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Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention (PRECEDE)

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ClinicalTrials.gov Identifier: NCT00938522
Recruitment Status : Unknown
Verified July 2009 by Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 14, 2009
Last Update Posted : July 21, 2009
Sponsor:
Information provided by:
Samsung Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Angioplasty, Transluminal, Percutaneous Coronary Drug: Cilostazol Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PREtreatment of Cilostazol Loading in Elective Percutaneous Coronary Intervention to Decrease Adverse Events
Study Start Date : July 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Cilostazol
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Late loss on quantitative coronary angiography [ Time Frame: 9 months after index PCI ]
  2. % neointimal area [100 x (stent area-lumen area)/stent area] on IVUS [ Time Frame: 9 months after index PCI ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: HC Gwon, MD, PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00938522     History of Changes
Other Study ID Numbers: 2009-06-031
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: July 21, 2009
Last Verified: July 2009

Keywords provided by Samsung Medical Center:
Cilostazol loading
Angioplasty, Transluminal, Percutaneous Coronary

Additional relevant MeSH terms:
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors