Vinpocetine treatment in acute ischaemic stroke: a pilot single-blind randomized clinical trial

Authors

  • V. L. Feigin,

    1. Department of Epidemiology and Preventive Medicine, Institute of Internal Medicine, Siberian Branch of the Russian Academy of Medical Science, Novosibirsk, Russia;
    2. Clinical Trials Research Unit, University of Auckland, New Zealand; and
    Search for more papers by this author
  • B. M. Doronin,

    1. Department of Neurology and Neurosurgery, Novosibirsk Medical University, Novosibirsk, Russia
    Search for more papers by this author
  • T. F. Popova,

    1. Department of Neurology and Neurosurgery, Novosibirsk Medical University, Novosibirsk, Russia
    Search for more papers by this author
  • E. V. Gribatcheva,

    1. Department of Neurology and Neurosurgery, Novosibirsk Medical University, Novosibirsk, Russia
    Search for more papers by this author
  • D. V. Tchervov

    1. Department of Epidemiology and Preventive Medicine, Institute of Internal Medicine, Siberian Branch of the Russian Academy of Medical Science, Novosibirsk, Russia;
    Search for more papers by this author

Associate Professor Valery Feigin, Clinical Trials Research Unit, Private Bag 92019, University of Auckland, New Zealand (fax: 649 3731710; e-mail: v.feigin@ctru.auckland.ac.nz).

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.

Ancillary