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)

Abstract

BackgroundStroke 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/designThe 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.DiscussionPrevious 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.

Orgasmic Headache Treated with Nimodipine

“…Nimodipine is a dihydropyridinic calcium antagonist that quickly and easily crosses the blood‐brain barrier and reaches a high concentration in cerebrospinal fluid. It improves cerebral perfusion and reduces neurological deficits . However, patients with serious arrhythmia, myocardial infarction within 6 months, hypotension (BP < 90/60 mm Hg), heart failure, serious kidney incompetence (creatinine > 1.5 times of upper limit of normal value) are contraindicated to nimodipine .…”

Treatment of Vascular Cognitive Impairment

“…Data on longer-term outcomes that are clinically more meaningful are lacking. A large trial assessing the benefit of nimodipine in preventing cognitive decline following acute ischemic stroke is ongoing [56]. Nicardipine has been shown to slow the progression of cognitive decline in several trials [57].…”

Pathogenesis of chronic disorders of cerebral circulation

“…С целью восстановления кровотока через суженные артерии и замедления темпов прогрессирования ХРМК было предложено использовать блокаторы медленных кальциевых каналов, в частности дигидропиридиновые производные, способные модулировать просвет церебральных капилляров и мелких артерий, сохранивших свою нормальную структуру и способность воспринимать соответствующие стимулы [50]. Результаты ряда клинических исследований продемонстрировали способность препаратов этой группы замедлять прогрессирование сосудистой деменции.…”