Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke
NCT ID: NCT04491695
Last Updated: 2022-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
420 participants
INTERVENTIONAL
2020-09-12
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tirofiban+Oral antiplatelet therapy
Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.
Tirofiban Hydrochloride
Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 71.5 hours.
Oral antiplatelet
Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.
Oral antiplatelet therapy
Patients will receive oral antiplatelet therapy alone.
Oral antiplatelet
Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.
Interventions
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Tirofiban Hydrochloride
Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 71.5 hours.
Oral antiplatelet
Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. Age 18-80 years old.
4. Informed consent obtained from patient or acceptable patient's surrogate.
Exclusion Criteria
2. Acute ischemic stroke caused by determined or suspected cardioembolism.
3. Acute ischemic stroke caused by other determined caused, including moyamoya disease, artery dissection, arteritis, and etc.
4. Pre-stroke mRS ≥2 or the paralyzed limbs are dyskinesia before stroke.
5. Known hematochezia, gastrointestinal bleeding and any other bleeding.
6. Allergy to tirofiban or its solvents.
7. Patients suffered from severe diseases, including malignant tumor, liver cirrhosis, kidney failure, congestive heart failure, and etc.
8. Gastrointestinal or genitourinary tract bleeding within 1 years.
9. Determined coagulation disorders, platelet dysfunction, or platelet count \<100\*109/L.
10. Major surgical operation or severe trauma within 1 month.
11. Hemorrhagic retinopathy.
12. Chronic hemodialysis.
13. Uncontrolled hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg.
14. Acute pericarditis.
15. Other conditions that determined by the investigators.
18 Years
80 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Ji Xunming,MD,PhD
Professor
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The first Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
Nanyang Second General Hospital
Nanyang, Henan, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The Third People's Hospital of Hubei Province
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Sinapharm North Hospital
Baotou, Inner Mongolia, China
Ordos Central Hospital
Ordos, Inner Mongolia, China
Tongliao City Hosptial
Tongliao, Inner Mongolia, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Beichen Hospital of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
TEDA Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Qingfeng Ma, M.D.
Role: primary
Wenbo Zhao, M.D.
Role: backup
Huishan Du, M.D.
Role: primary
Xiaokun Geng, M.D.
Role: backup
Junqiang Yan, M.D.
Role: primary
Changming Wen, M.D.
Role: primary
Jinhui Qin, M.D.
Role: primary
Yuming Xu
Role: primary
Ziliang Wang, M.D.
Role: primary
Xiaoping Gao, M.D.
Role: primary
Lifei Xing, M.D.
Role: primary
Xiaojun Hao
Role: primary
Yaoming Xu, M.D.
Role: primary
Yu Xu, M.D.
Role: primary
Qinjian Sun, M.D.
Role: primary
Bo Wu, M.D.
Role: primary
Ruixian Wang, M.D.
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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TREND
Identifier Type: -
Identifier Source: org_study_id
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