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

NCT00766545 | Completed Phase 3 DMC

• 1 other identifier: 021-91-001
• Study Type: interventional
• Target: 1,095
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

• Recurrence of cerebral infarction

  any time

Secondary Outcomes (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

Study Arms (2)

cilostazol

EXPERIMENTAL

cilostazol oral tablet 100 mg, twice daily

Drug: cilostazol

placebo

PLACEBO COMPARATOR

placebo of cilostazol, twice daily

Drug: placebo of cilostazol

Interventions

cilostazol DRUG

oral tablet 100 mg, twice daily, over 1 year

cilostazol

placebo of cilostazol DRUG

oral tablet, 0 mg twice daily, over 1 year

placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kanto Area, Japan

Location

MeSH Terms

Conditions

Cerebral Infarction

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 6, 2008
• Study Start: April 1, 1992
• Primary Completion: March 1, 1997
• Study Completion: March 1, 1997
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

JP (1)