Clinical trial NCT01405248: Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting
Official title: Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restenosis
Keywords: Butylphthalide
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: CSPC-NBP Pharmaceutical Co., Ltd.
First posted: 2011-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. . 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%;
2. . A successful cerebrovascular carotid stenting noted.

Exclusion Criteria:

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

Primary outcomes:
measure: occlusion and restenosis
timeFrame: one year
Secondary outcomes:
measure: NIHSS, mRS
timeFrame: at one year
Other outcomes:
Locations:
city: Nanjing,
country: China
facility: Department of Neurology ;Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
name: Xinfeng Liu, MD
role: STUDY_CHAIR
References: