Methodology of Clinical Trials in Acute Cerebral Ischemia

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Abstract
The lack of efficacy proof explains that there is no standard therapy for acute stroke. If we consider the stroke incidence and the number of drugs tested and developed in this indication for more than 30 years, what are the difficulties to reach therapeutic efficacy? The first is patient selection: hemorrhage and ischemia are not candidates for the same therapy; for cerebral infarcts, therapeutic implications are often specific of the etiologic mechanism (arterial embolism, thrombosis with developed atheroma, hypertensive microangiopathy). The right selection depends oh clinical criteria for stroke diagnosis before any emergency strategy; on imaging criteria (computed tomography and magnetic resonance imaging) for more precise type, area and extension of cerebral damage, and on cerebrovascular criteria (Doppler, arteriography) for stroke mechanism. Hemodynamic and metabolic criteria are of great interest but have no direct application for therapeutic trials. The second difficulty is the assessment of therapeutic effect. Survival can be the main criteria only for severe strokes. Neurological recovery assessment is difficult and can be comparative only for similar patterns of deficits. Functional recovery assessment is possible with validated scales but is more sensitive to confusion factors. Measuring the infarction size with neuro-imaging after the early stage is a promising approach but procedure and device standardization are still limiting factors, especially for multicenter trials.

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