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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBP in thrombolysis group | Experimental | NBP 25mg bid for 2 weeks administered after 24 hours after receiving recombinant plasminogenactivator(rt-PA) thrombolysis |
|
| NBP group | Experimental | NBP 25mg bid for 2 weeks administered for the patients who do not receive rt-PA |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBP | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Lou, Ph.D, M.D. | second affiliated hospital of Zhejiang University, school of medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hospital of Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D020520 | Brain Infarction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| 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 |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D020521 | Stroke |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |