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Very Early Nimodipine Use in Stroke - VENUS
Description:
VENUS was a multicenter, randomized, double-blind, placebo-controlled study conducted in The Netherlands to evaluate the effect of nimodipine in acute stroke.
Hypothesis:
Early treatment with nimodipine will be associated with improvements in survival and functional outcome after stroke.
Study Design
Study Design:
Patients Enrolled: 454
Mean Follow Up: Three months
Mean Patient Age: 18-85
Female: 40
Patient Populations:
Patients with acute stroke presenting to general practitioners or neurologists
Exclusions:
Age <18 or >85, ability to raise arm or leg >10 seconds against gravity (to exclude patients unlikely to have stroke), inability to start treatment within six hours, previous participation in this trial, pregnancy, impaired consciousness, other diseases likely to cause death within one year, previous stroke resulting in serious handicap (Modified Rankin Score >3), dysphagia, systolic blood pressure <130 mm Hg, heart rate <50 bpm, and >3 of the following: severe headache, vomiting, systolic blood pressure >220 mm Hg, or use of oral anticoagulants
Primary Endpoints:
All-cause mortality or dependency in daily life (Modified Rankin Score >3) assessed three months after inclusion
Secondary Endpoints:
Neurologic status and blood pressure 24 hours after inclusion, mortality at 10 days, and adverse events
Drug/Procedures Used:
Patients were randomized to either nimodipine 30 mg orally every six hours for 10 days or matching placebo.
Principal Findings:
The study was planned for 1,500 patients. After enrollment of 454 patients, the trial was terminated early when an interim analysis failed to show a positive benefit of nimodipine therapy. The baseline characteristics for the groups were well matched in terms of age, gender, history of prior stroke or cardiac disease, and type of stroke.
The incidence of the primary endpoint was similar for both groups (32% for nimodipine and 27% for placebo, relative risk [RR] 1.2, confidence interval [CI] 0.9-1.6). Twenty-four hours after randomization, no significant differences in blood pressure or neurological status were detected between groups. Ten-day mortality was similar for both groups (6% nimodipine and 9% placebo, RR 0.7, CI 0.4-1.4). Subgroup analyses showed no differences in outcomes in patients with ischemic or hemorrhagic stroke.
Interpretation:
Among patients with stroke, treatment with nimodipine was not associated with improvements in survival or functional outcome when administered early in acute stroke. Conclusions from the trial are limited given that the trial was discontinuted prematurely for futility.
References:
Horn J, de Haan RJ, Vermeulen M, Limburg M. Very Early Nimodipine Use in Stroke (VENUS): a randomized, double-blind, placebo-controlled trial. Stroke 2001;32:461-5.
Keywords: Risk, Stroke, Intracranial Hemorrhages, Nimodipine, Blood Pressure, Medical Futility, Confidence Intervals
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