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Updated: Aug 14, 2026

Optimized Management of Endovascular Treatment for Acute Ischemic Stroke
Published on: January 18, 2018
Cilostazol in secondary prevention of stroke: impact of the Cilostazol Stroke Prevention Study
1Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical Sciences, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan. mack@hiroshima-u.ac.jp
Insights
Cilostazol significantly reduces the risk of recurrent stroke by 41.7% compared to placebo, particularly in patients with lacunar infarction. This antiplatelet drug shows promise for secondary stroke prevention without increasing hemorrhage risk.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Clinical Trials
Background:
- Stroke is a leading cause of mortality in Japan, necessitating effective secondary prevention strategies.
- Current secondary stroke prevention involves managing cardiovascular risk factors and using antiplatelet drugs like aspirin and cilostazol.
- Aspirin, while effective for ischemic strokes, carries an increased risk of hemorrhagic infarction.
Purpose of the Study:
- To evaluate the efficacy of cilostazol in preventing secondary strokes compared to placebo.
- To assess the safety profile of cilostazol regarding intracranial hemorrhage.
- To investigate potential specific effects of cilostazol in patient subgroups, such as those with lacunar infarction.
Main Methods:
- A randomized, double-blind, placebo-controlled trial (Cilostazol Stroke Prevention Study) involving over 1000 Japanese patients.
- Comparison of secondary stroke event rates between patients receiving cilostazol and those receiving placebo.
- Analysis of specific endpoints, including cerebral infarction, intracranial hemorrhage, myocardial infarction, and vascular death.
Main Results:
- Cilostazol reduced the risk of secondary stroke by 41.7% compared to placebo (P = 0.015).
- A significant risk reduction of 43.4% was observed in patients with prior lacunar infarction (P = 0.0373), suggesting efficacy against small-vessel disease.
- Cilostazol demonstrated significant risk reductions in combined vascular endpoints and showed benefits in intent-to-treat analyses without increasing intracranial hemorrhage.
Conclusions:
- Cilostazol is effective in reducing the risk of secondary stroke, particularly in patients with a history of lacunar infarction.
- Cilostazol may act as a vascular neuroprotectant with a favorable safety profile concerning intracranial hemorrhage.
- Clinical implications are tempered by the study's use of placebo instead of aspirin as the comparator, the current standard of care.
Abstract:
According to recent epidemiological data in Japan, stroke affects roughly 5.3 males and 3.9 females per 1000 person-years and is the third leading cause of mortality. At present, management strategies for secondary prevention of stroke include aggressive treatment of cardiovascular risk factors (i.e., hypertension, smoking cessation, etc.). Antiplatelet drugs in Japan, namely aspirin and cilostazol, are utilized regularly for the prevention of secondary stroke. While aspirin is beneficial for a wide range of cardiovascular endpoints, including total and ischemic strokes, it is also associated with significantly increased risks for hemorrhagic infarction. Cilostazol, by contrast, has been shown to significantly reduce the risk of recurrent strokes without affecting the occurrence of intracranial hemorrhage. In the Cilostazol Stroke Prevention Study, a randomized double-blind, placebo-controlled trial involving more than 1000 Japanese patients, cilostazol was found to reduce the risk of secondary stroke by 41.7% compared with placebo, a statistically significant reduction (P = 0.015). The greatest risk reduction (43.4% in cilostazol versus placebo, P = 0.0373) was found in patients who initially had a lacunar infarction, suggesting that cilostazol has a specific effect against small-vessel disease. In addition, cilostazol achieved significant risk reductions on a number of combined endpoints (e.g., cerebral infarction, intracranial hemorrhage, myocardial infarction, or vascular death), and was associated with benefits in intent-to-treat analyses. These findings indicate that cilostazol may have a role as a vascular neuroprotectant, but the clinical implications are limited by the fact that patients were randomized to placebo instead of aspirin, which is the standard of care.
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