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Completed

NCT Number: NCT02594995

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NBP

Drug

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. 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.

  2. NIHSS score

    Time frame: 1 week, 2 weeks, 3 months

  3. Hemorrhageic complications including intracranial, digestive tract

    Time frame: 2 weeks, 3 months

  4. New stroke or transient ischemic attack(TIA)

    Time frame: 3 months

  5. complete blood count

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: INCIMO

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Nov 3, 2015
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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