Cilostazol Stroke Prevention Study : A Placebo-Controlled Double-Blind Trial for Secondary Prevention of Cerebral Infarction. - Full Text View

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00766545

Purpose

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.

Condition	Intervention	Phase
Cerebral Infarction	Drug: cilostazol Drug: placebo of cilostazol	Phase III

Drug Information available for: Cilostazol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Cilostazol Stroke Prevention Study : A Placebo-Controlled Double-Blind Trial for Secondary Prevention of Cerebral Infarction.

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Recurrence of cerebral infarction [ Time Frame: any time ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	1095
Study Start Date:	April 1992
Study Completion Date:	March 1997
Primary Completion Date:	March 1997 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
cilostazol: Experimental cilostazol oral tablet 100 mg, twice daily	Drug: cilostazol oral tablet 100 mg, twice daily, over 1 year
placebo: Placebo Comparator placebo of cilostazol, twice daily	Drug: placebo of cilostazol oral tablet, 0 mg twice daily, over 1 year

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766545

Locations

Japan

Kanto area, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

More Information

Study ID Numbers:	021-91-001
Study First Received:	October 2, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00766545
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Cilostazol
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases

Cerebrovascular Disorders
Necrosis
Neoplasm Metastasis
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Nervous System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Protective Agents
Neuroprotective Agents

Pharmacologic Actions
Fibrin Modulating Agents
Phosphodiesterase Inhibitors
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009