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.
