Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

NCT ID: NCT01405248

Last Updated: 2015-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-01-31

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.

Conditions

Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Butylphthalide

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

Group Type: EXPERIMENTAL

Butylphthalide

Intervention Type: DRUG

20 mg/time per os three times a day. 180days

control

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

20 mg/time per os three times a day. 180days

Interventions

Butylphthalide

20 mg/time per os three times a day. 180days

Intervention Type: DRUG

Placebo

20 mg/time per os three times a day. 180days

Intervention Type: DRUG

Other Intervention Names

NBP

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC-NBP Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Xinfeng Liu

Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinfeng Liu, MD

Role: STUDY_CHAIR

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Locations

Department of Neurology ;Jinling Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

BPRIAS

Identifier Type: -

Identifier Source: org_study_id