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

Otsuka

Status and phase: Completed; Phase 4

Conditions: Cerebral Infarction

Treatments: Drug: Aspirin; Drug: Cilostazol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00234065

UMIN-CTR-C000000129

JapicCTI-050034

C02100-002

Details and patient eligibility

About

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).

Enrollment: 2,800 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,800 participants in 2 patient groups

1

Experimental group

Description:

cilostazol

Treatment:

Drug: Cilostazol

2

Active Comparator group

Description:

Aspirin

Treatment:

Drug: Aspirin