Efficacy and Safety of Tirofiban Therapy in Acute Ischemic Stroke Patients Beyond the Time Window Guided by High-Resolution Magnetic Resonance Imaging
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- Proportion of participants with functional independence outcome [modified Rankin Scale(mRS) score 0-1]
研究概览
简要总结
This study aims to address the existing clinical challenges by introducing high-resolution magnetic resonance vessel wall imaging (HR-MRI), an advanced imaging technology, to achieve precise etiological classification in patients with acute ischemic stroke (AIS) beyond the time window. HR-MRI allows clear visualization of intracranial arterial wall structures and direct identification of key pathological features of the culprit vessel, including atherosclerotic plaques, vascular wall remodeling, and intracranial hemorrhage, thereby enabling reliable differentiation between intracranial atherosclerotic large artery atherosclerosis (ICAS-LAA) stroke and other etiological subtypes such as cardiogenic embolism. Based on the latest clinical demands and advances in imaging technology, this study intends to evaluate the efficacy and safety of tirofiban in patients with ICAS-LAA stroke beyond the time window under the precise guidance of HR-MRI. It is expected to provide high-level evidence-based medical evidence for this specific patient population and further optimize clinical diagnosis and treatment strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Acute ischemic stroke (AIS) in the anterior intracranial circulation (internal carotid artery system) confirmed by clinical symptoms and imaging examinations;
- •Time from symptom onset or last known normal state to randomization: > 24 hours and ≤ 7 days;
- •Stroke subtype confirmed as intracranial large artery atherosclerosis (ICAS) by high-resolution vessel wall imaging (HR-VWI) according to the TOAST classification, with cardiogenic embolism and other etiologies excluded;
- •Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-20 at the time of randomization;
- •Signed informed consent form obtained from the patient or their legal representative.
排除标准
- •Planned to receive reperfusion therapy (endovascular therapy or intravenous thrombolysis)；
- •Intracranial hemorrhage confirmed by computed tomography (CT)；
- •Definite or suspected cardiogenic embolism；
- •History of atrial fibrillation or current electrocardiogram indicating atrial fibrillation；
- •Acute ischemic stroke caused by other etiologies, such as Moyamoya disease, arterial dissection, arteritis, etc；
- •Imaging examinations indicating that the area of the current cerebral infarction exceeds 1/2 of the area of a single cerebral lobe;
- •Known contraindications to antiplatelet therapy, including hematochezia, gastrointestinal bleeding, or any other hemorrhagic disorders;
- •History of hypersensitivity to aspirin;
- •Definite indication for anticoagulant therapy expected during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state, etc.);
- •Complicated with malignant tumors, chronic hemodialysis, severe renal insufficiency (glomerular filtration rate [GFR] < 30 ml/min or serum creatinine [Cr] > 220 μmol/L (2.5 mg/dl)), or severe hepatic insufficiency (serum alanine aminotransferase [ALT] > 2 times the upper limit of normal [ULN], or serum aspartate aminotransferase [AST] > 2 times the ULN);
- •Severe heart failure (New York Heart Association [NYHA] Functional Classification Class III or IV);
- •Complicated with severe non-cardiovascular comorbidities, with an estimated survival time < 6 months;
- •Concurrent new cerebral infarction in both anterior and posterior circulations;
- •Inability to complete the follow-up procedures;
- •Presence of other known neurological disorders that may complicate the follow-up;
- •Concurrent participation in other therapeutic clinical trials with incomplete treatment and follow-up;
- •Other conditions that the investigators consider inappropriate for enrollment in this study.
研究组 & 干预措施
Standard Medication Therapy Group
Patients were randomized to the control group, with dual antiplatelet therapy (DAPT) initiated as early as possible at a dose of aspirin 100 mg/day plus clopidogrel 75 mg/day for a total of 21 days, followed by long-term maintenance with aspirin 100 mg/day alone.
干预措施: dual antiplatelet therapy (Drug)
Tirofiban Combined with Standard Medication Therapy Group
Patients were randomized to the Tirofiban Combined with Dual Antiplatelet Therapy Group. Intravenous tirofiban was administered within 30 minutes of randomization, with an initial bolus infusion at a rate of 0.4 μg/(kg·min) for 30 minutes, followed by a continuous infusion at 0.1 μg/(kg·min) for 47.5 hours. During this period, dual antiplatelet therapy (DAPT) was initiated at a dose of aspirin 100 mg/day plus clopidogrel 75 mg/day, with an overlapping duration of 4-6 hours. After the completion of tirofiban infusion, dual antiplatelet therapy (aspirin 100 mg/day plus clopidogrel 75 mg/day) was continued for a total of 21 days, followed by long-term maintenance with aspirin 100 mg/day alone.
干预措施: dual antiplatelet therapy (Drug)
Tirofiban Combined with Standard Medication Therapy Group
Patients were randomized to the Tirofiban Combined with Dual Antiplatelet Therapy Group. Intravenous tirofiban was administered within 30 minutes of randomization, with an initial bolus infusion at a rate of 0.4 μg/(kg·min) for 30 minutes, followed by a continuous infusion at 0.1 μg/(kg·min) for 47.5 hours. During this period, dual antiplatelet therapy (DAPT) was initiated at a dose of aspirin 100 mg/day plus clopidogrel 75 mg/day, with an overlapping duration of 4-6 hours. After the completion of tirofiban infusion, dual antiplatelet therapy (aspirin 100 mg/day plus clopidogrel 75 mg/day) was continued for a total of 21 days, followed by long-term maintenance with aspirin 100 mg/day alone.
干预措施: Tirofiban (Drug)
结局指标
主要结局
Proportion of participants with functional independence outcome [modified Rankin Scale(mRS) score 0-1]
时间窗: 90 ± 7 days after randomization
the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death); a lower score indicates a better prognosis.
次要结局
- Proportion of participants with good prognosis (mRS score 0-2)(90 ± 7 days after randomization)
- Proportion of participants with mRS score 0-3(90 ± 7 days after randomization)
- Distribution of mRS scores(90 ± 7 days after randomization)
- EuroQol Five-Dimension Questionnaire (EQ-5D) score(90 ± 7 days after randomization)
- Barthel Index (BI) score(90 ± 7 days after randomization)
- Proportion of participants with neurological improvement within 24 hours of randomization [≥2-point reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline](24 ± 6 hours)
- National Institutes of Health Stroke Scale (NIHSS) scores(Time Frame: 24h; before discharge; day7)
- Proportion of participants with symptomatic intracranial hemorrhage (sICH) within 24 hours of randomization(24 ± 6 hours)
- Early neurological deterioration(END)(24 ± 6 hours)
- Incidence of serious adverse events (SAEs)(24 ± 6 hours;)
- Incidence of any adverse events(24 ± 6 hours;)
- Recurrent stroke(90 ± 7 days after randomization)
- all-cause mortality;(90 ± 7 days after randomization)
- stroke-related mortality(90 ± 7 days after randomization)
- Proportion of participants with any intracranial hemorrhage(24 ± 6 hours)
研究者
Weili Li
Professor
Weifang Medical University