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.
Author(s): Ko YG, Kim BK, Lee BK, Kang WC, Choi SH, Kim SW, Lee JH, Lee M, Honda Y,
Fitzerald PJ, Shim WH; SECURE Investigators.
Affiliation(s): Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.
Publication date & source: 2011, Trials. , 12:10
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.
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