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)
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.
基金:
Minister of Science and Technology of the People's Republic of China
第一作者机构:[1]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China
通讯作者:
通讯机构:[1]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China
推荐引用方式(GB/T 7714):
Wang Penglian,Wang Yongjun,Feng Tao,et al.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)[J].BMC NEUROLOGY.2012,12:-.doi:10.1186/1471-2377-12-88.
APA:
Wang, Penglian,Wang, Yongjun,Feng, Tao,Zhao, Xingquan,Zhou, Yong...&Ju, Yi.(2012).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).BMC NEUROLOGY,12,
MLA:
Wang, Penglian,et al."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)".BMC NEUROLOGY 12.(2012):-