Post-Marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2) - Full Text View

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00234065

Purpose

The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).

Condition	Intervention	Phase
Cerebral Infarction	Drug: Cilostazol Drug: Aspirin	Phase IV

Drug Information available for: Acetylsalicylic acid Cilostazol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Post-Marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Occurrence of cerebral stroke (cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage) [ Time Frame: every time ] [ Designated as safety issue: Yes ]

Enrollment:	2800
Study Start Date:	December 2003
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental cilostazol	Drug: Cilostazol oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years
2: Active Comparator Aspirin	Drug: Aspirin oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI
Patients aged 20 to 80 years (inclusive) at time of consent
Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale
Patients without asymptomatic cerebral infarction
Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
Patients without severe disturbances/impairments following occurrence of cerebral

Exclusion Criteria:

Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
Pregnant, possibly pregnant, or nursing women
Patients with ischemic heart failure
Patients with peptic ulcer
Patients with severer blood disorders
Patients with severe hepatic or renal
Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
Patients who are being treated with ticlopidine hydrochloride
Patients who are participating in another study for an investigational drug
Patients who are otherwise judged inappropriate for inclusion in the study by the investigators

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234065

Locations

Japan
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director:

Katsuhisa Saito

Division of New Product Evaluation and Development

More Information

Responsible Party:	OPCJ ( Katsuhisa Saito )
Study ID Numbers:	C02100-002, JapicCTI-050034, UMIN-CTR-C000000129
Study First Received:	October 4, 2005
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00234065
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Cilostazol
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases

Cerebrovascular Disorders
Recurrence
Necrosis
Aspirin
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Neuroprotective Agents
Fibrin Modulating Agents
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics

Nervous System Diseases
Cyclooxygenase Inhibitors
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Analgesics, Non-Narcotic
Autonomic Agents
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009