Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
468 participants
INTERVENTIONAL
2006-01-31
2008-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Cilostazol
Aspirin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
85 Years
ALL
No
Sponsors
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Seoul National University Boramae Hospital
OTHER
Korea Otsuka International Asia Arab Co., Ltd.
UNKNOWN
Korea Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Principal Investigators
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Yong-Seok Lee, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University
Locations
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Hallym University Sacred Heart Hospital
Ahnyang, Kyunggi Province, South Korea
Inje University Ilsan Paik Hospital
Koyang, Kyunggi Province, South Korea
Seoul National University Bundang Hospital
Sungnam, Kyunggi Province, South Korea
Eulji University Hospital
Daejeon, , South Korea
Inha University Hospital
Incheon, , South Korea
Dongguk University Hospital
Koyang, Kyunggi Province, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hallym University Kangdong Sacred Heart Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Eulji University Hospital
Seoul, , South Korea
Seoul National University Boramae Hospital
Seoul, , South Korea
Soonchunhyang University Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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KOP-PLT-0501
Identifier Type: -
Identifier Source: org_study_id
NCT00272129
Identifier Type: -
Identifier Source: nct_alias