The Impact of NBP on the Collateral Circulation in Acute Acute Internal Carotid Artery(ICA)/Middle Cerebral Artery(M1) Occlusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2
研究概览
简要总结
Stroke is the first leading cause of death in China, and is responsible for almost 22.4% of deaths. In approximately 80% of cases stroke is ischaemic, i.e. caused by disruption of blood flow to part of the brain from an acute arterial occlusion. Survival of penumbral tissue distal to an arterial occlusion depends on collateral circulation via the Circle of Willis and leptomeningeal anastomises. Collateral flow is dynamic and failure is associated with infarct growth. The presence of adequate collaterals has been shown to be associated with age, history of statin use, and non-hypertension. Dl-3-n-butylphthalide (NBP), isolated from the seeds of celery, and found to exert protective effects against ischemic brain and increase leptomeningeal blood flow. This study investigate whether NBP injection prescribed during acute stroke will have a significant effect to improve collateral circulation in patients of anterior circulation occlusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Men or women ≥ 18 years old;
- •Acute occlusion of M1 or intracranial internal carotid artery within 72 hours;
- •For patients who receive recombinant tissue-type plasminogenactivator therapy, the arterial occlusive lesion scale of 24-72 hours post-thrombolysis imaging should be 0 or 1;
- •Ischemic stroke with National Institutes of Health Stroke Scale ≥ 4;
- •Baseline mRS before this stroke onset less than 2;
- •Able and willing to comply with study requirements;
- •Signed informed consent by patients self or legally authorized representatives.
排除标准
- •Cerebral hemorrhage;
- •Posterior circulation infarction;
- •Severe tendency of hemorrhage, such as thrombocytopenia, leukemia, allergic purpura;
- •Currently using urinary kallidinogenase or alprostadil;
- •Be allergic to NBP or celery;
- •Impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl);
- •Patients with evidence of severe congestive heart failure or history of end-stage cardiovascular disease (e.g. congestive heart failure New York Heart Association Class III or IV);
- •Metastatic neoplasm or multiple organ failure;
- •Pregnancy or breastfeeding;
- •History of mental instability or dementia.
研究组 & 干预措施
NBP in thrombolysis group
NBP 25mg bid for 2 weeks administered after 24 hours after receiving recombinant plasminogenactivator(rt-PA) thrombolysis
干预措施: NBP (Drug)
NBP group
NBP 25mg bid for 2 weeks administered for the patients who do not receive rt-PA
干预措施: NBP (Drug)
结局指标
主要结局
the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2
时间窗: 3 months
次要结局
- complete blood count(3 months)
- Hemorrhageic complications including intracranial, digestive tract(2 weeks, 3 months)
- New stroke or transient ischemic attack(TIA)(3 months)
- NIHSS score(1 week, 2 weeks, 3 months)
- rLMC scale of Collateral circulation(2 weeks, 3 months)