Trial | NCT00766545  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cilostazol ...

  • Study Participants

    1095
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.
Study Started
Apr 30
1992
Primary Completion
Mar 31
1997
Study Completion
Mar 31
1997
Last Update
Mar 01
2021

Drug cilostazol

oral tablet 100 mg, twice daily, over 1 year

Drug placebo of cilostazol

oral tablet, 0 mg twice daily, over 1 year

cilostazol Experimental

cilostazol oral tablet 100 mg, twice daily

placebo Placebo Comparator

placebo of cilostazol, twice daily

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
No Results Posted