A Random, Double-blind, Placebo- Controlled and Dose-finding, Multi-center, Phase II Clinical Trial of Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- modified Rankin scale
研究概览
简要总结
Using placebo as control, The purpose of this study is to evaluate the efficacy and safety of methanesulfonic acid cinepazide injection to relieve disabled degree of acute cerebral infarction patients, and explore the best safe and effective dose as well as dose method.
详细描述
The study will enroll 288 acute cerebral infarction patients. Patients will be assigned randomly to receive either Methanesulfonic acid cinepazide injection or placebo treatment. All patient in the study will receive standard of care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Follow-up evaluations, including National Institute of Health stroke scale(NIHSS), Barthel index score and modified Rankin scale assessments, will be done periodically until 90 days after onset. The degree of disabled improved will be a primary measure of drug effectiveness.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 75 years old，male/ female；
- •The clinical diagnosis of first onset patients with anterior circulation infarction or who have suffered from stroke in history and complete recover from neurologic impairment (mRS score <2 before this disease）
- •Patients is proved by head skull CT and cerebral hemorrhage was excluded；
- •course of disease≤72h，the NIHSS score is ≥7 and ≤22；
- •Patients who voluntarily sign written informed consent. -
排除标准
- •Patients who suffer from cerebral infarction accompanied by disorder of consciousness, posterior circulation infarction, lacunar infarction and transient ischemic attack.
- •Patients who suffer from brain arteritis, brain tumor, brain injury, intracranial infection, brain parasitic disease, and so on . Patients who suffer from cardiac diseases such as rheumatic heart disease, coronary heart disease with atrial fibrillation .
- •Patients who suffer from severe complications, and expected survival period is within three months.
- •Patients require thrombolysis, anticoagulation, anti- fibrosis treatment .
- •Patients who suffer from serious brain artery stenosis that should go through interventional therapy .
- •Patients whose white blood cells or neutrophils is below the lower limit of the normal reference value .
- •Patients who have bleeding tendency or suffered from serious bleeding in 3 months.
- •Patients who have severe cardiac, liver and kidney disease, or whose kidney and liver function tests was abnormal（ALT,AST≥1.5 times of upper normal limit，Cr>upper normal limit）.
- •Patients who have complications of malignant tumor, serious or progressive disease in blood, digestion or other system.
- •Patients who have complications of mental illness un can not or do not want willing to cooperate .
- •Doubt or does have alcohol, drug abuse history
- •Allergic constitution or allergic to the test drug ingredients .
- •Pregnancy and lactation women or those who has a recent fertility plan
- •Patients who have participated in other clinical experiments three months before this test.
- •The patients who is unsuitable to participate in the clinical test in the view of researchers
研究组 & 干预措施
Cinepazide, Stroke, Injection
Test drug：Methanesulfonic acid cinepazide injection（5ml/125mg）
干预措施: cinepazide (Drug)
palcebo,Stroke,Injection
Placebo：simulation agent of Methanesulfonic acid cinepazide injection（5ml sterile water for injection）
干预措施: placebo (Drug)
结局指标
主要结局
modified Rankin scale
时间窗: 3 month
次要结局
- Barthel index(3 month)