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Vinpocetine treatment in acute ischaemic stroke:
a pilot single-blind randomized clinical trial.
Feigin VL, Doronin BM, Popova TF, Gribatcheva EV, Tchervov DV.
Department of Epidemiology and Preventive Medicine,
Institute of Internal Medicine,
Siberian Branch of the Russian Academy of Medical Science, Novosibirsk, Russia. v.feigin@ctru.auckland.ac.nz
Eur J Neurol 2001 Jan;8(1):81-5
Abstract
The aim of the study was to assess the safety and feasibility of a clinical trial on the effect of vinpocetine, a synthetic ethyl ester of apovincamine, in acute ischaemic stroke. Thirty consecutive patients with computed tomography verified diagnosis of acute ischaemic stroke, who could receive drug treatment within 72 h of stroke onset, were enrolled. The patients were randomly allocated to receive either low-molecular weight dextran alone or in combination with
vinpocetine. Poor outcome was defined as being dead or having a Barthel index of < 70 or a Rankin score of 3--5. Intention-to-treat analysis was applied. One-tenth of all hospitalized patients with acute ischaemic stroke were eligible for the trial. Thirty eligible patients were treated with either low-molecular weight dextran alone (mean age 57.9 11.6 years, n = 15) or in combination with
vinpocetine (mean age 60.8 6.6 years, n = 15). The two treatment groups were comparable with respect to major prognostic variables. A relative risk (RR) reduction of poor outcome at 3 months follow-up was 30% (RR = 0.7; 95% confidence interval [CI] 0.1--3.4), as defined by the modified Barthel Index, and 60% as defined by the modified Ranking score (RR = 0.4, 95% CI: 0.1--1.7). The National Institute of Health (NIH--NINDS) Stroke Scale score was marginally significantly better in the
vinpocetine treated group at 3 months of follow-up (P = 0.05, ANOVA). No significant adverse effects were seen. This pilot study shows that a full-scale randomized double-blind, placebo-controlled trial of
vinpocetine treatment in acute ischaemic stroke is feasible and warranted. |
