Effectiveness of Butylphthalide on Dynamic Cerebral Autoregulation in Patients With Acute Ischemic Stroke.
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, triple-blind, placebo-controlled, multicenter clinical trial. Eligible
      patients will be randomized into either the butylphthalide (NBP) or placebo group in a 2:1
      ratio.The main purpose of this study is to determine whether butylphthalide can improve
      dynamic Cerebral Autoregulation (dCA) in large-artery atherosclerosis acute ischemic stroke.
    

Detailed description: 
      Cerebral stroke, the first cause of death in China, seriously affects the health and living
      of people. Its high incidence, disability, mortality and recurrence rate give a heavy burden
      on the family, society and country. According to TOAST classification, large-artery
      atherosclerosis ischemic stroke is one of the most common subtypes, and majority experts
      demonstrate its dynamic Cerebral Autoregulation (dCA) is impaired in affected hemisphere.

      Thrombolytic therapy with intravenous tissue plasminogen activator (tPA), which remains the
      only therapeutic drug for acute ischemic stroke approved by the US Food and Drug
      Administration, is limited by the narrow time window of thrombolysis, bleeding complications,
      or high costs. Other treatment strategies mainly utilize therapeutic agents to prevent or
      reduce cell damage from ischemia. Butylphthalide (NBP) is a multiple target drug for the
      treatment of acute mild to moderate ischemic cerebral stroke.

      Cerebral autoregulation (CA) is the main mechanism that maintains relatively constant
      cerebral blood flow, which is critical for the normal functioning of physiological functions,
      as well as the occurrence, development and prognosis of the cerebral stroke.whether NBP can
      improve the dCA in large-artery atherosclerosis acute ischemic stroke has not been
      illustrated.

      Thus, in this study, investigators plan to enroll 99 eligible patients, which will be
      randomized into either the NBP or placebo group in a 2:1 ratio within 90 days follow-up to
      explore whether NBP can improve the dCA in large-artery atherosclerosis acute ischemic
      stroke. DCA measurement will be performed at 0, 14 and 90 days after entering the trial,
      nurses will collect intravenous blood 6ml 3 times (each time before dCA measurement, the
      blood samples will be stored for laboratory test). Clinical information and follow-up
      information will be collected and recorded in case report form (CRF) once signing of informed
      consent.
    

Intervention name(s): butylphthalide(NBP); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2014), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.In addition, 25mg butylphthalide(NBP) injection, and 100ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, infusion for 14 days, then, butylphthalide(NBP) capsule for 76 days.; Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2014), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.In addition, 100ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, infusion for 14 days, then, starch capsule for 76 days.
Intervention MeSH terms: 3-n-butylphthalide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: butylphthalide(NBP); large-artery atherosclerosis acute ischemic stroke; dynamic Cerebral Autoregulation(dCA)