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
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Details
1 Yonsei University Health System, Severance Cardiovascular Hospital, Seoul, South Korea (GRID:grid.413046.4)
2 Yonsei University Health System, Severance Cardiovascular Hospital, Seoul, South Korea (GRID:grid.413046.4); Cardiac Core Analysis Laboratory at Stanford University Medical Center, Stanford, USA (GRID:grid.240952.8) (ISNI:0000000087342732)
3 Yonsei University Health System, Gangnam Severance Hospital, Seoul, South Korea (GRID:grid.413046.4)
4 Gachon University, Gil Medical Center, Incheon, South Korea (GRID:grid.256155.0) (ISNI:0000000406472973)
5 Sungkyunkwan University, Samsung Medical Center, Seoul, South Korea (GRID:grid.264381.a) (ISNI:000000012181989X)
6 Chung-Ang University Hospital, Seoul, South Korea (GRID:grid.411651.6) (ISNI:0000000406474960)
7 Yonsei University, National Research Laboratory for Clinical Nutrigenetics/Nutrigenomics, Seoul, South Korea (GRID:grid.15444.30) (ISNI:0000000404705454)
8 Sungshin Women's University, Laboratory of Nutritional Medicine/Nutrigenomics, Seoul, South Korea (GRID:grid.264383.8) (ISNI:000000012175669X)
9 Cardiac Core Analysis Laboratory at Stanford University Medical Center, Stanford, USA (GRID:grid.240952.8) (ISNI:0000000087342732)