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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 13, 2009

Last Updated Date

July 20, 2009

Start Date ^ICMJE

July 2009

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00938522 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention

Official Title ^ICMJE

PREtreatment of Cilostazol Loading in Elective Percutaneous Coronary Intervention to Decrease Adverse Events

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Angioplasty, Transluminal, Percutaneous Coronary

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Cilostazol loading
Intervention: Drug: Cilostazol
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

October 2011

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00938522

Other Study ID Numbers ^ICMJE

2009-06-031

Has Data Monitoring Committee

Yes

Responsible Party

HC Gwon, MD, PhD, Samsung Medical Center

Study Sponsor ^ICMJE

Samsung Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hyeon-Cheol Gwon, MD, PhD

Samsung Medical Center

Information Provided By

Samsung Medical Center

Verification Date

July 2009

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

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