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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT02594995

First received: October 22, 2015

Last updated: April 17, 2016

Last verified: April 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

October 22, 2015

Last Updated Date

April 17, 2016

Start Date ^ICMJE

July 2015

Estimated Primary Completion Date

September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2 [ Time Frame: 3 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02594995 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

rLMC scale of Collateral circulation [ Time Frame: 2 weeks, 3 months ]
We use regional leptomeningeal score(rLMC) score to measure collateral circulation.rLMC score is based on scoring pial and lenticulostriate arteries in 6 ASPECTS regions(M1-6) plus anterior cerebral artery region and basal ganglia. Pial arteries in the Sylvian sulcus are scored 0,2, or 4.
NIHSS score [ Time Frame: 1 week, 2 weeks, 3 months ]
Hemorrhageic complications including intracranial, digestive tract [ Time Frame: 2 weeks, 3 months ]
New stroke or transient ischemic attack(TIA) [ Time Frame: 3 months ]
complete blood count [ Time Frame: 3 months ]

Original Secondary Outcome Measures ^ICMJE

rLMC scale of Collateral circulation [ Time Frame: 2 weeks, 3 months ]
We use regional leptomeningeal score(rLMC) score to measure collateral circulation.rLMC score is based on scoring pial and lenticulostriate arteries in 6 ASPECTS regions(M1-6) plus anterior cerebral artery region and basal ganglia. Pial arteries in the Sylvian sulcus are scored 0,2, or 4.
NIHSS score [ Time Frame: 1 week, 2 weeks, 3 months ]
Hemorrhageic complications including intracranial, digestive tract [ Time Frame: 2 weeks, 3 months ]
New stroke or transient ischemic attack(TIA) [ Time Frame: 3 months ]
liver function/renal function/complete blood count/coagulation function [ Time Frame: 3 months ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Impact of NBP on the Collateral Circulation in Acute Acute Internal Carotid Artery(ICA)/Middle Cerebral Artery(M1) Occlusion

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Cerebrovascular Occlusion
Collateral Blood Circulation
Anterior Cerebral Circulation Infarction

Intervention ^ICMJE

Drug: NBP

Study Arms

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

Intervention: Drug: NBP
Experimental: NBP group
NBP 25mg bid for 2 weeks administered for the patients who do not receive rt-PA

Intervention: Drug: NBP
No Intervention: Control group
Control group not receiving rt-PA thrombolysis, receiving basic therapy for acute stroke, e.g. aspirin/clopidogrel and lipid-lowering therapy
No Intervention: Control in thrombolysis group
Control group receiving rt-PA thrombolysis

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

568

Estimated Completion Date

September 2016

Estimated Primary Completion Date

September 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02594995

Other Study ID Numbers ^ICMJE

SAHZJUNeuro

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Sponsor ^ICMJE

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Min Lou, Ph.D, M.D.

second affiliated hospital of Zhejiang University, school of medicine

PRS Account

Second Affiliated Hospital, School of Medicine, Zhejiang University

Verification Date

April 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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