Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting (BPRIAS)

Jinling Hospital, China

Status and phase: Completed; Phase 3

Conditions: Restenosis

Treatments: Drug: Butylphthalide; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01405248

BPRIAS

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Butylphthalide

Experimental group

Description:

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

Treatment:

Drug: Butylphthalide

control

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo