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

This study has been completed.
Sponsor:
Collaborator:
CSPC-NBP Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Xinfeng Liu, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01405248
First received: July 28, 2011
Last updated: October 26, 2014
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Restenosis
Drug: Butylphthalide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • occlusion and restenosis [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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%.


Secondary Outcome Measures:
  • NIHSS, mRS [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 100
Study Start Date: July 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Butylphthalide
Single centers of the placebo control a double-blind randomized control study to evaluate drug prevention stents restenosis effect
Drug: Butylphthalide
20 mg/time per os three times a day. 180days
Other Name: NBP
Placebo Comparator: control
Placebo

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, butyl benzene 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, butyl benzene 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 butyl benzene in preventing phthalocyanine intracranial carotid stenting noted restenosis and related ischemia of events play an important role.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405248

Locations
China, Jiangsu
Department of Neurology ;Jinling Hospital
Nanjing,, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China
CSPC-NBP Pharmaceutical Co., Ltd.
Investigators
Study Chair: Xinfeng Liu, MD Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
  More Information

No publications provided

Responsible Party: Xinfeng Liu, Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01405248     History of Changes
Other Study ID Numbers: BPRIAS
Study First Received: July 28, 2011
Last Updated: October 26, 2014
Health Authority: China: Ministry of Health

Keywords provided by Jinling Hospital, China:
Butylphthalide

Additional relevant MeSH terms:
3-n-butylphthalide
Central Nervous System Agents
Hematologic Agents
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014