Clinical trial NCT00272454: Cilostazol in Acute Ischemic Stroke Treatment (CAIST)
Official title: The Double-Blind, Randomized, Multi-Center, and Active Controlled Trial for Efficacy and Safety of Cilostazol in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebral Infarction
Keywords: cilostazol
aspirin
cerebral infarction
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Boramae Hospital
name: Korea Otsuka International Asia Arab Co., Ltd.
First posted: 2006-01-06
Enrollment: 468
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the frequency of mRS 0, 1, 2 at 90 days
timeFrame: at 90 days
Secondary outcomes:
measure: Frequency of mRS 0,1 at 90 days
timeFrame: at 90 days
measure: Frequency of Barthel index 95-100 at 90 days
measure: Frequency of mRS 0,1 & Barthel index 95-100 at 90 days
measure: Frequency of NIHSS 0-1 at 90 days
measure: Frequency of progression of neurological deficit at 7 days (increment of NIHSS 2 points or a point on the item of upper or lower extremity weakness)
measure: Bleeding disorders (life-threatening bleeding; major bleeding; minor Bleeding)
measure: Overall cardiovascular events (Ischemic heart disease requiring rehospitalization)
Other outcomes:
Locations:
city: Ahnyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Kyunggi Province
city: Koyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Kyunggi Province
city: Sungnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyunggi Province
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Koyang, Kyunggi Province
country: Korea, Republic of
facility: Dongguk University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
Study officials:
affiliation: Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University
name: Yong-Seok Lee, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YS, Bae HJ, Kang DW, Lee SH, Yu K, Park JM, Cho YJ, Hong KS, Kim DE, Kwon SU, Lee KB, Rha JH, Koo J, Han MG, Lee SJ, Lee JH, Jung SW, Lee BC, Kim JS. Cilostazol in Acute Ischemic Stroke Treatment (CAIST Trial): a randomized double-blind non-inferiority trial. Cerebrovasc Dis. 2011;32(1):65-71. doi: 10.1159/000327036. Epub 2011 May 25.