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

• Sponsor: Otsuka Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00766545
• Collaborator: (none)
• Enrollment: 1,095
• Location: 1
• Arms: 2
• Duration (Months): 59
• Patients Per Site Per Month: 18.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Infarction	Drug: cilostazol; Drug: placebo of cilostazol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1095 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.
• Study Start Date: Apr 1, 1992
• Actual Primary Completion Date: Mar 1, 1997
• Actual Study Completion Date: Mar 1, 1997

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cilostazol cilostazol oral tablet 100 mg, twice daily	Drug: cilostazol; oral tablet 100 mg, twice daily, over 1 year
Placebo Comparator: placebo placebo of cilostazol, twice daily	Drug: placebo of cilostazol; oral tablet, 0 mg twice daily, over 1 year

Outcome Measures

Primary Outcome Measures

1. Recurrence of cerebral infarction [any time]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kanto Area		Japan

Sponsors and Collaborators

• Otsuka Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00766545
• Other Study ID Numbers: 021-91-001
• First Posted: Oct 6, 2008
• Last Update Posted: Mar 1, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Cerebral Infarction; Infarction; Cilostazol

Study Results

No Results Posted as of Mar 1, 2021