Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

NCT01405248 | Completed Phase 3 DMC

• 1 other identifier: BPRIAS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Restenosis

Keywords

Butylphthalide

Outcome Measures

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%.

  one year

Secondary Outcomes (1)

• NIHSS, mRS

  at one year

Study Arms (2)

Butylphthalide

EXPERIMENTAL

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

Drug: Butylphthalide

control

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Butylphthalide DRUG

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

Also known as: NBP

Butylphthalide

Placebo DRUG

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

control

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;
• A successful cerebrovascular carotid stenting noted.

You may not qualify if:

• There is a serious bleeding tendency, nearly three months have intracranial bleeding or cranial out blood;
• Active peptic ulcer;
• Not good control high blood pressure; the wickedness of
• Blood vessel distortion, variation, narrow degree badly, can not be implemented stents operation;
• Serious cardiopulmonary etc medical problems;
• Those allergic to celery;
• Contrast agents allergy;
• Can't complete follow-up.

Sponsors & Collaborators

• Jinling Hospital, China: lead
• CSPC-NBP Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Department of Neurology ;Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Interventions

3-n-butylphthalide

Study Officials

• Xinfeng Liu, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 26, 2015

Record last verified: 2015-10

Locations

CN (1)