Email updates

Keep up to date with the latest news and content from Trials and BioMed Central.

Open Access Study protocol

Study design and rationale of "Synergistic Effect of Combination Therapy with Cilostazol and ProbUcol on Plaque Stabilization and Lesion REgression (SECURE)" study: a double-blind randomised controlled multicenter clinical trial

Young-Guk Ko1, Byeong-Keuk Kim18, Byoung Kwon Lee2, Woong Chol Kang3, Seung Hyuk Choi4, Sang Wook Kim5, Jong Ho Lee6, Myoungsook Lee7, Yasuhiro Honda8, Peter J Fitzerald8, Won-Heum Shim1* and SECURE Investigators12345678

  • * Corresponding author: Won-Heum Shim whshim@yuhs.ac

  • † Equal contributors

Author Affiliations

1 Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea

2 Gangnam Severance Hospital, Yonsei University Health System, Seoul, Korea

3 Gil Medical Center, Gachon University, Incheon, Korea

4 Samsung Medical Center, Sungkyunkwan University, Seoul, Korea

5 Chung-Ang University Hospital, Seoul, Korea

6 National Research Laboratory for Clinical Nutrigenetics/Nutrigenomics, Yonsei University, Seoul, Korea

7 Laboratory of Nutritional Medicine/Nutrigenomics, Sungshin Women's University, Seoul, Korea

8 Cardiac Core Analysis Laboratory at Stanford University Medical Center, Stanford, CA, USA

For all author emails, please log on.

Trials 2011, 12:10  doi:10.1186/1745-6215-12-10

Published: 12 January 2011

Abstract

Background

Probucol, a cholesterol-lowering agent that paradoxically also lowers high-density lipoprotein cholesterol has been shown to prevent progression of atherosclerosis. The antiplatelet agent cilostazol, which has diverse antiatherogenic properties, has also been shown to reduce restenosis in previous clinical trials. Recent experimental studies have suggested potential synergy between probucol and cilostazol in preventing atherosclerosis, possibly by suppressing inflammatory reactions and promoting cholesterol efflux.

Methods/design

The Synergistic Effect of combination therapy with Cilostazol and probUcol on plaque stabilization and lesion REgression (SECURE) study is designed as a double-blind, randomised, controlled, multicenter clinical trial to investigate the effect of cilostazol and probucol combination therapy on plaque volume and composition in comparison with cilostazol monotherapy using intravascular ultrasound and Virtual Histology. The primary end point is the change in the plaque volume of index intermediate lesions between baseline and 9-month follow-up. Secondary endpoints include change in plaque composition, neointimal growth after implantation of stents at percutaneous coronary intervention target lesions, and serum levels of lipid components and biomarkers related to atherosclerosis and inflammation. A total of 118 patients will be included in the study.

Discussion

The SECURE study will deliver important information on the effects of combination therapy on lipid composition and biomarkers related to atherosclerosis, thereby providing insight into the mechanisms underlying the prevention of atherosclerosis progression by cilostazol and probucol.

Trial registration number

ClinicalTrials (NCT): NCT01031667