西洛他唑和单硝酸异山梨酯预防脑血管疾病进展:腔隙干预试验-2 (LACI-2) (ISRCTN14911850)的基线数据和统计分析计划。

IF 4.4 1区 医学 Q1 CLINICAL NEUROLOGY Stroke and Vascular Neurology Pub Date : 2023-04-01 DOI:10.1136/svn-2022-001816
Philip M Bath, Iris Mhlanga, Lisa J Woodhouse, Fergus Doubal, Katherine Oatey, Alan A Montgomery, Joanna M Wardlaw
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引用次数: 1

摘要

背景:脑血管病(SVD)可导致腔隙性卒中(占所有缺血性卒中的25%)、身体虚弱和认知障碍以及血管性和混合性痴呆。没有特定的治疗方法来防止SVD的进展。方法:LACunar干预试验-2是一项由研究者发起的前瞻性随机开放标签盲终点II期可行性研究,评估西洛他唑和单硝酸异山梨酯预防SVD进展的可行性。我们的目的是招募400名临床明显的腔内缺血性卒中患者,并在部分因子设计中随机分配到西洛他唑,单硝酸异山梨酯,两者都使用或不使用,此外还有指导方针的继发性缺血性卒中预防。主要结局是招募的可行性和药物依从性;主要次要结局包括:药物耐受性;随机分组后1年血管事件复发、认知和功能;还有安全(流血、摔倒、死亡)。数据为数字(%)和中位数(IQR)。结果:该试验于2018年2月5日开始,并于2021年5月31日停止招募,随机分配了363例患者,具有以下基线特征:平均年龄64岁(56.0,72.0)岁,女性112岁(30.9%),卒中发作时间为79.0(27.0,244.0)天,高血压267(73.6%),中位血压143.0 (130.0,157.0)/83.0 (75.0,90.0)mm Hg,当前吸烟者67(18.5%),教育程度达到学校毕业考试(A-level)或更高118(32.5%),修改Rankin量表1.0(0.0,1.0),国立卫生研究院卒中量表1.0(1.4),蒙特利尔认知评估26.0(23.0,28.0)和脑成像SVD总分1.0 (0.0,1.0),2.0)。本出版物总结了基线数据并提出了统计分析计划。摘要:该试验目前正在进行后续工作,将于2022年5月31日完成,预计将于2022年10月取得结果。试验注册号:ISRCTN14911850。
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Cilostazol and isosorbide mononitrate for the prevention of progression of cerebral small vessel disease: baseline data and statistical analysis plan for the Lacunar Intervention Trial-2 (LACI-2) (ISRCTN14911850).

Background: Cerebral small vessel disease (SVD) causes lacunar strokes (25% of all ischaemic strokes), physical frailty and cognitive impairment and vascular and mixed dementia. There is no specific treatment to prevent progression of SVD.

Methods: The LACunar Intervention Trial-2 is an investigator-initiated prospective randomised open-label blinded-endpoint phase II feasibility study assessing cilostazol and isosorbide mononitrate for preventing SVD progression. We aimed to recruit 400 patients with clinically evident lacunar ischaemic stroke and randomised to cilostazol, isosorbide mononitrate, both or neither, in addition to guideline secondary ischaemic stroke prevention, in a partial factorial design. The primary outcome is feasibility of recruitment and adherence to medication; key secondary outcomes include: drug tolerability; recurrent vascular events, cognition and function at 1 year after randomisation; and safety (bleeding, falls, death). Data are number (%) and median (IQR).

Results: The trial commenced on 5 February 2018 and ceased recruitment on 31 May 2021 with 363 patients randomised, with the following baseline characteristics: average age 64 (56.0, 72.0) years, female 112 (30.9%), stroke onset to randomisation 79.0 (27.0, 244.0) days, hypertension 267 (73.6%), median blood pressures 143.0 (130.0, 157.0)/83.0 (75.0, 90.0) mm Hg, current smokers 67 (18.5%), educationally achieved end of school examinations (A-level) or higher 118 (32.5%), modified Rankin scale 1.0 (0.0, 1.0), National Institutes Health stroke scale 1.0 (1.4), Montreal Cognitive Assessment 26.0 (23.0, 28.0) and total SVD score on brain imaging 1.0 (0.0, 2.0). This publication summarises the baseline data and presents the statistical analysis plan.

Summary: The trial is currently in follow-up which will complete on 31 May 2022 with results expected in October 2022.

Trial registration number: ISRCTN14911850.

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来源期刊
Stroke and Vascular Neurology
Stroke and Vascular Neurology Medicine-Cardiology and Cardiovascular Medicine
CiteScore
11.20
自引率
1.70%
发文量
63
审稿时长
15 weeks
期刊介绍: Stroke and Vascular Neurology (SVN) is the official journal of the Chinese Stroke Association. Supported by a team of renowned Editors, and fully Open Access, the journal encourages debate on controversial techniques, issues on health policy and social medicine.
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