Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention
NCT ID: NCT00938522
Last Updated: 2009-07-21
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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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2009-07-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cilostazol loading
Cilostazol
Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the cilostazol group received 200 mg of cilostazol (loading dose) 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months.
Placebo
Placebo
Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the placebo group received 200 mg of placebo 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months.
Interventions
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Cilostazol
Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the cilostazol group received 200 mg of cilostazol (loading dose) 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months.
Placebo
Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the placebo group received 200 mg of placebo 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months.
Eligibility Criteria
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Inclusion Criteria
* Presence of coronary lesions amenable to stent
Exclusion Criteria
* Urgent PCI
* Hypersensitivity to aspirin, clopidogrel, or cilostazol
* LVEF \< 30% or congestive heart failure
* Bleeding diathesis
* leukocyte count \< 3,000/mm3 and/or platelet count \< 100,000/mm3
* aspartate aminotransferase or alanine aminotransferase \> 3 times upper normal; serum creatinine \> 2.0 mg/dl
* noncardiac disease with a life expectancy \< 1 year
* inability to follow the protocol
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Samsung Medical Center
Principal Investigators
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Hyeon-Cheol Gwon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2009-06-031
Identifier Type: -
Identifier Source: org_study_id
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