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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirofiban+Oral antiplatelet therapy | Experimental | Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter. |
|
| Oral antiplatelet therapy | Active Comparator | Patients will receive oral antiplatelet therapy alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirofiban Hydrochloride | Drug | Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 71.5 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS. | National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms. | Within 72 hours of intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the NIHSS | National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms. | 0-30 days of intervention. |
| Change of the Scandinavian Stroke Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingfeng Ma, M.D. | Contact | 010-83199430 | m.qingfeng@163.com | |
| Wenbo Zhao, M.D. | Contact | 86-13120136877 | zhaowb.cool@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31570084 | Background | 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. | |
| 29127270 | Result |
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| Oral antiplatelet | Drug | Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy. |
|
Scandinavian Stroke Scale (SSS): stroke symptom severity scale with a range of 0-58. Lower score means more severe stroke symptoms.
| 0-30 days of intervention. |
| The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS). | 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). | 0-90 days. |
| Rate of symptomatic intracerebral hemorrhage. | 0-90 days |
| Number of Participants experienced adverse events | 0-90 days. |
| Beijing Luhe Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| The first Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | Luoyang | Henan | China |
|
| Nanyang Central Hospital | Recruiting | Nanyang | Henan | China |
|
| Nanyang Second General Hospital | Recruiting | Nanyang | Henan | China |
|
| First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | China |
|
| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
|
| The Third People's Hospital of Hubei Province | Active, not recruiting | Wuhan | Hubei | China |
| Hunan Provincial People's Hospital | Not yet recruiting | Changsha | Hunan | China |
|
| Sinapharm North Hospital | Recruiting | Baotou | Inner Mongolia | China |
|
| Ordos Central Hospital | Recruiting | Ordos | Inner Mongolia | China |
|
| Tongliao City Hosptial | Recruiting | Tongliao | Inner Mongolia | China |
|
| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
|
| Jiangxi Provincial People's Hospital | Active, not recruiting | Nanchang | Jiangxi | China |
| Shandong Provincial Hospital | Not yet recruiting | Jinan | Shandong | China |
|
| Shandong Provincial Qianfoshan Hospital | Active, not recruiting | Jinan | Shandong | China |
| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
|
| Beichen Hospital of Traditional Chinese Medicine | Recruiting | Tianjin | Tianjin Municipality | China |
|
| TEDA Hospital | Active, not recruiting | Tianjin | Tianjin Municipality | China |
| 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. |
| 40012523 | Derived | Qiao Y, Zhao M, Wang J, Li S, Yang T, Wang P, Ji X, Ma Q, Zhao W. Stroke etiology was associated with tirofiban efficacy in acute ischemic stroke without endovascular treatment: A pre-specified subgroup analysis of the TREND trial. Int J Stroke. 2025 Oct;20(8):977-986. doi: 10.1177/17474930251326423. Epub 2025 Feb 27. |
| 39950764 | Derived | 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. |
| 39036300 | Derived | 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. |
| 38648030 | Derived | 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. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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