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

UMIN ID: C000000129

Registered date:13/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with cerebral infarction (excluding cardiogenic cerebral embolism)
• Date of first enrollment: 2003/12/01
• Target sample size: 2600
• Countries of recruitment: Japan
• Study type: Interventional

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 Outcome: Occurrence of cerebral stroke (cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• 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

• Primary Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Source(s) of Monetary Support: Otsuka Pharmaceutical Co., Ltd.
• Secondary ID(s): NCT00234065,JapicCTI-050034