treatment in acute ischaemic stroke.
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. email@example.com
Eur J Neurol 2001 Jan;8(1):81-5
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.