Back to resultsCilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction. (CSPS)
Primary Purpose
Cerebral Infarction
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
cilostazol
placebo of cilostazol
Sponsored by
About this trial
This is an interventional prevention trial for Cerebral Infarction
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
cilostazol
placebo
Arm Description
cilostazol oral tablet 100 mg, twice daily
placebo of cilostazol, twice daily
Outcomes
Primary Outcome Measures
Recurrence of cerebral infarction
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00766545
First Posted
October 2, 2008
Last Updated
February 25, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00766545
Brief Title
Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.
Acronym
CSPS
Official Title
Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 1992 (undefined)
Primary Completion Date
March 1997 (Actual)
Study Completion Date
March 1997 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1095 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cilostazol
Arm Type
Experimental
Arm Description
cilostazol oral tablet 100 mg, twice daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo of cilostazol, twice daily
Intervention Type
Drug
Intervention Name(s)
cilostazol
Intervention Description
oral tablet 100 mg, twice daily, over 1 year
Intervention Type
Drug
Intervention Name(s)
placebo of cilostazol
Intervention Description
oral tablet, 0 mg twice daily, over 1 year
Primary Outcome Measure Information:
Title
Recurrence of cerebral infarction
Time Frame
any time
Secondary Outcome Measure Information:
Title
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
Time Frame
any time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Kanto Area
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.
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