Overview

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

Status:
Completed
Trial end date:
1997-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Treatments:
Cilostazol
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