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

Cerebral Infarction Clinical Trial

— CSPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766545
• Other study ID #: 021-91-001
• Status: Completed
• Phase: Phase 3
• Start date: April 1992
• Est. completion date: March 1997

Study information

• Verified date: February 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1095
• Est. completion date: March 1997
• Est. primary completion date: March 1997
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• cilostazol
oral tablet 100 mg, twice daily, over 1 year
• placebo of cilostazol
oral tablet, 0 mg twice daily, over 1 year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of cerebral infarction		any time
Secondary	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