The Impact of NBP on the Collateral Circulation in ICA/M1 Occlusion

NCT02594995 | Completed Phase 4 DMC

• 1 other identifier: SAHZJUNeuro
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is the first leading cause of death in China, and is responsible for almost 22.4% of deaths. In approximately 80% of cases stroke is ischaemic, i.e. caused by disruption of blood flow to part of the brain from an acute arterial occlusion. Survival of penumbral tissue distal to an arterial occlusion depends on collateral circulation via the Circle of Willis and leptomeningeal anastomises. Collateral flow is dynamic and failure is associated with infarct growth. The presence of adequate collaterals has been shown to be associated with age, history of statin use, and non-hypertension. Dl-3-n-butylphthalide (NBP), isolated from the seeds of celery, and found to exert protective effects against ischemic brain and increase leptomeningeal blood flow. This study investigate whether NBP injection prescribed during acute stroke will have a significant effect to improve collateral circulation in patients of anterior circulation occlusion.

Conditions

Cerebrovascular Occlusion; Collateral Blood Circulation; Anterior Cerebral Circulation Infarction

Outcome Measures

Primary Outcomes (1)

• the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2

  3 months

Secondary Outcomes (5)

• rLMC scale of Collateral circulation

  2 weeks, 3 months

• NIHSS score

  1 week, 2 weeks, 3 months

• Hemorrhageic complications including intracranial, digestive tract

  2 weeks, 3 months

• New stroke or transient ischemic attack(TIA)

  3 months

• complete blood count

  3 months

Study Arms (4)

NBP in thrombolysis group

EXPERIMENTAL

NBP 25mg bid for 2 weeks administered after 24 hours after receiving recombinant plasminogenactivator(rt-PA) thrombolysis

Drug: NBP

NBP group

EXPERIMENTAL

NBP 25mg bid for 2 weeks administered for the patients who do not receive rt-PA

Drug: NBP

Control group

NO INTERVENTION

Control group not receiving rt-PA thrombolysis, receiving basic therapy for acute stroke, e.g. aspirin/clopidogrel and lipid-lowering therapy

Control in thrombolysis group

NO INTERVENTION

Control group receiving rt-PA thrombolysis

Interventions

NBP DRUG

NBP group; NBP in thrombolysis group

Eligibility Criteria

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

You may qualify if:

• Men or women ≥ 18 years old;
• Acute occlusion of M1 or intracranial internal carotid artery within 72 hours;
• For patients who receive recombinant tissue-type plasminogenactivator therapy, the arterial occlusive lesion scale of 24-72 hours post-thrombolysis imaging should be 0 or 1;
• Ischemic stroke with National Institutes of Health Stroke Scale ≥ 4;
• Baseline mRS before this stroke onset less than 2;
• Able and willing to comply with study requirements;
• Signed informed consent by patients self or legally authorized representatives.

You may not qualify if:

• Cerebral hemorrhage;
• Posterior circulation infarction;
• Severe tendency of hemorrhage, such as thrombocytopenia, leukemia, allergic purpura;
• Currently using urinary kallidinogenase or alprostadil;
• Be allergic to NBP or celery;
• Impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl);
• Patients with evidence of severe congestive heart failure or history of end-stage cardiovascular disease (e.g. congestive heart failure New York Heart Association Class III or IV);
• Metastatic neoplasm or multiple organ failure;
• Pregnancy or breastfeeding;
• History of mental instability or dementia.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Cerebrovascular Disorders; Brain Infarction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Stroke; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Min Lou, Ph.D, M.D.

  second affiliated hospital of Zhejiang University, school of medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: November 3, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 30, 2019
• Last Updated: March 31, 2020

Record last verified: 2016-04

Locations

CN (1)