Cinepazide Maleate Injection in the Treatment of Acute Ischemic Stroke A Blind, Multicenter, Placebo-controlled Clinical Confirmatory Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- score of modified Rankin Scale(MRS)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel controlled, post marketing confirmatory clinical trial in Chinese patients with acute ischemic stroke. Objective to evaluate the efficacy and safety of cinepazide maleate injection compared with placebo in the treatment of patients with acute ischemic stroke.
详细描述
The target population of this study is patients with acute ischemic stroke within 48 hours. All potential participants must provide informed consent, and those who provide informed consent will enter the screening (- 48 ~ 0h), and the screening qualification will be evaluated according to the inclusion criteria. The eligible subjects will enter the treatment period (day 1-14) and will be randomly assigned to the experimental group (cinepazide maleate injection group) or the control group (placebo group).
During the treatment period, all subjects will receive cinepazide maleate injection or placebo by intravenous drip at the rate of 100ml / h, once a day for 14 consecutive days. During the treatment, all subjects need to receive basic treatment: citicoline sodium injection 0.5g, dissolved in 5% glucose injection or normal saline 250ml, intravenous drip slowly, once a day, continuous administration for 10 days. According to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke (2014), the patients were given antihypertensive, hypoglycemic, lipid-lowering, anticoagulant or mannitol. All subjects were not allowed to receive interventional therapy, thrombolysis (such as rtPA and urokinase), defibrillator, any platelet inhibitor except aspirin and clopidogrel, other cerebrovascular dilators (such as cinnarizine, flunarizine, nicardipine and nimodipine), other neuroprotective agents (except citicoline) during the whole trial period After the end of the treatment period (the 14th day), the subjects will enter the follow-up period (the 15th-90th day).
During the follow-up period, subjects need to be followed up twice (30th day) ± 2 days, 90th day ± 3 days).
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
- Double (Participant, Investigator)
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
- •18-80 years old (contains 18 and 80 years), with no limit for both sexes;
- •Acute internal carotid artery was diagnosed according to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke (2014) Cerebral infarction of the arterial system (anterior circulation), well after first onset or last onset (MRS score 0-1) patients;
- •Onset ≤ 48 hours (onset to randomization within 48 hours);
- •5 points ≤ NIHSS ≤ 25 at presentation;
- •Informed consent was signed by the patients or their legal surrogates.
排除标准
- •Patients with recurrent cerebral infarction with pre Mrs score ≥ 2 at this time;
- •Cranial CT suggestive of intracranial haemorrhagic disease (e.g Intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.);
- •Cerebral infarction with impaired consciousness (NIHSS score of 1A items ≥ 1), transient ischemic attack Zuo, cerebral arteritis, brain tumor, brain trauma, intracranial infection, cerebral parasite disease patients;
- •Patients who have undergone or require interventional, thrombolytic, and defibrillation therapy after this episode;
- •History or evidence of any one of the following diseases during the screening period:
- •poorly controlled hypertension with systolic blood pressure ≥ 200mmhg or diastolic blood pressure ≥ 110mmhg during screening period;
研究组 & 干预措施
Test group (cinnarizide maleate injection group)
干预措施: Cinepazide Maleate (Drug)
control group (placebo group)
干预措施: Placebo (Other)
结局指标
主要结局
score of modified Rankin Scale(MRS)
时间窗: at day 90
proportion of subjects with a modified Rankin Scale (MRS) ≤ 2
次要结局
- ability of daily life(at day 90)