A Phase 4 interventional study of NBP in Cerebrovascular Occlusion, Collateral Blood Circulation and Anterior Cerebral Circulation Infarction, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-31.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 4, Interventional, and Basic science
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.
93 studies on the registry are indexed under Brain Infarction; 19 are open to participants now.
This study's enrollment of 311 is above the median of 134 across 67 interventional studies indexed under Brain Infarction.
Browse Brain Infarction studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Compared within Brain Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cerebrovascular Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NBP 25mg bid for 2 weeks administered after 24 hours after receiving recombinant plasminogenactivator(rt-PA) thrombolysis
Drug: NBP
NBP 25mg bid for 2 weeks administered for the patients who do not receive rt-PA
Drug: NBP
Control group not receiving rt-PA thrombolysis, receiving basic therapy for acute stroke, e.g. aspirin/clopidogrel and lipid-lowering therapy
Control group receiving rt-PA thrombolysis
the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2
Time frame: 3 months
rLMC scale of Collateral circulation
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.
Time frame: 2 weeks, 3 months
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
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Butylphthalide
Second Affiliated Hospital, School of Medicine, Zhejiang University →