Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:34 PM
Study NCT ID:
NCT07469293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 488}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1', 'timeFrame': 'At Day 90±7 days', 'description': 'Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH)', 'timeFrame': 'up to 48 hours', 'description': 'sICH via criteria adapted from the European Cooperative Acute Stroke Study (ECASS III), defined as any apparent extravascular blood in the brain or within the cranium that is associated with clinical deterioration defined by an NIHSS score increase of four points or more from baseline.'}, {'measure': 'Improvement in NIHSS between baseline and 5-7 days', 'timeFrame': 'at 5-7 days from randomization', 'description': "National Institutes of Health Stroke Scale (NIHSS) is a 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 6 grades with 0 as normal, and there is an allowance for untestable items.Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits"}, {'measure': 'Distribution of Modified Rankin Scale (mRS)', 'timeFrame': 'At Day 90±7 days', 'description': 'Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).'}, {'measure': 'Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2', 'timeFrame': 'At Day 90±7 days', 'description': 'Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).'}, {'measure': 'EQ-5D-5L score', 'timeFrame': 'At Day 90±7 days', 'description': 'Health-related quality of life (the score on the EuroQol Group 5-Dimension 5-Level \\[EQ-5D-5L\\] questionnaire, range,-0.39 to 1, with higher scores indicating better quality of life)'}, {'measure': 'All-cause mortality', 'timeFrame': 'up to 90 days', 'description': 'All-cause mortality at 90 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'DATE-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of tenecteplase combined with standard medications in acute ischemic stroke patients with medium vessel occlusion stroke within 24 hours of onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Acute isolated intracranial medium vessel occlusion (Distal middle cerebral artery M2; M3 and M4 segments of the middle cerebral artery; A1-A4 segments of the anterior cerebral artery; P1-P3 segments of the posterior cerebral artery), confirmed by imaging, with symptom onset to randomization within 24 hours;\n3. NlHSS score ≥ 5\n4. CT scan performed within 24 hours confirming that the ischemic lesion does not involve more than one-third of the territory supplied by the responsible vessel (no evidence of early large infarction)\n5. Patients with premorbid mRS 0 or 1\n6. Written informed consent obtained from the participant or a legally authorized representative\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage confirmed by cranial CT or MRI;\n2. Already received intravenous thrombolysis;\n3. Planned mechanical thrombectomy;\n4. Intraoperative DSA showing vessel rupture, dissection, or contrast agent extravasation;\n5. Pregnant or breastfeeding women;\n6. Allergy to contrast agents or tenecteplase;\n7. Systolic blood pressure \\> 185 mmHg or diastolic blood pressure \\> 110 mmHg, and failure to control with oral antihypertensive medications;\n8. Genetic or acquired bleeding disorders, coagulation factor deficiencies; coagulation dysfunction, INR \\> 1.7, or use of novel oral anticoagulants within 48 hours;\n9. Blood glucose \\< 2.8 mmol/L (50 mg/dL) or \\> 22.2 mmol/L (400 mg/dL), platelet count \\< 100 × 10\\^9/L;\n10. History of bleeding within the past month (gastrointestinal or urinary tract bleeding);\n11. Chronic hemodialysis or severe renal insufficiency (glomerular filtration rate \\< 30 mL/min or serum creatinine \\> 220 μmol/L (2.5 mg/dL));\n12. Severe mental disorders or inability to provide informed consent and comply with follow-up due to dementia;\n13. Concurrent malignant tumors or severe systemic diseases with an expected survival time of less than 90 days;\n14. Intracranial aneurysms or arteriovenous malformations;\n15. Participation in another clinical interventional trial within 30 days prior to randomization or currently participating in another clinical interventional trial;\n16. Occlusions in multiple vascular territories confirmed by CTA/MRA;\n17. Other reasons that the investigator deems inappropriate for participation in the trial'}, 'identificationModule': {'nctId': 'NCT07469293', 'briefTitle': 'Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO)', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial', 'orgStudyIdInfo': {'id': '2025.8.10V1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TNK intra-arterial thrombolysis group', 'description': 'Intra-arterial thrombolysis', 'interventionNames': ['Procedure: Intra-arterial thrombolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard medical therapy group', 'description': 'Only standard medical therapy', 'interventionNames': ['Other: Standard medical treatment']}], 'interventions': [{'name': 'Intra-arterial thrombolysis', 'type': 'PROCEDURE', 'description': 'A standardized microcatheter-based technique was used to administer recombinant TNK-tPA directly into the thrombus. The total dose (0.0625 mg/kg, max 6.25 mg) was delivered in three equal parts: distally, within the mid-clot, and proximally. Angiographic reassessment at 5 minutes determined if a second identical dose was required (max cumulative dose: 0.125 mg/kg). The procedure was continuously monitored and could be terminated immediately for safety concerns.', 'armGroupLabels': ['TNK intra-arterial thrombolysis group']}, {'name': 'Standard medical treatment', 'type': 'OTHER', 'description': 'Standard medical treatment', 'armGroupLabels': ['Standard medical therapy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baise City', 'state': 'Guangxi', 'country': 'China', 'facility': 'Affiliated Hospital of Youjiang Medical University for Nationalities', 'geoPoint': {'lat': 23.89013, 'lon': 106.62684}}, {'city': 'Guilin', 'state': 'Guangxi', 'country': 'China', 'contacts': [{'name': 'Pan Honghua', 'role': 'CONTACT', 'phone': '+86 18978337949'}], 'facility': "Guilin People'S Hospital", 'geoPoint': {'lat': 25.28022, 'lon': 110.29639}}, {'city': 'Qiannan', 'state': 'Guizhou', 'country': 'China', 'contacts': [{'name': 'Jiang Maojun', 'role': 'CONTACT', 'phone': '+86 15185516184'}], 'facility': "The People's Hospital Of QianNan"}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Wu Youlin', 'role': 'CONTACT', 'phone': '+86 18628172896'}], 'facility': "Chongzhou People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Dali', 'state': 'Yunnan', 'country': 'China', 'contacts': [{'name': 'Han Shibo', 'role': 'CONTACT', 'phone': '+86 18908722303'}], 'facility': 'Dali Nationality Autonomous Prefecture Hospital', 'geoPoint': {'lat': 25.58474, 'lon': 100.21229}}, {'city': 'Qujing', 'state': 'Yunnan', 'country': 'China', 'contacts': [{'name': 'Chen Boyu', 'role': 'CONTACT', 'phone': '+86 18064858755'}], 'facility': 'Qujing Central Hospital of Yunnan Province', 'geoPoint': {'lat': 25.48333, 'lon': 103.78333}}, {'city': 'Ankang', 'country': 'China', 'contacts': [{'name': 'Chu Xingjv', 'role': 'CONTACT', 'phone': '+86 15319843133'}], 'facility': 'Ankang Central Hospital', 'geoPoint': {'lat': 32.68, 'lon': 109.01722}}, {'city': 'Anyang', 'country': 'China', 'contacts': [{'name': 'Zhang Jiangang', 'role': 'CONTACT'}], 'facility': "The People'S Hospital of Anyang City", 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'city': 'Changchun', 'country': 'China', 'contacts': [{'name': 'Wang Lesheng', 'role': 'CONTACT', 'phone': '+86 13596227220'}], 'facility': 'Changchun Central Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Chengdu', 'country': 'China', 'contacts': [{'name': 'Wu Changchuan', 'role': 'CONTACT', 'phone': '+86 15388151282'}], 'facility': "Chengdu Second People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chongqing', 'country': 'China', 'contacts': [{'name': 'Ding Chawen', 'role': 'CONTACT', 'phone': '+86 17764830950'}], 'facility': 'Chonggang General Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Chongqing University Fuling Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'country': 'China', 'contacts': [{'name': 'Zhang Zuowen', 'role': 'CONTACT', 'phone': '+86 15823472901'}], 'facility': 'Jiangjin Central Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'country': 'China', 'contacts': [{'name': 'Huang Shuchun', 'role': 'CONTACT', 'phone': '+86 18708533468'}], 'facility': "The Ninth People'S Hospital of Chongqing", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'country': 'China', 'contacts': [{'name': 'Cheng Saiyu', 'role': 'CONTACT', 'phone': '+86 13527598096'}], 'facility': 'The Thrid Affiliated Hospital of CQMU', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'country': 'China', 'contacts': [{'name': 'Cai Tieying', 'role': 'CONTACT', 'phone': '+86 13896311415'}], 'facility': "Yunyang County People'S Hospital", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Fuzhou', 'country': 'China', 'contacts': [{'name': 'Zhao Wenlong', 'role': 'CONTACT', 'phone': '+86 18060893376'}], 'facility': 'The First Affiliated Hospital of Fujian Medicaluniversity', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangyuan', 'country': 'China', 'contacts': [{'name': 'Pu Tianqiang', 'role': 'CONTACT', 'phone': '+86 18227306608'}], 'facility': 'Guangyuan Central Hospital', 'geoPoint': {'lat': 32.44201, 'lon': 105.823}}, {'city': 'Guizhou', 'country': 'China', 'contacts': [{'name': 'Shen Jian', 'role': 'CONTACT', 'phone': '+86 15985527337'}], 'facility': "Qiandongnan Prefecture People's Hospital", 'geoPoint': {'lat': 31.01667, 'lon': 110.58333}}, {'city': 'Huaibei', 'country': 'China', 'contacts': [{'name': 'Ma Xinan', 'role': 'CONTACT', 'phone': '+86 15805619166'}], 'facility': 'Huaibei Miners General Hospital', 'geoPoint': {'lat': 33.97444, 'lon': 116.79167}}, {'city': 'Jianyang', 'country': 'China', 'contacts': [{'name': 'Tang Jie', 'role': 'CONTACT', 'phone': '+86 15123825598'}], 'facility': "The People's Hospital of Jianyang City", 'geoPoint': {'lat': 30.67426, 'lon': 112.19202}}, {'city': 'Jinan', 'country': 'China', 'facility': 'The 960th Hospital of the PLA Joint Logistics Support Force', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Luoyang', 'country': 'China', 'contacts': [{'name': 'Zhao Haojin', 'role': 'CONTACT', 'phone': '+86 18937982836'}], 'facility': "Luoyang Mengjin People's Hospital", 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'city': 'Luoyang', 'country': 'China', 'contacts': [{'name': 'Shen Ruile', 'role': 'CONTACT', 'phone': '+86 15703790088'}], 'facility': 'The First Affiliated Hospital of Henan University of Science and Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'city': 'Luoyang', 'country': 'China', 'contacts': [{'name': 'Zhao Jingjing', 'role': 'CONTACT', 'phone': '+86 18103797861'}], 'facility': "Yiyang County People'S Hospital", 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'city': 'Luzhou', 'country': 'China', 'contacts': [{'name': 'Yuan Zhengzhou', 'role': 'CONTACT', 'phone': '+86 18111209050'}], 'facility': 'The Affiliated Hospital of Southwest Medical University', 'geoPoint': {'lat': 28.8903, 'lon': 105.42575}}, {'city': 'Luzhou', 'country': 'China', 'contacts': [{'name': 'Guo Zhaoyun', 'role': 'CONTACT', 'phone': '+86 13440011005'}], 'facility': 'The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University', 'geoPoint': {'lat': 28.8903, 'lon': 105.42575}}, {'city': 'Mianyang', 'country': 'China', 'contacts': [{'name': 'Luo Jun', 'role': 'CONTACT', 'phone': '+86 13518319060'}], 'facility': 'Mianyang 404 Hospital', 'geoPoint': {'lat': 31.46784, 'lon': 104.68168}}, {'city': 'Mudanjiang', 'country': 'China', 'contacts': [{'name': 'Yu Pengfei', 'role': 'CONTACT', 'phone': '+86 13604609208'}], 'facility': "Mudanjiang First People's Hospital", 'geoPoint': {'lat': 44.54804, 'lon': 129.62594}}, {'city': 'Qingzhen', 'country': 'China', 'contacts': [{'name': 'Fu Hang', 'role': 'CONTACT', 'phone': '+86 15338501820'}], 'facility': 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'Yutian Hospital', 'geoPoint': {'lat': 39.64381, 'lon': 118.18319}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Wuhan Puren Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'country': 'China', 'contacts': [{'name': 'Mei Bin', 'role': 'CONTACT', 'phone': '+86 13037196699'}], 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Xiangyang', 'country': 'China', 'contacts': [{'name': 'Zhou Peiyang', 'role': 'CONTACT', 'phone': '+86 13597491119'}], 'facility': "Xiangyang No.1 People's Hospital", 'geoPoint': {'lat': 32.0422, 'lon': 112.14479}}, {'city': "Ya'an", 'country': 'China', 'contacts': [{'name': 'Wang Jian', 'role': 'CONTACT', 'phone': '+86 13550064528'}], 'facility': "Yaan People's Hospital", 'geoPoint': {'lat': 29.98521, 'lon': 102.999}}, {'city': 'Yichang', 'country': 'China', 'contacts': [{'name': 'Zhou Jinghua', 'role': 'CONTACT', 'phone': '+86 15971663190'}], 'facility': "Yichang Central People's Hospital", 'geoPoint': {'lat': 30.71444, 'lon': 111.28472}}, {'city': 'Zhengzhou', 'country': 'China', 'contacts': [{'name': 'Zhou You', 'role': 'CONTACT', 'phone': '+86 15713891958'}], 'facility': 'Zhengzhou Central Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Zhoukou', 'country': 'China', 'contacts': [{'name': 'Li Shuai', 'role': 'CONTACT', 'phone': '+86 18595389709'}], 'facility': 'Zhoukou Central Hospital', 'geoPoint': {'lat': 33.63333, 'lon': 114.63333}}, {'city': 'Zhumadian', 'country': 'China', 'facility': 'Zhumadian Central Hospital', 'geoPoint': {'lat': 32.97944, 'lon': 114.02944}}, {'city': 'Zhuzhou', 'country': 'China', 'facility': 'Zhuzhou Central Hospital', 'geoPoint': {'lat': 27.83333, 'lon': 113.15}}, {'city': 'Zigong', 'country': 'China', 'facility': "Zigong Third People's Hospital", 'geoPoint': {'lat': 29.34162, 'lon': 104.77689}}], 'centralContacts': [{'name': 'Xianhua Hou', 'role': 'CONTACT', 'email': 'houxianhua@tmmu.edu.cn', 'phone': '86-13594020663'}, {'name': 'Lin Chen', 'role': 'CONTACT', 'email': '406019975@qq.com', 'phone': '86-18602300737'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '6 months after the trial completion.', 'ipdSharing': 'YES', 'description': 'The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.', 'accessCriteria': 'The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhenhua Zhou', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}