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Sponsored by: |
Samsung Medical Center |
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Information provided by: | Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT00938522 |
The purpose of this study is to investigate the effect of cilostazol loading before planned PCI on major adverse cardiac and cerebrovascular events in patients with coronary artery disease.
Condition | Intervention | Phase |
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Angioplasty, Transluminal, Percutaneous Coronary |
Drug: Cilostazol Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | PREtreatment of Cilostazol Loading in Elective Percutaneous Coronary Intervention to Decrease Adverse Events |
Estimated Enrollment: | 400 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cilostazol loading: Experimental |
Drug: 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.
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Placebo: Placebo Comparator |
Drug: 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.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hyeon-Cheol Gwon, MD, PhD | 82-2-3410-3418 | hc.gwon@samsung.com |
Contact: Young Bin Song, MD, PhD | 82-2-3410-1333 | youngbin.song@gmail.com |
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 135-710 |
Principal Investigator: | Hyeon-Cheol Gwon, MD, PhD | Samsung Medical Center |
Responsible Party: | Samsung Medical Center ( HC Gwon, MD, PhD ) |
Study ID Numbers: | 2009-06-031 |
Study First Received: | July 13, 2009 |
Last Updated: | July 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00938522 History of Changes |
Health Authority: | South Korea: Institutional Review Board |
Cilostazol loading Angioplasty, Transluminal, Percutaneous Coronary |
Cilostazol Vasodilator Agents Anti-Asthmatic Agents Fibrinolytic Agents Cardiovascular Agents Neuroprotective Agents Fibrin Modulating Agents |
Phosphodiesterase Inhibitors Aspirin Clopidogrel Platelet Aggregation Inhibitors Peripheral Nervous System Agents Bronchodilator Agents |
Cilostazol Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Anti-Asthmatic Agents Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Protective Agents |
Neuroprotective Agents Pharmacologic Actions Fibrin Modulating Agents Phosphodiesterase Inhibitors Autonomic Agents Therapeutic Uses Platelet Aggregation Inhibitors Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |