LOMCAD 试验研究方案：盐酸洛美利嗪预防 CADASIL 患者脑缺血事件复发的效果。

IF 2 4区医学 Q3 NEUROSCIENCES

Journal of Stroke & Cerebrovascular Diseases Pub Date : 2024-10-24 DOI:10.1016/j.jstrokecerebrovasdis.2024.108042

Toshiki Mizuno MD, PhD , Tomoyuki Ohara MD, PhD , Ikuko Mizuta MD, PhD , Akari Naito MS , Mitsuko Nakata PhD , Aoi Uno-Kadowaki MS , Yayoi Iwami BS , Akiko Watanabe-Hosomi MD, PhD , Hiraku Matsuura MD , Daiki Fukunaga MD , Toshiko Ito-Ihara MD, PhD , Satoshi Teramukai PhD

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引用次数: 0

摘要

研究目的大脑常染色体显性动脉病伴有皮层下梗死和白质脑病（CADASIL）是最常见的单基因脑小血管疾病之一。我们之前的观察性研究表明，1999 年日本批准用于预防偏头痛的钙通道阻滞剂盐酸洛美利嗪也能有效预防 CADASIL 患者的复发性缺血性中风。本研究（LOMCAD 试验）旨在验证盐酸洛美利嗪的疗效：这是一项多中心、前瞻性、单臂试验，使用历史对照进行比较。过去两年内有两次或两次以上脑缺血事件病史的 CADASIL 患者将服用盐酸洛美利嗪（5 毫克片剂，每天两次）24 个月。主要终点是 24 个月期间的无症状脑缺血事件。利用我们的历史数据和基于先验预测分布的贝叶斯样本量计算，确定计划样本量为 20 例受试者：我们计划开展一项临床试验，以验证盐酸洛美利嗪作为预防药物预防 CADASIL 患者复发性脑缺血事件的有效性：LOMCAD试验已在日本临床试验注册中心注册（jRCTs051220072，https://jrct.niph.go.jp/latest-detail/jRCTs051220072）。

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Study protocol for LOMCAD Trial: Effect of lomerizine hydrochloride to prevent recurrence of cerebral ischemic events in CADASIL patients

Objectives

Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) is one of the most common monogenic cerebral small vessel diseases. Our previous observational study suggested that lomerizine hydrochloride, a calcium channel blocker approved in Japan in 1999 for the prevention of migraine headaches, is also effective for preventing recurrent ischemic stroke in CADASIL patients. The aim of this study (LOMCAD trial) is to verify the efficacy of lomerizine hydrochloride.

Materials and Methods

This is a multicenter, prospective, single-arm trial, using a historical control for comparison. CADASIL patients with a history of two or more cerebral ischemic events within the last two years will be administered lomerizine hydrochloride (5-mg tablet twice daily) for 24 months. The primary endpoint is symptomatic cerebral ischemic events during the 24-month period. Using our historical data and Bayesian sample size calculation based on a prior predictive distribution, the planned sample size was determined as 20 subjects.

Conclusion

We have planned a clinical trial to verify the effectiveness of lomerizine hydrochloride as prophylaxis to prevent recurrent cerebral ischemic events in CADASIL patients.

Registration

The LOMCAD trial has been registered in the Japan Registry of Clinical Trials (jRCTs051220072, https://jrct.niph.go.jp/latest-detail/jRCTs051220072).

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来源期刊

Journal of Stroke & Cerebrovascular Diseases Medicine-Surgery

CiteScore

5.00

自引率

4.00%

发文量

583

审稿时长

62 days

期刊介绍： The Journal of Stroke & Cerebrovascular Diseases publishes original papers on basic and clinical science related to the fields of stroke and cerebrovascular diseases. The Journal also features review articles, controversies, methods and technical notes, selected case reports and other original articles of special nature. Its editorial mission is to focus on prevention and repair of cerebrovascular disease. Clinical papers emphasize medical and surgical aspects of stroke, clinical trials and design, epidemiology, stroke care delivery systems and outcomes, imaging sciences and rehabilitation of stroke. The Journal will be of special interest to specialists involved in caring for patients with cerebrovascular disease, including neurologists, neurosurgeons and cardiologists.