NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000129

Registered date:13/09/2005

Post-marketing study of cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison with Aspirin

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPatients with cerebral infarction (excluding cardiogenic cerebral embolism)
Date of first enrollment2003/12/01
Target sample size2600
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Cilostazol 200 mg group: Two 50-mg tablets of cilostazol and one aspirin placebo tablet will be administered after a meal in the morning, and two 50-mg tablets of cilostazol, after a meal in the evening. Duration of treatment: Minimum of 1 year and maximum of 5 years Aspirin 81 mg group: One 81-mg tablet of aspirin and two cilostazol placebo tablets will be administered after a meal in the morning, and two cilostazol placebo tablets, after a meal in the evening. Duration of treatment: Minimum of 1 year and maximum of 5 years

Outcome(s)

Primary OutcomeOccurrence of cerebral stroke (cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria(1)Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction (2)Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI (3)Patients aged 20 to 80 years (inclusive) at time of consent (4)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 (5)Patients without asymptomatic cerebral infarction (6)Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction (7)Patients without severe disturbances/impairments following occurrence of cerebral
Exclude criteria(1)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) (2)Pregnant, possibly pregnant, or nursing women (3)Patients with ischemic heart failure (4)Patients with peptic ulcer (5)Patients with severer blood disorders (6)Patients with severe hepatic or renal (7)Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study (8)Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets (9)Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma (10)Patients who are being treated with ticlopidine hydrochloride (11)Patients who are participating in another study for an investigational drug(12)Patients who are otherwise judged inappropriate for inclusion in the study by the investigators

Related Information

Contact

public contact
Name
Address Japan
Telephone
E-mail otsuka-com@umin.ac.jp
Affiliation Otsuka Pharmaceutical Co., Ltd. Department of Clinical and Research Development
scientific contact
Name Yukito Shinohara
Address 4-2-22, Nishiki-cho, Tachikawa, Tokyo, 190-8531, Japan Japan
Telephone
E-mail
Affiliation Federation of National Personnel Mutual Aid Associations, Tachikawa Hospital Internal Medicine