| Abstrakt: |
Objective: We assessed the efficacy of minocycline in improving outcomes in acute ischemic stroke patients.Method: This was a multicenter, randomized, double-blind, placebo-controlled clinical trial, where acute ischemic stroke patients were randomized to either oral minocycline or placebo within 3 to 48 hours of symptom onset. The primary endpoint was the modified Rankin (mRS) score at day 90. Secondary outcomes included the National Institutes of Health Stroke Scale (NIHSS) scores, the Barthel index, and vascular outcomes at day 90.Results: A total of 139 subjects (73.4% male; mean age 62 [range 19-88] years) were randomized to receive minocycline (n = 69) or placebo (n = 70). At day 90, no significant difference was noted in the proportion of subjects given minocycline with mRS score ≤1 compared to placebo (56% versus 51%). The odds ratio of favorable outcome in the minocycline group compared to placebo was 1.20 (95% CI [0.58, 2.47], P= 0.60). No difference was recorded between the 2 groups in secondary outcomes of the NIHSS score (OR 1.11: 95% CI [0.98, 2.54]), the Barthel index (OR 0.78: 95% CI [0.33, 1.86]), or vascular events (OR 2.09 95% CI [0.29, 23.77]). A planned interim analysis was performed after approximately half the subjects reached the primary endpoint. The data and safety monitoring board recommended ending the trial for futility after determining that it was highly unlikely for minocycline to show significant efficacy over placebo in improving functional outcomes at day 90 if all subjects were randomized. No safety concerns were identified.Interpretation: Oral minocycline administered for acute ischemic stroke was ineffective in improving functional outcomes. |
