Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT04491695
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2020-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'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': 'D000077466', 'term': 'Tirofiban'}], 'ancestors': [{'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-16', 'studyFirstSubmitDate': '2020-07-25', 'studyFirstSubmitQcDate': '2020-07-25', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.', 'timeFrame': 'Within 72 hours of intervention.', 'description': 'National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change of the NIHSS', 'timeFrame': '0-30 days of intervention.', 'description': 'National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.'}, {'measure': 'Change of the Scandinavian Stroke Scale', 'timeFrame': '0-30 days of intervention.', 'description': 'Scandinavian Stroke Scale (SSS): stroke symptom severity scale with a range of 0-58. Lower score means more severe stroke symptoms.'}, {'measure': 'The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).', 'timeFrame': '0-90 days.', 'description': 'The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).'}, {'measure': 'Rate of symptomatic intracerebral hemorrhage.', 'timeFrame': '0-90 days'}, {'measure': 'Number of Participants experienced adverse events', 'timeFrame': '0-90 days.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute ischemic stroke', 'Neurological deterioration', 'Stroke progression'], 'conditions': ['Acute Stroke']}, 'referencesModule': {'references': [{'pmid': '31570084', 'type': 'BACKGROUND', 'citation': 'Wu C, Sun C, Wang L, Lian Y, Xie N, Huang S, Zhao W, Ren M, Wu D, Ding J, Song H, Wang Y, Ma Q, Ji X. Low-Dose Tirofiban Treatment Improves Neurological Deterioration Outcome After Intravenous Thrombolysis. Stroke. 2019 Dec;50(12):3481-3487. doi: 10.1161/STROKEAHA.119.026240. Epub 2019 Oct 1.'}, {'pmid': '29127270', 'type': 'RESULT', 'citation': 'Zhao W, Che R, Shang S, Wu C, Li C, Wu L, Chen J, Duan J, Song H, Zhang H, Ling F, Wang Y, Liebeskind D, Feng W, Ji X. Low-Dose Tirofiban Improves Functional Outcome in Acute Ischemic Stroke Patients Treated With Endovascular Thrombectomy. Stroke. 2017 Dec;48(12):3289-3294. doi: 10.1161/STROKEAHA.117.019193. Epub 2017 Nov 10.'}, {'pmid': '39950764', 'type': 'DERIVED', 'citation': 'Wang J, Qiao Y, Li S, Li C, Wu C, Wang P, Yang T, Ji X, Ma Q, Zhao W. Effects of tirofiban in preventing neurological deterioration in acute ischemic stroke with intracranial artery stenosis: A post hoc analysis of the TREND Trial. Eur Stroke J. 2025 Sep;10(3):919-928. doi: 10.1177/23969873251319151. Epub 2025 Feb 14.'}, {'pmid': '39036300', 'type': 'DERIVED', 'citation': 'Wang J, Li S, Li C, Wu C, Song H, Ma Q, Ji X, Zhao W; TREND Investigators. Safety and efficacy of tirofiban in preventing neurological deterioration in acute ischemic stroke (TREND): Protocol for an investigator-initiated, multicenter, prospective, randomized, open-label, masked endpoint trial. Brain Circ. 2024 Jun 26;10(2):168-173. doi: 10.4103/bc.bc_93_23. eCollection 2024 Apr-Jun.'}, {'pmid': '38648030', 'type': 'DERIVED', 'citation': 'Zhao W, Li S, Li C, Wu C, Wang J, Xing L, Wan Y, Qin J, Xu Y, Wang R, Wen C, Wang A, Liu L, Wang J, Song H, Feng W, Ma Q, Ji X; TREND Investigators. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602. doi: 10.1001/jamaneurol.2024.0868.'}]}, 'descriptionModule': {'briefSummary': 'Currently, dual antiplatelet therapy with aspirin and clopidogrel (with loading doses) is widely used for patients with acute ischemic stroke. However, immediate, potent and reversible inhibition of platelet aggregation is not possible. Additionally, more than 5% patients have aspirin resistance and more than 15% patients have clopidogrel resistance. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor (Tirofiban) receptor blocker with fast onset and offset of actions will provide more desired antiplatelet effects in the setting of acute ischemic stroke, especially in patients with high risk of neurological deterioration. This study will measure the anti-platelet effects of Tirofiban in patients with acute ischemic stroke who had high risk of neurological deterioration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Acute ischemic stroke with 24 hours of symptom onset.\n2. NIHSS≥4 and ≤20 points, and the paralyzed limbs is able to actively move the muscle (standardized motor examination rating scale of 2 or much higher).\n3. Age 18-80 years old.\n4. Informed consent obtained from patient or acceptable patient's surrogate.\n\nExclusion Criteria:\n\n1. Treated with intravenous or endovascular thrombectomy for the indexed acute ischemic stroke.\n2. Acute ischemic stroke caused by determined or suspected cardioembolism.\n3. Acute ischemic stroke caused by other determined caused, including moyamoya disease, artery dissection, arteritis, and etc.\n4. Pre-stroke mRS ≥2 or the paralyzed limbs are dyskinesia before stroke.\n5. Known hematochezia, gastrointestinal bleeding and any other bleeding.\n6. Allergy to tirofiban or its solvents.\n7. Patients suffered from severe diseases, including malignant tumor, liver cirrhosis, kidney failure, congestive heart failure, and etc.\n8. Gastrointestinal or genitourinary tract bleeding within 1 years.\n9. Determined coagulation disorders, platelet dysfunction, or platelet count \\<100\\*109/L.\n10. Major surgical operation or severe trauma within 1 month.\n11. Hemorrhagic retinopathy.\n12. Chronic hemodialysis.\n13. Uncontrolled hypertension with systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg.\n14. Acute pericarditis.\n15. Other conditions that determined by the investigators."}, 'identificationModule': {'nctId': 'NCT04491695', 'acronym': 'TREND', 'briefTitle': 'Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Safety and Efficacy of Tirofiban in Preventing Neurological Deterioration of Patients With Acute Ischemic Stroke: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TREND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tirofiban+Oral antiplatelet therapy', 'description': 'Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.', 'interventionNames': ['Drug: Tirofiban Hydrochloride', 'Drug: Oral antiplatelet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral antiplatelet therapy', 'description': 'Patients will receive oral antiplatelet therapy alone.', 'interventionNames': ['Drug: Oral antiplatelet']}], 'interventions': [{'name': 'Tirofiban Hydrochloride', 'type': 'DRUG', 'description': 'Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 71.5 hours.', 'armGroupLabels': ['Tirofiban+Oral antiplatelet therapy']}, {'name': 'Oral antiplatelet', 'type': 'DRUG', 'description': 'Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.', 'armGroupLabels': ['Oral antiplatelet therapy', 'Tirofiban+Oral antiplatelet therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingfeng Ma, M.D.', 'role': 'CONTACT'}, {'name': 'Wenbo Zhao, M.D.', 'role': 'CONTACT'}, {'name': 'Qingfeng Ma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huishan Du, M.D.', 'role': 'CONTACT'}, {'name': 'Xiaokun Geng, M.D.', 'role': 'CONTACT'}], 'facility': 'Beijing Luhe Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Luoyang', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junqiang Yan, M.D.', 'role': 'CONTACT'}], 'facility': 'The first Affiliated Hospital of Henan University of Science and Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'city': 'Nanyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changming Wen, M.D.', 'role': 'CONTACT'}], 'facility': 'Nanyang Central Hospital', 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}, {'city': 'Nanyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinhui Qin, M.D.', 'role': 'CONTACT'}], 'facility': 'Nanyang Second General Hospital', 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuming Xu', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ziliang Wang, M.D.', 'role': 'CONTACT'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "The Third People's Hospital of Hubei Province", 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoping Gao, M.D.', 'role': 'CONTACT'}], 'facility': "Hunan Provincial People's Hospital", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Baotou', 'state': 'Inner Mongolia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lifei Xing, M.D.', 'role': 'CONTACT'}], 'facility': 'Sinapharm North Hospital', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'city': 'Ordos', 'state': 'Inner Mongolia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojun Hao', 'role': 'CONTACT'}], 'facility': 'Ordos Central Hospital', 'geoPoint': {'lat': 39.6086, 'lon': 109.78157}}, {'city': 'Tongliao', 'state': 'Inner Mongolia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yaoming Xu, M.D.', 'role': 'CONTACT'}], 'facility': 'Tongliao City Hosptial', 'geoPoint': {'lat': 43.6125, 'lon': 122.26528}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Xu, M.D.', 'role': 'CONTACT'}], 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Jiangxi Provincial People's Hospital", 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qinjian Sun, M.D.', 'role': 'CONTACT'}], 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Shandong Provincial Qianfoshan Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bo Wu, M.D.', 'role': 'CONTACT'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruixian Wang, M.D.', 'role': 'CONTACT'}], 'facility': 'Beichen Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'TEDA Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Qingfeng Ma, M.D.', 'role': 'CONTACT', 'email': 'm.qingfeng@163.com', 'phone': '010-83199430'}, {'name': 'Wenbo Zhao, M.D.', 'role': 'CONTACT', 'email': 'zhaowb.cool@163.com', 'phone': '86-13120136877'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ji Xunming,MD,PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}