Clinical trial NCT04491695: Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke
Official title: Safety and Efficacy of Tirofiban in Preventing Neurological Deterioration of Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acute Stroke
Keywords: Acute ischemic stroke
Neurological deterioration
Stroke progression
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Acute ischemic stroke with 24 hours of symptom onset.
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:

1. Treated with intravenous or endovascular thrombectomy for the indexed acute ischemic stroke.
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.

Primary outcomes:
measure: Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.
timeFrame: Within 72 hours of intervention.
Secondary outcomes:
measure: Change of the NIHSS
timeFrame: 0-30 days of intervention.
measure: Change of the Scandinavian Stroke Scale
timeFrame: 0-30 days of intervention.
measure: The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).
timeFrame: 0-90 days.
measure: Rate of symptomatic intracerebral hemorrhage.
timeFrame: 0-90 days
measure: Number of Participants experienced adverse events
timeFrame: 0-90 days.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
city: Luoyang
country: China
facility: The first Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Nanyang
country: China
facility: Nanyang Second General Hospital
state: Henan
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: The Third People's Hospital of Hubei Province
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Baotou
country: China
facility: Sinapharm North Hospital
state: Inner Mongolia Autonomous Region
city: Ordos
country: China
facility: Ordos Central Hospital
state: Inner Mongolia Autonomous Region
city: Tongliao
country: China
facility: Tongliao City Hosptial
state: Inner Mongolia Autonomous Region
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Beichen Hospital of Traditional Chinese Medicine
state: Tianjin
city: Tianjin
country: China
facility: TEDA Hospital
state: Tianjin
Study officials:
References:
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.
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.