Safety and Efficacy of Tirofiban in Preventing Neurological Deterioration of Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 420
- 试验地点
- 19
- 主要终点
- Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.
研究概览
简要总结
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.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke with 24 hours of symptom onset.
- •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).
- •Age 18-80 years old.
- •Informed consent obtained from patient or acceptable patient's surrogate.
排除标准
- •Treated with intravenous or endovascular thrombectomy for the indexed acute ischemic stroke.
- •Acute ischemic stroke caused by determined or suspected cardioembolism.
- •Acute ischemic stroke caused by other determined caused, including moyamoya disease, artery dissection, arteritis, and etc.
- •Pre-stroke mRS ≥2 or the paralyzed limbs are dyskinesia before stroke.
- •Known hematochezia, gastrointestinal bleeding and any other bleeding.
- •Allergy to tirofiban or its solvents.
- •Patients suffered from severe diseases, including malignant tumor, liver cirrhosis, kidney failure, congestive heart failure, and etc.
- •Gastrointestinal or genitourinary tract bleeding within 1 years.
- •Determined coagulation disorders, platelet dysfunction, or platelet count <100*109/L.
- •Major surgical operation or severe trauma within 1 month.
- •Hemorrhagic retinopathy.
- •Chronic hemodialysis.
- •Uncontrolled hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg.
- •Acute pericarditis.
- •Other conditions that determined by the investigators.
研究组 & 干预措施
Oral antiplatelet therapy
Patients will receive oral antiplatelet therapy alone.
干预措施: Oral antiplatelet (Drug)
Tirofiban+Oral antiplatelet therapy
Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.
干预措施: Tirofiban Hydrochloride (Drug)
Tirofiban+Oral antiplatelet therapy
Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.
干预措施: Oral antiplatelet (Drug)
结局指标
主要结局
Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.
时间窗: Within 72 hours of intervention.
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
次要结局
- Change of the NIHSS(0-30 days of intervention.)
- Change of the Scandinavian Stroke Scale(0-30 days of intervention.)
- Rate of symptomatic intracerebral hemorrhage.(0-90 days)
- Number of Participants experienced adverse events(0-90 days.)
- The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).(0-90 days.)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University