Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

Restenosis Clinical Trial

— BPRIAS  

Official title:

Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405248
• Other study ID #: BPRIAS
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2011
• Last updated: October 22, 2015
• Start date: July 2011
• Est. completion date: January 2014

Study information

• Verified date: October 2015
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Restenosis

Intervention

Drug:
• Butylphthalide
20 mg/time per os three times a day. 180days
• Placebo
20 mg/time per os three times a day. 180days

Locations

Country	Name	City	State
China	Department of Neurology ;Jinling Hospital	Nanjing,	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jinling Hospital, China	CSPC-NBP Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occlusion and restenosis	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%.	one year	Yes
Secondary	NIHSS, mRS	NIHSS and mRS are widely used stroke deficit assessment tools. Most clinical stroke-related trials require a baseline and outcome severity assessment. The baseline of mRS is rank 0, NIHSS 0; the severity of mRS is 6, NIHSS 42. AS many patients have one or more strokes before they perform stening, this study selected NIHSS and mRS as the supplementary materials to estimate the stroke deficit of patients and to reflect the therapeutic effect and safety of stening and butylphthalide therapy.	at one year	Yes