Clinical Research Directory

Butylphthalide for Long-term Efficacy in Minor Stroke Study

This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the long-term efficacy and safety of butylphthalide in patients with minor acute ischemic stroke (BLESS Trial). A total of 1200 participants aged 40 to 80 years with a minor acute ischemic stroke confirmed by MRI will be enrolled. Participants will be randomly assigned in a 1:1 ratio to receive butylphthalide or placebo for 12 months. The primary outcome is a hierarchical composite endpoint assessed at 12 months, including: 1. All-cause mortality 2. Stroke recurrence 3. Modified Rankin Scale (mRS) score ≥2 4. New MRI-confirmed infarcts 5. Change in Montreal Cognitive Assessment (MoCA) score from baseline Secondary outcomes include additional functional, cognitive, and imaging-based assessments at 12 months. This study aims to determine whether butylphthalide can improve long-term functional and cognitive outcomes in patients with minor ischemic stroke, contributing to better secondary stroke prevention strategies.

Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions

In a randomized controlled trial the effect of 12 weeks of cross-sectorial physical exercise combined with patient education and individual follow-up session is investigated in patients with minor stroke or non-disabling stroke.

Early-phase Telecare Programs for Minor Stroke

Minor strokes (few acute neurological symptoms ; NIHSS score \<5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Most patients with minor stroke are rapidly discharged from hospital, with follow-up focused on secondary prevention and they are offered little or no rehabilitation. However, up to 70% of patients with minor stroke experience difficulties resuming their social or professional activities, which can lead to social and economic disruption (delayed/compromised return to work) and an increased risk of depression. While some care recommendations exist for this population, in France there is no consensus nor identified care pathway for follow-up assessment or management of these patients. Furthermore, existing services are unevenly distributed across the country, and research into the effectiveness of rehabilitation is still scarce, leading to uncertainty as to which interventions should be prioritized to decrease difficulties related to cognitive impairment. Since there are currently no rehabilitation proposals in France for patients with mild cognitive impairment after mild stroke, in this trial the investigaror will investigate the effectiveness of two six-week telerehabilitation programs each consisting of a weekly session supervised by a therapist and a self-rehabilitation session. The aim of this multicenter randomized controlled trial is the evaluate the relevance and feasibility of early identification of patients eligible for a cognition-focused management proposal and the efficacy of two telecare programs, (a) psychoeducation and (b) computerized cognitive rehabilitation.