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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Samsung Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00938522
First received: July 13, 2009
Last updated: July 20, 2009
Last verified: July 2009

July 13, 2009
July 20, 2009
July 2009
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00938522 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention
PREtreatment of Cilostazol Loading in Elective Percutaneous Coronary Intervention to Decrease Adverse Events

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Angioplasty, Transluminal, Percutaneous Coronary
  • 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.
  • 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.
  • Experimental: Cilostazol loading
    Intervention: Drug: Cilostazol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
400
October 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
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
 
NCT00938522
2009-06-031
Yes
HC Gwon, MD, PhD, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Hyeon-Cheol Gwon, MD, PhD Samsung Medical Center
Samsung Medical Center
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP