Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT06157502
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2023-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C578963', 'term': 'shuxuening'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1380}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2023-11-27', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of mRS score 0 to 1 at 90 days after randomization', 'timeFrame': 'At 90 days after randomization', 'description': 'The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.'}], 'secondaryOutcomes': [{'measure': 'The proportion of mRS score 0 to 2 at 90 days after randomization', 'timeFrame': 'At 90 days after randomization', 'description': 'The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.'}, {'measure': 'The distribution of mRS scores at 90 days after randomization', 'timeFrame': 'At 90 days after randomization', 'description': 'The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.'}, {'measure': 'NIHSS score improvement ≥4 points from baseline at 14 days after randomization or on discharge', 'timeFrame': 'At 14 days after randomization or on discharge', 'description': 'The National Institutes of Health Stroke Scale (NIHSS) score ranges from 0 to 42, with higher scores indicating more severe neurological deficit.'}, {'measure': 'EQ-5D score at 90 days after randomization', 'timeFrame': 'At 90 days after randomization', 'description': 'The European Quality of Life 5-Dimension 3-Level (EQ-5D-3L) includes five dimensions. The sum score on each of the five dimensions ranges from 5 (all domains have level 1) to 15 (all domains have level 3), with higher scores indicating worse health-related quality of life.'}, {'measure': 'The proportion of Barthel index score ≥95 points at 90 days after randomization', 'timeFrame': 'At 90 days after randomization', 'description': 'The Barthel index score ranges from 0 to 100, with higher scores indicating greater independence.'}, {'measure': 'Adverse events within 90 days after randomization', 'timeFrame': 'Within 90 days after randomization'}, {'measure': 'Serious adverse events within 90 days after randomization', 'timeFrame': 'Within 90 days after randomization'}, {'measure': 'Symptomatic intracranial hemorrhage (ECASS-III) within 90 days after randomization', 'timeFrame': 'Within 90 days after randomization'}, {'measure': 'Symptomatic intracranial hemorrhage (SITS-MOST PH2) within 90 days after randomization', 'timeFrame': 'Within 90 days after randomization'}, {'measure': 'All-cause death within 90 days after randomization', 'timeFrame': 'Within 90 days after randomization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic Stroke', 'Intravenous Thrombolysis', 'Neuroprotective Therapy', 'Shuxuening Injection', 'Randomized Controlled Trial'], 'conditions': ['Ischemic Stroke, Acute']}, 'descriptionModule': {'briefSummary': 'Shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of Shuxuening injection in the treatment with intravenous thrombolysis in patients with ischemic stroke.', 'detailedDescription': 'Intravenous thrombolysis with rt-PA within the time window is the most effective drug for acute ischemic stroke, but there are still more than 50% patients with functional disability. Neuroprotective agents can reduce brain cell death after cerebral ischemia by blocking all links of ischemic cascade. Shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy.\n\nThis study is a multicenter, randomized, double-blind, placebo-parallel controlled trial. A total of 1380 patients from 50 centers in China who could be treated within 6 hours of onset and have received or plan to undergo intravenous thrombolytic therapy will be enrolled and randomly assigned, in a 1:1 ratio, to receive Shuxuening injection (20 ml Shuxuening injection + 250 ml 0.9% sodium chloride injection), or to receive Shuxuening injection placebo (20 ml plus 250 ml 0.9% sodium chloride injection); both groups are treated for 10-14 days. The primary efficacy outcome is mRS Score 0 to 1 at 90 days, and the primary safety outcome is adverse events within 90 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older;\n* Diagnosed with acute ischemic stroke;\n* Within 6 hours of onset;\n* Having received or plan to undergo intravenous thrombolytic therapy;\n* NIHISS score of 4 to 25 points at enrollment;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* mRS score greater than 1 point before the onset;\n* Receiving neuroprotective agents, such as edaravone, edaravone dextrocamphorol, butylphthalein, etc. after the onset;\n* Bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), detected by CT/MRI;\n* History of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;\n* Severe hepatic or renal insufficiency (severe hepatic insufficiency refers to the ALT or AST levels above 3 times the upper limit of normal; severe renal insufficiency refers to the creatinine levels above 2 times the upper limit of normal);\n* Allergic to Shuxuening injection or preparations containing ginkgo biloba (ginkgo biloba extract);\n* Women who are pregnant or breastfeeding, and women of childbearing age who have a negative pregnancy test but refuse to take effective contraceptive measures;\n* Participation in another clinical trial with an experimental product during the last 30 days;\n* Other participants deemed unsuitable for participation in this study by the investigator.'}, 'identificationModule': {'nctId': 'NCT06157502', 'briefTitle': 'Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Efficacy and Safety of Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial', 'orgStudyIdInfo': {'id': 'HX-A-2023045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shuxuening injection', 'description': 'Shuxuening Injection + Intravenous Thrombolysis', 'interventionNames': ['Drug: Shuxuening Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo + Intravenous Thrombolysis', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Shuxuening Injection', 'type': 'DRUG', 'description': 'Receiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days', 'armGroupLabels': ['Shuxuening injection']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Receiving 20 ml placebo Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianhua Li', 'role': 'CONTACT'}], 'facility': 'Fangshan District First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Chen', 'role': 'CONTACT'}], 'facility': "Chongqing Nanchuan District People's Hospital", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianwen Han', 'role': 'CONTACT'}], 'facility': "Chongqing Sanbo Chang'an Hospital", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Qianjiang', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoping Xiong', 'role': 'CONTACT'}], 'facility': 'Chongqing Qianjiang Central Hospital', 'geoPoint': {'lat': 29.53284, 'lon': 108.77478}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aiqun Zhao', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Guangdong Pharmaceutical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Heyuan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinzhao He', 'role': 'CONTACT'}], 'facility': "Heyuan People's Hospital", 'geoPoint': {'lat': 23.73333, 'lon': 114.68333}}, {'city': 'Maoming', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiyi Wang', 'role': 'CONTACT'}], 'facility': "Huazhou People's Hospital", 'geoPoint': {'lat': 21.66625, 'lon': 110.91364}}, {'city': 'Meizhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Miaoquan Luo', 'role': 'CONTACT'}], 'facility': 'Meizhou Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 24.28859, 'lon': 116.11768}}, {'city': 'Yunfu', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuanbing Huang', 'role': 'CONTACT'}], 'facility': "Yunfu People's Hospital", 'geoPoint': {'lat': 22.92787, 'lon': 112.03809}}, {'city': 'Zhanjiang', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guanrong Chen', 'role': 'CONTACT'}], 'facility': "Wuchuan People's Hospital", 'geoPoint': {'lat': 21.23391, 'lon': 110.38749}}, {'city': 'Zhongshan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fuyuan Huo', 'role': 'CONTACT'}], 'facility': "Zhongshan People's Hospital", 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}, {'city': 'Zhuhai', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Zhang', 'role': 'CONTACT'}], 'facility': 'The Fifth Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}, {'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xisi Meng', 'role': 'CONTACT'}], 'facility': 'Wuming Hospital Affiliated to Guangxi Medical College', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Zunyi', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojiang Guan', 'role': 'CONTACT'}], 'facility': 'Wuchuan Gelao and Miao Autonomous County Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'city': 'Zunyi', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaohong Fu', 'role': 'CONTACT'}], 'facility': "Zunyi First People's Hospital", 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'city': 'Baoding', 'state': 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'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bosheng Fan', 'role': 'CONTACT'}], 'facility': 'Jiaozuo Coal Industry (Group) Co. Ltd. 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'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yankuo Wang', 'role': 'CONTACT'}], 'facility': "Pingdingshan Second People's Hospital", 'geoPoint': {'lat': 33.73091, 'lon': 113.31554}}, {'city': 'Puyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yungao Pan', 'role': 'CONTACT'}], 'facility': 'Nanle Zhongxing Hospital', 'geoPoint': {'lat': 35.75641, 'lon': 115.04363}}, {'city': 'Qinhuangdao', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guanglei Li', 'role': 'CONTACT'}], 'facility': 'Qinhuangdao Second Hospital'}, {'city': 'Sanmenxia', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Wu', 'role': 'CONTACT'}], 'facility': "Lingbao First People's Hospital", 'geoPoint': {'lat': 34.78081, 'lon': 111.19287}}, {'city': 'Shangqiu', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang Zhang', 'role': 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'geoPoint': {'lat': 34.45, 'lon': 115.65}}, {'city': 'Shangqiu', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoguang Song', 'role': 'CONTACT'}], 'facility': "Xiayi People's Hospital", 'geoPoint': {'lat': 34.45, 'lon': 115.65}}, {'city': 'Shangqiu', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Can Jiang', 'role': 'CONTACT'}], 'facility': 'Yongcheng Central Hospital', 'geoPoint': {'lat': 34.45, 'lon': 115.65}}, {'city': 'Shangqiu', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fengqin Li', 'role': 'CONTACT'}], 'facility': "Yongcheng People's Hospital", 'geoPoint': {'lat': 34.45, 'lon': 115.65}}, {'city': 'Xinxiang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiyi Gou', 'role': 'CONTACT'}], 'facility': "Huixian People's Hospital", 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'city': 'Xinxiang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianhua Zhao', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Xinxiang Medical University', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'city': 'Jingmen', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Zhang', 'role': 'CONTACT'}], 'facility': 'Jingmen Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.03361, 'lon': 112.20472}}, {'city': 'Jingzhou', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Tu', 'role': 'CONTACT'}], 'facility': "Jingzhou First People's Hospital", 'geoPoint': {'lat': 30.35028, 'lon': 112.19028}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Jing', 'role': 'CONTACT'}], 'facility': 'Wuhan Central Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 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