Post-Marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)

Condition(s) targeted: Cerebral Infarction

Intervention: Cilostazol (Drug); Aspirin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Otsuka Pharmaceutical Co., Ltd.

Official(s) and/or principal investigator(s):
Katsuhisa Saito, Study Director, Affiliation: Division of New Product Evaluation and Development

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).

Official title: Post-Marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion 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

Exclusion 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

Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan

Starting date: December 2003
Ending date: December 2008
Last updated: April 23, 2008