Cilostazol in Acute Ischemic Stroke Treatment (CAIST)

Otsuka

Status and phase

Completed

Phase 4

Conditions

Cerebral Infarction

Treatments

Drug: Aspirin

Drug: Cilostazol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00272454

KOP-PLT-0501

Details and patient eligibility

About

The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.

Full description

Stroke is a leading cause of death and elderly disability in developed countries. However, treatment of acute stroke is limited except thrombolytic therapy in hyperacute stroke within several hours. Currently, aspirin is widely used in spite of its small benefit compared to bleeding complications.

Cilostazol will be compared to aspirin in acute stroke patients in terms of functional outcome at 3 months, efficacy to prevent stroke recurrence, and safety for bleeding complications.

Enrollment

468 estimated patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who receive explanation on this study and give informed consent
Patients aged 30 to 85 years
Baseline NIHSS less than 15
Onset of symptoms within 48 hours of the start of investigational product
Full functional independence prior to the present stroke indicated by an mRS score of 0, 1, 2

Exclusion criteria

Evidence from CT or MRI scan of an acute intracranial hemorrhage, a tumor, encephalitis or any diagnosis other than acute ischemic stroke likely to cause the present symptoms.
Previous regular use of an antiplatelet agent or warfarin
Patients with known cardiac disease likely to cause cardiogenic embolism or congestive heart failure
Evidence from CT or MRI scan of midline shift when visiting hospital
Uncontrolled hypertension (SBP>220 mmHg or DBP>120 mmHg)
Hypotension (<90/60 mmHg)
Patients with known bleeding diathesis or coagulation disorder
Patients with liver disease (ALT>100 or AST>100), or renal disease (creatinine>2.0 mg/dl)
Known severe anaemia (hemoglobin<8.0 mg/dl), or thrombocytopenia (platelet<100,000/mm3)
Scheduled for endarterectomy within 3 months
Severe co-morbidity likely to limit patient's life expectancy to less than 6 months
Patients with alcohol or illegal drug abuse or dependency
Pregnant or lactating patients. When administrating to females, it should be confirmed that the patients is in the menopause (by evaluation of investigators) or permanently infertile (hysterectomy or surgical operation like bilateral tubal ligation, bilateral oophorectomy, etc). If a patient is likely to be pregnant, the patient should not be pregnant before randomization. And, the patient should use reliable contraception between at least 3 weeks before randomization to 7 days after the final administration of study drug.
Patients treated by thrombolytic agents like tPA after onset of stroke