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Completed

NCT Number: NCT00766545

Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.

The multi-center, double-blind, placebo-controlled, randomized, group-comparison study was designated to assess the long-term safety and efficacy of the antiplatelet drug cilostazol in preventing the recurrence of cerebral infarction in patients who had suffered a cerebral infarction 1 to 6 months prior to entering the trial.

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kanto Area, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prior cerebral infarction Onset at 1 to 6 months before randomization
  • CT or MRI detection of responsible site
  • Without serious complications (malignant tumor, liver cirrhosis, renal failure, or heart failure)

Exclusion criteria

  • History of intracranial hemorrhage
  • Possibility of cardiogenic cerebral embolism in the past or future All patients with any of the following complications were excluded: mitral valve stenosis, prosthetic valve, endocarditis, myocardial infarction within 6 weeks after onset, ventricular aneurysm, intraventricular or intraatrial blood clots, mitral valve prolapsed (age under 45 years old, lacking other causes for cerebral embolism induction), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy
  • Severe cerebral deficits rendering the patient bed-ridden, totally dependent, or demented
  • Contraindications to the study drug Hemostatic disorders or systemic bleeding Pregnant or possibly pregnant women, or nursing mothers
  • Requirement for nonstudy antiplatelet drugs, anticoagulant drugs, or fibrinolytic drugs for another disease

Treatment and study plan

Cilostazol

Drug

oral tablet 100 mg, twice daily, over 1 year

placebo of cilostazol

Drug

oral tablet, 0 mg twice daily, over 1 year

Primary outcomes

  1. Recurrence of cerebral infarction

    Time frame: any time

Secondary outcomes

  1. Cerebral infarction or myocardial infarction, Cerebral infarction, intracranial hemorrhage, or TIA, Cerebral infarction, intracranial hemorrhage, myocardial infarction, or vascular death, All vascular events, vascular death, and Death from any cause

    Time frame: any time

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Acronym: CSPS

Important dates

Study start
1992
Primary completion
1997
Study completion
1997
First posted
Oct 6, 2008
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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