Search

Rationale Recurrent stroke is prevalent and associated with high mortality rates, disability, and social and economic costs. Adequate management of risk factors may reduce recurrent stroke; however, many stroke survivors have poor control of risk factors. We have developed a theoretically sound and evidence-based lifestyle modification program called the Stroke Coach, a telephone-based self-management program to improve control of risk factors. Hypothesis Individuals who participate in Stroke Coach will achieve more lifestyle improvements than individuals in an attention controlled Memory Training Program. Design In this single blind randomized controlled trial, 126 community-living stroke survivors will be randomized to Stroke Coach or the attention control group. Participants randomized to the six-month Stroke Coach will receive seven telephone lifestyle coaching sessions, self-management education and practice, and a self-monitoring kit, comprised of a health report card, with blood pressure and activity monitors. Study Outcomes The primary outcome will be measured using the Health Promoting Lifestyle Profile II. Secondary outcomes include behavioral and physiological risk factors, quality of life, cognitive status, health and social service use. Measurements will be taken at baseline, immediately after the intervention and six-month post-intervention. Summary The results of this trial will add to our understanding of the use of self-management to improve control of risk factors, and may facilitate the development of a larger trial evaluating the effect of Stroke Coach on endpoints such as recurrent stroke or cardiac events as the primary outcome.

Rationale Patients with transient ischemic attack or minor stroke are at high risk of early recurrent cerebrovascular events. Anticoagulation with heparin or warfarin acutely after ischemic stroke is at least as efficacious as aspirin for preventing recurrent events but is associated with an increased risk of clinical worsening due to hemorrhagic transformation. Aim and hypothesis We aim to demonstrate the safety of early anticoagulation with dabigatran, an oral direct thrombin inhibitor, in acute cerebrovascular syndrome patients. The primary hypothesis is that symptomatic hemorrhagic transformation rates in dabigatran and aspirin-treated patients will be similar. Sample size estimates At least 136 participants in two groups required to demonstrate an absolute between-group difference in the rate of hemorrhagic transformation of 5.6% with 80% power, assuming alpha = 5%. Methods and design A randomized, multicenter open-label clinical trial (NCT02295826). Three-hundred participants with a transient ischemic attack/ischemic stroke (National Institutes of Health Stroke Scale ≤ 9) will undergo magnetic resonance imaging within 72 h of symptom onset and will be randomized to aspirin 81 mg daily or dabigatran 150 mg twice daily for 30 days. Participants undergo repeat magnetic resonance imaging at 30 days and clinical assessment to 90 days. Study outcomes The primary outcome is the symptomatic hemorrhagic transformation rate. Secondary outcomes include recurrent stroke and new ischemic lesions on repeat magnetic resonance imaging. Discussion This study will determine the safety of early anticoagulation with dabigatran in patients with acute transient ischemic attack/ischemic stroke and will inform the design of a phase III randomized trial aimed at demonstrating reduced recurrent early ischemic events after acute transient ischemic attack/stroke.

Background Neuroimaging manifestations of small vessel disease are heterogeneous, and correlation with patient features has not been adequately characterized. Aim Our goal was to correlate magnetic resonance imaging findings with clinical features in a large multiethnic cohort with recent lacunar stroke. Methods Patient characteristics were correlated with neuroimaging results in the Secondary Prevention of Small Subcortical Stroke study participants. Results Among 3005 patients, mean age was 63 years; 62% were men; and 51%, 30%, and 16% were non-Hispanic White, Hispanic, and Black, respectively. Recent lacunar infarcts were distributed between the subcortical hemisphere (31%), thalamus (26%), brainstem/cerebellum (26%), and basal ganglia/internal capsule (16%). Multiple lacunar infarcts (i.e., acute and remote) were present in 40% and associated with increased age (OR 1·3 per 20 years, 95% CI 1·1, 1·5), male gender (OR 1·5, CI 1·3, 1·7), hypertension (OR 1·5, CI 1·2, 1·8), increased systolic blood pressure (OR 1·2 per 20 mmHg, CI 1·1, 1·3), and prior stroke (OR 3·8, CI 2·9, 5·0). Moderate-severe white matter hyperintensities were present in 50% and associated with increased age (OR 4·3 per 20 years, CI 3·4, 5·4), hypertension (OR 1·8, CI 1·4, 2·3), increased systolic blood pressure (OR 1·3 per 20mmHg, CI 1·1, 1·5), increased diastolic blood pressure (OR 1·2 per 10 mm, CI 1·0,1·3), and prior stroke (OR 3·3, CI 2·3, 4·5). Infarct location varied significantly by race-ethnicity ( P < 0·001), with Blacks and Hispanics having more infarcts in the brainstem/cerebellum than non-Hispanic Whites, and by gender with women more often having thalamic lacunes than men ( P ≤ 0·001). Conclusions In patients with recent lacunar stroke, infarct location and number have distinctie associations with gender, vascular risk factors, and race-ethnicity, demonstrating the complex pathogenesis of lacunar stroke and cerebral small artery disease.

Background It remains controversial whether dual antiplatelet therapy reduces stroke more than aspirin alone. Aim We aimed to assess the effects of adding clopidogrel to aspirin on the occurrence of stroke and major haemorrhage in patients with vascular disease. Methods Meta-analysis of published randomized trials comparing the combination of clopidogrel and aspirin vs. aspirin alone that reported stroke and major bleeding. Results Thirteen randomized trials were included with a total of 90 433 participants (mean age 63 years; 63% male) with a mean follow-up of 1·0 years and 2011 strokes. Stroke was reduced 19% by dual antiplatelet therapy (odds ratio = 0·81, 95% confidence interval 0·74–0·89) with no evidence of heterogeneity of effect across different trial populations (I2 index = 5%, P = 0·4 for heterogeneity). Dual antiplatelet therapy reduced ischemic stroke by 23% (odds ratio = 0·77; 95% confidence interval 0·70–0·85); there was a nonsignificant 12% increase in intracerebral haemorrhage (odds ratio = 1·12, 95% confidence interval 0·86–1·46). Among 1930 participants with recent (Conclusions This meta-analysis demonstrates a substantial relative risk reduction in stroke by clopidogrel plus aspirin vs. aspirin alone that is consistent across different trial cohorts. Major haemorrhage is increased by dual antiplatelet therapy.

Background Small subcortical strokes, also known as lacunar strokes, comprise more than 25% of brain infarcts, and the underlying vasculopathy is the most common cause of vascular cognitive impairment. How to optimally prevent stroke recurrence and cognitive decline in S3 patients is unclear. The aim of the Secondary Prevention of Small Subcortical Strokes study (Trial registration: NCT00059306) is to define strategies for reducing stroke recurrence, cognitive decline, and major vascular events. Methods Secondary Prevention of Small Subcortical Strokes is a randomised, multicentre clinical trial ( n=3000) being conducted in seven countries, and sponsored by the US NINDS/NIH. Patients with symptomatic small subcortical strokes in the six-months before and an eligible lesion on magnetic resonance imaging are simultaneously randomised, in a 2 × 2 factorial design, to antiplatelet therapy – 325 mg aspirin daily plus 75 mg clopidogrel daily, vs. 325 mg aspirin daily plus placebo, double-blind – and to one of two levels of systolic blood pressure targets –‘intensive’ (Conclusions Secondary Prevention of Small Subcortical Strokes will address several important clinical and scientific questions by testing two interventions in patients with recent magnetic resonance imaging-defined lacunar infarcts, which are likely due to small vessel disease. The results will inform the management of millions of patients with this common vascular disorder.