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Rationale and design of a double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of nimodipine in preventing cognitive impairment in ischemic cerebrovascular events (NICE)

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机构: [1]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China
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Background: Stroke is the second most common cause of mortality and the leading cause of neurological disability, cognitive impairment and dementia worldwide. Nimodipine is a dihydropyridinic calcium antagonist with a role in neuroprotection, making it a promising therapy for vascular cognitive impairment and dementia. Methods/design: The NICE study is a multicenter, randomized, double-blind, placebo-controlled study being carried out in 23 centers in China. The study population includes patients aged 30-80 who have suffered an ischemic stroke (<= 7 days). Participants are randomly allocated to nimodipine (90 mg/d) or placebo (90 mg/d). The primary efficacy is to evaluate the level of mild cognitive impairment following treatment of an ischemic stroke with nimodipine or placebo for 6 months. Safety is being assessed by observing side effects of nimodipine. Assuming a relative risk reduction of 22%, at least 656 patients are required in this study to obtain statistical power of 90%. The first patient was recruited in November 2010. Discussion: Previous studies suggested that nimodipine could improve cognitive function in vascular dementia and Alzheimer's disease dementia. It is unclear that at which time-point intervention with nimodipine should occur. Therefore, the NICE study is designed to evaluate the benefits and safety of nimodipine, which was adminstered within seven days, in preventing/treating mild cognitive impairment following ischemic stroke.

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出版当年[2011]版:
大类 | 3 区 医学
小类 | 3 区 临床神经病学
最新[2025]版:
大类 | 3 区 医学
小类 | 4 区 临床神经病学
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出版当年[2010]版:
Q2 CLINICAL NEUROLOGY
最新[2024]版:
Q3 CLINICAL NEUROLOGY

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第一作者机构: [1]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China
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通讯机构: [1]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China
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