7 days', 'description': 'The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome'}], 'secondaryOutcomes': [{'measure': 'proportion of modified Rankin Scale (mRS) 0-2', 'timeFrame': '90±7 days', 'description': 'The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome'}, {'measure': 'ordinal distribution of modified Rankin Scale (mRS)', 'timeFrame': '90±7 days', 'description': 'The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome'}, {'measure': 'change in National Institute of Health stroke scale (NIHSS) score', 'timeFrame': '24 (-6/+12) hours', 'description': 'the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome'}, {'measure': 'change in National Institute of Health stroke scale (NIHSS) score', 'timeFrame': '10±2 days', 'description': 'the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome'}, {'measure': 'occurrence of early neurological improvement (ENI)', 'timeFrame': '24 (-6/+12) hours', 'description': 'ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score'}, {'measure': 'new stroke or other vascular event(s)', 'timeFrame': '90±7 days'}, {'measure': 'symptomatic intracranial hemorrhage (sICH)', 'timeFrame': '24 (-6/+12) hours'}, {'measure': 'major systemic bleeding event', 'timeFrame': '24 (-6/+12) hours'}, {'measure': 'any bleeding event', 'timeFrame': '24 (-6/+12) hours'}, {'measure': 'symptomatic intracranial hemorrhage (sICH)', 'timeFrame': '10±2 days'}, {'measure': 'all-cause mortality', 'timeFrame': '90±7 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'Human urinary kallidinogenase (HUK) is a tissue kallikrein extracted from human urine. Under certain conditions, tissue kallikrein can convert kininogen into kallidin and kinins, thereby promoting vascular endothelial function, and exerting anti-inflammatory and antioxidant effects. Preclinical and clinical studies have demonstrated that HUK can salvage the ischemic penumbra and significantly promote the establishment of collateral circulation. Existing research suggests that the combination of HUK with intravenous alteplase significantly improves neurological function in patients with acute ischemic stroke (AIS) without increasing the risk of hemorrhage. However, whether its combination with tenecteplase can further enhance neurological recovery in patients remains unreported. Based on the above discussion, this study aims to investigate the efficacy and safety of combining tenecteplase with HUK in the treatment of AIS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 year;\n* Acute ischemic stroke confirmed by neuroimaging;\n* The time from last known well to treatment is within 4.5 hours;\n* NIHSS ≥ 6 at randomization;\n* Received intravenous tenecteplase (0.25mg/kg);\n* First stroke onset or past stroke without obvious neurological deficit (mRS≤1);\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Planed for endovascular treatment;\n* Use of Edaravone Injection, Edaravone Dexborneol Injection, Butylphthalide Injection or Capsules after the onset of the current episode；\n* Prior use of ACE inhibitors within a period less than 5 half-lives before the intended administration of Urinary Kallidinogenase for Injection；\n* Pregnancy；\n* Allergy to the investigational drug(s)；\n* Comorbidity with other serious diseases;\n* Participating in other clinical trials within 3 months;\n* Patients not suitable for the study considered by researcher.'}, 'identificationModule': {'nctId': 'NCT07283159', 'briefTitle': 'Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS): a Prospective, Randomized, Double Blinded and Multi-center Study', 'orgStudyIdInfo': {'id': 'Y (2025) 357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': '0.15 PNA units of Urinary Kallidinogenase for Injection + 100ml sodium chloride injection, administered via slow intravenous drip over no less than 50 minutes, once daily', 'interventionNames': ['Drug: Human Urinary Kallidinogenase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Injection Placebo + 100ml sodium chloride injection, administered via slow intravenous drip over no less than 50 minutes, once daily', 'interventionNames': ['Drug: Human Urinary Kallidinogenase']}], 'interventions': [{'name': 'Human Urinary Kallidinogenase', 'type': 'DRUG', 'description': '0.15 PNA units of Human Urinary Kallidinogenase for Injection + 100ml sodium chloride injection', 'armGroupLabels': ['Control group', 'experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110016', 'city': 'Shenyang', 'country': 'China', 'facility': 'Department of Neurology, General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Hui-Sheng Chen', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}