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

Information source: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cerebral Infarction

Intervention: cilostazol (Drug); placebo of cilostazol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Otsuka Pharmaceutical Co., Ltd.

Summary

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.

Clinical Details

Official title: Cilostazol Stroke Prevention Study : A Placebo-Controlled Double-Blind Trial for Secondary Prevention of Cerebral Infarction.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Recurrence of cerebral infarction

Secondary outcome: 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

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Prior cerebral infarction Onset at 1 to 6 months before randomization 2. CT or MRI detection of responsible site 3. Without serious complications (malignant tumor, liver cirrhosis, renal failure, or heart failure) Exclusion Criteria: 1. History of intracranial hemorrhage 2. 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 3. Severe cerebral deficits rendering the patient bed-ridden, totally dependent, or demented 4. Contraindications to the study drug Hemostatic disorders or systemic bleeding Pregnant or possibly pregnant women, or nursing mothers 5. Requirement for nonstudy antiplatelet drugs, anticoagulant drugs, or fibrinolytic drugs for another disease

Locations and Contacts

Kanto area, Japan
Additional Information

Starting date: April 1992
Last updated: January 8, 2009

Page last updated: August 23, 2015

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