Importance of proper patient selection and endpoint selection in evaluation of new therapies in acute stroke: further analysis of the SENTIS trial

Clinical Trials Sunday, January 13th, 2013

Jnis.bmj: January 3, 2013


Background The magnitude of treatment effect in acute stroke depends on several factors, including time from symptom onset (TFSO) to treatment and severity of the initial insult.

Objective To report further evaluation of NeuroFlo therapy, focusing on the effect of time and stroke severity.

Methods SENTIS was a prospective randomized trial (N=515) comparing standard medical therapy with/without NeuroFlo therapy. For this analysis, we evaluated outcomes in groups of patients based on TFSO and stroke severity: patients randomized <6 h, 6–10 h, and >10 h with mild (NIHSS<8), moderate (8–14), and severe (>14) symptoms at randomization. 90-Day mRS (modified Rankin Scale) scores and stroke-related death rates were compared between treatment groups. Read more

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