Cilostazol in Acute Ischemic Stroke Treatment (CAIST)
The Double-Blind, Randomized, Multi-Center, and Active Controlled Trial for Efficacy and Safety of Cilostazol in Acute Ischemic Stroke
1 other identifier
interventional
468
1 country
12
Brief Summary
The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2006
Typical duration for phase_4
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 3, 2006
CompletedFirst Posted
Study publicly available on registry
January 6, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedDecember 16, 2009
December 1, 2009
January 3, 2006
December 15, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of the frequency of mRS 0, 1, 2 at 90 days
at 90 days
Secondary Outcomes (7)
Frequency of mRS 0,1 at 90 days
at 90 days
Frequency of Barthel index 95-100 at 90 days
Frequency of mRS 0,1 & Barthel index 95-100 at 90 days
Frequency of NIHSS 0-1 at 90 days
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)
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Hallym University Sacred Heart Hospital
Ahnyang, Kyunggi Province, 431-070, South Korea
Inje University Ilsan Paik Hospital
Koyang, Kyunggi Province, 411-706, South Korea
Seoul National University Bundang Hospital
Sungnam, Kyunggi Province, 463-707, South Korea
Eulji University Hospital
Daejeon, 302-799, South Korea
Inha University Hospital
Incheon, 400-711, South Korea
Dongguk University Hospital
Koyang, Kyunggi Province, South Korea
Seoul National University Hospital
Seoul, 110-799, South Korea
Hallym University Kangdong Sacred Heart Hospital
Seoul, 134-701, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Eulji University Hospital
Seoul, 139-711, South Korea
Seoul National University Boramae Hospital
Seoul, 156-707, South Korea
Soonchunhyang University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 21613787DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong-Seok Lee, M.D., PhD
Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 3, 2006
First Posted
January 6, 2006
Study Start
January 1, 2006
Study Completion
September 1, 2008
Last Updated
December 16, 2009
Record last verified: 2009-12