Vinpocetine treatment in acute ischaemic stroke: a pilot single-blind randomized clinical trial.
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.
Feigin
V L
VL
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
Doronin
B M
BM
Popova
T F
TF
Gribatcheva
E V
EV
Tchervov
D V
DV
D000208:Acute Disease; D000368:Aged; D002545:Brain Ischemia / Q000150:complications*; D003911:Dextrans / Q000737:chemistry / Q000627:therapeutic use; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008970:Molecular Weight; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D010865:Pilot Projects; D012720:Severity of Illness Index; D016037:Single-Blind Method; D020521:Stroke / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D016896:Treatment Outcome; D014748:Vinca Alkaloids / Q000627:therapeutic use*
D003911:Dextrans; D004338:Drug Combinations; D018696:Neuroprotective Agents; D014748:Vinca Alkaloids; C013983:vinpocetine