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

Purpose

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.

Condition	Intervention	Phase
Cerebrovascular Occlusion Collateral Blood Circulation Anterior Cerebral Circulation Infarction	Drug: NBP	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	The Impact of NBP on the Collateral Circulation in Acute Acute Internal Carotid Artery(ICA)/Middle Cerebral Artery(M1) Occlusion

Further study details as provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	568
Study Start Date:	July 2015
Estimated Study Completion Date:	September 2016
Estimated Primary Completion Date:	September 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NBP in thrombolysis group NBP 25mg bid for 2 weeks administered after 24 hours after receiving recombinant plasminogenactivator(rt-PA) thrombolysis	Drug: NBP
Experimental: NBP group NBP 25mg bid for 2 weeks administered for the patients who do not receive rt-PA	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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT02594995

Locations


China, Zhejiang
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators


Study Chair:	Min Lou, Ph.D, M.D.	second affiliated hospital of Zhejiang University, school of medicine

More Information


Responsible Party:	Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:	NCT02594995 History of Changes
Other Study ID Numbers:	SAHZJUNeuro
Study First Received:	October 22, 2015
Last Updated:	April 17, 2016

Additional relevant MeSH terms:


Infarction Cerebrovascular Disorders Brain Infarction Ischemia Pathologic Processes Necrosis Brain Diseases	Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Ischemia Stroke

ClinicalTrials.gov processed this record on July 14, 2017

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