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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Cerebral Infarction

Treatments: Drug: cilostazol; Drug: placebo of cilostazol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00766545

021-91-001

Details and patient eligibility

About

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.

Enrollment: 1,095 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,095 participants in 2 patient groups, including a placebo group

cilostazol

Experimental group

Description:

cilostazol oral tablet 100 mg, twice daily

Treatment:

Drug: cilostazol

placebo

Placebo Comparator group

Description:

placebo of cilostazol, twice daily

Treatment:

Drug: placebo of cilostazol