Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention - Full Text View

Sponsor:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00938522

Purpose

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
Angioplasty, Transluminal, Percutaneous Coronary	Drug: Cilostazol Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	PREtreatment of Cilostazol Loading in Elective Percutaneous Coronary Intervention to Decrease Adverse Events

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Heart Attack

Drug Information available for: Cilostazol

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization) [ Time Frame: at 3 months after PCI ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Late loss on quantitative coronary angiography [ Time Frame: 9 months after index PCI ] [ Designated as safety issue: No ]
% neointimal area [100 x (stent area-lumen area)/stent area] on IVUS [ Time Frame: 9 months after index PCI ] [ Designated as safety issue: No ]
Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization) [ Time Frame: 12 months after index PCI ] [ Designated as safety issue: Yes ]

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
Experimental: Cilostazol loading	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.
Placebo Comparator: Placebo	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.

Arms

Assigned Interventions

Experimental: Cilostazol loading

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.

Placebo Comparator: Placebo

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients undergoing elective PCI
Presence of coronary lesions amenable to stent

Exclusion Criteria:

Cardiogenic shock
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938522

Contacts

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

Locations

Korea, Republic of
Samsung Medical Center	Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyeon-Cheol Gwon, MD, PhD 82-2-3410-3418 hc.gwon@samsung.com

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:

Hyeon-Cheol Gwon, MD, PhD

Samsung Medical Center

More Information

No publications provided

Responsible Party:	HC Gwon, MD, PhD, Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00938522 History of Changes
Other Study ID Numbers:	2009-06-031
Study First Received:	July 13, 2009
Last Updated:	July 20, 2009
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

Cilostazol loading
Angioplasty, Transluminal, Percutaneous Coronary

Additional relevant MeSH terms:

Cilostazol
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents

Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 12, 2012