| 3 | Taking care of volunteers in a stroke trial: a new assisted-management strategy显示文摘Background and purpose:Providing participants with evidence-based care for secondary prevention is an ethical and scientific priority for trials in stroke therapy.The optimal strategy,however,is uncertain.We report the performance of a new approach for delivering preventive care to trial participants.Methods:Participants were enrolled in the Insulin Resistance Intervention after Stroke trial,which examined the insulin sensitiser,pioglitazone versus placebo for prevention of stroke and myocardial infarction after ischaemic stroke or transient ischaemic attack.Preventive care was the responsibility of the participants’personal healthcare providers,but investigators monitored care and provided feedback annually.We studied achievement of 8 prevention goals at baseline and 3 annual visits,with a focus on 3 priority goals:blood pressure<140/90 mm Hg,lowdensity lipoprotein(LDL)cholesterol<2.59 mmol/L and antithrombotic therapy.Results:The proportion of participants achieving the priority goals was highest for antithrombotic use(96–99%in each year)and similar for blood pressure(66–72%in each year)and LDL(68–70%in each year).All 3 priority goals were achieved by 47–52%of participants in any given year.However,only 22%of participants achieved all 3 goals in each year.Conclusions:A strategy of monitoring care and providing feedback was associated with high average yearly achievement of 3 priority secondary prevention goals,but the majority of trial participants did not persist in being at goal over time.Trial registration number:NCT00091949. | Amber C Stuart Jason J Sico Catherine M Viscoli Ashis H Tayal Silvio E Inzucchi Gary A Ford Karen L Furie Robert Cote J David Spence David Tanne Walter N Kernan on behalf of the IRIS Trial Investigators | 2016 | Stroke & Vascular Neurology2016，1，3： | 0 |
| 4 | 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)显示文摘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. | Philip M Bath Iris Mhlanga Lisa J Woodhouse Fergus Doubal Katherine Oatey Alan A Montgomery Joanna M Wardlaw LACI-Trial Investigators | 2023 | Stroke & Vascular Neurology2023，8，2： | 0 |
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