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CompletedNCT01405248BPRIASUpdated Oct 26, 2015

Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

A Phase 3 interventional study of Butylphthalide and Placebo in Restenosis, sponsored by Jinling Hospital, China. Completed at 1 site in China. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-10-26.

Sponsored by Jinling Hospital, China · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Restenosis

Keywords

  • Butylphthalide
03

In context

Lead sponsor

Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Butylphthalide

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

    Drug: Butylphthalide

  • Placebo comparator
    control

    Placebo

    Drug: Placebo

Interventions

  • DrugButylphthalide

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

    Also known as: NBP

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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%.

    Time frame: one year

Secondary outcomes

  1. 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.

    Time frame: at one year

07

Study locations

1 site
  • Department of Neurology ;Jinling Hospital
    Nanjing,, Jiangsu 210002, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01405248
Lead sponsor
Jinling Hospital, China
Collaborators
CSPC-NBP Pharmaceutical Co., Ltd.
Responsible party
Xinfeng Liu (Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting, Jinling Hospital, China) — Principal investigator
First posted
Jul 29, 2011
Start date
Jul 2011
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Oct 26, 2015

Study contacts

Xinfeng Liu, MD
study chair · Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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