Original Article
Cilostazol for the Prevention of Acute Progressing Stroke: A Multicenter, Randomized Controlled Trial

https://doi.org/10.1016/j.jstrokecerebrovasdis.2013.02.009Get rights and content

Background

Progressing stroke is one of the major determinants of outcome after acute ischemic stroke. A pilot randomized controlled trial was conducted to investigate the effect of cilostazol on progressing stroke.

Methods

Adult patients with noncardioembolic ischemic stroke within 24 hours after onset were randomized to receive cilostazol 200 mg/day (cilostazol group) or no medication (control group) in addition to the optimum medical treatments (a free radical scavenger plus an antiplatelet agent or an antithrombin agent). The primary endpoints were the rate of progressing stroke, defined as aggravation of the National Institutes of Health Stroke Scale (NIHSS) score by ≥4 points on days 3 and/or 5 and a modified Rankin Scale score of 0 to 1 at 3 months after enrollment. Aggravation caused by systemic complications, edema, hemorrhagic infarction, or recurrent stroke was not considered as progressing stroke. This trial was registered as UMIN000001630.

Results

A total of 510 patients were enrolled from 55 institutions in Japan between February 2009 and July 2010. The rate of progressing stroke was 3.2% and 6.3% in the cilostazol and control groups, respectively (P = .143). The modified Rankin Scale score of 0 to 1 at 3 months did not differ between the groups.

Conclusions

Cilostazol failed to show a preventive effect against acute progressing stroke. However, the tendency to reduce progressing stroke and the results of stratified analyses may encourage additional studies to clarify the effect of cilostazol in the treatment of acute ischemic stroke.

Section snippets

Patients

The present study included patients with acute noncardioembolic ischemic stroke. Subtypes of ischemic stroke were based on the National Institute of Neurological Disorders and Stroke III23 and judged by physicians in each hospital. Specifically, the definitive diagnosis of cardioembolic stroke is often difficult in the acute stage, so we tentatively defined cardioembolic stroke as infarction in areas of the cortical branches in patients with any heart disease that is a potential embolic source

Results

A total of 510 patients (340 men and 170 women with a mean age of 66.4 years) were enrolled from 55 institutions in Japan between February 2009 and July 2010. Two patients withdrew informed consent, and 1 patient did not return to the hospital and therefore received no treatment. Five hundred seven patients were included in the full analysis set. The cilostazol group consisted of 251 patients, of whom 238 patients were treated with 200 mg/day and 2 patients with 100 mg/day. Cilostazol was

Discussion

In the present study, the primary endpoint for mRS score did not show any significant difference between the cilostazol and control groups. The rates of progressing stroke also failed to show statistically significant effects of cilostazol (P = .143).

Patients with progressing stroke had a statistically significantly lower rate of mRS scores of 0 to 1 at 3 months after enrollment than those without progressing stroke (Table 3), suggesting that progressing stroke is one of the major influencing

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    • Cited by (0)

    Supported by Gonryo for the Promotion of Medical Science at Tohoku University Graduate School of Medicine, Sendai, Japan.

    Dr. Shimizu has received lecture fees from Sanofi-Aventis and Otsuka Pharmaceutical. Dr. Terayama has received lecture fees from Sanofi-Aventis and Otsuka Pharmaceutical and consultant fees from Sanofi-Aventis. Dr. Etsuro Mori has received lecture fees from Tanabe-Mitsubishi and consultant fees from Lundbeck.

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    Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved.