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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Samsung Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938522
First Posted: July 14, 2009
Last Update Posted: July 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Samsung Medical Center
  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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]

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

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.

  Eligibility

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
  Contacts and Locations
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
  More Information

Responsible Party: HC Gwon, MD, PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00938522     History of Changes
Other Study ID Numbers: 2009-06-031
First Submitted: July 13, 2009
First Posted: July 14, 2009
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