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临床试验/NCT01405248
NCT01405248已完成3 期

Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
occlusion and restenosis

研究概览

简要总结

The purpose of this study is to determine whether butylphthalide are effective for Preventing Restenosis after Intracranial and Extracranial Artery Stenting

详细描述

Ischemic stroke is a significant cause of death, most of the patients is caused by atherosclerosis,current treatments include internal medicine medications, interventional treatment and so on,among them, the interventional therapy can make narrow blood vessels blood recovery fastly,and for its small trauma,Gradually accepted by psychiatrist, But stents are easy to narrow has been plagued by everybody ,At present, prevent restenosis stent is mainly of antiplatelet therapy,But,prevention effect is not obvious often easy to appear harmful response,how to effectively reduce postoperative restenosis, become the majority concern of patients and doctors .Clinical trials showed that, butylbenzene can promote the function of ischemic stroke recovery patients. Animal pharmacodynamics study suggests that this product can block the ischemic stroke of brain damage caused by DuoGe pathological link, with strong against ischemic and brain protection, especially can obviously increase in small brains ischemia ATP and phosphoric acid creatine level, decrease local cerebral ischemia in rats, reduce infarct size, cerebral edema improved energy metabolism and brain ischemia of microcirculation and blood flow in the brain, restrain the nerve cell apoptosis, and has the cerebral thrombosis and anti-platelet aggregation function. Research shows that, butylbenzene phthalocyanine influence through arachidonic acid (AA) metabolism, selective inhibition and their metabolites from DuoZhong mediated pathophysiological events, can remove microvascular spasms. Inhibit platelet aggregation, restrain TXA2 synthesis, scavenging free radicals, thereby through many ways, many link blocking caused by cerebral ischemia the pathophysiology of development process. These mechanisms may make butylbenzene in preventing phthalocyanine intracranial carotid stenting noted restenosis and related ischemia of events play an important role.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • . DSA check to be sure, the VA, BA ICA, MCA, PCA and other major blood vessels, have corresponding stenosis of symptoms more than 50%, not corresponding symptoms stenosis of greater than 70%;
  • . A successful cerebrovascular carotid stenting noted.

排除标准

  • . There is a serious bleeding tendency, nearly three months have intracranial bleeding or cranial out blood;
  • . Active peptic ulcer;
  • . Not good control high blood pressure; the wickedness of
  • . Blood vessel distortion, variation, narrow degree badly, can not be implemented stents operation;
  • . Serious cardiopulmonary etc medical problems;
  • . Those allergic to celery;
  • . Contrast agents allergy;
  • . Can't complete follow-up.

研究组 & 干预措施

Butylphthalide

Experimental

Single center of the placebo control a double-blind randomized control study to evaluate Butylphthalide prevention stents restenosis effect

干预措施: Butylphthalide (Drug)

control

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

occlusion and restenosis

时间窗: one year

Stenosis detected by DSA(digital subtraction angiography), CTA(CT angiography) or MRA(MR angiography) was measured according to NASCET (North American Symptomatic Carotid Endarterectomy Trial) method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET = (1-md/C)×100%.

次要结局

  • NIHSS, mRS(at one year)

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinfeng Liu

Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

Jinling Hospital, China

研究点 (1)

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