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

Phase 3

Completed

• Conditions: Cerebral Infarction
• Interventions: Drug: placebo of cilostazol; Drug: cilostazol

• Registration Number: NCT00766545
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1992-04
• Primary Completion: 1997-03
• Study Completion: 1997-03
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1095

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo of cilostazol	placebo of cilostazol, twice daily
cilostazol	cilostazol	cilostazol oral tablet 100 mg, twice daily

Primary Outcome Measures

Name	Time	Method
Recurrence of cerebral infarction	any time

Secondary Outcome Measures

Name	Time	Method
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	any time