title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials (NCT): NCT01031667.
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.
authors.forename: Young-Guk
authors.initials: YG
authors.lastname: Ko
authors.forename: Byeong-Keuk
authors.initials: BK
authors.lastname: Kim
authors.forename: Byoung Kwon
authors.initials: BK
authors.lastname: Lee
authors.forename: Woong Chol
authors.initials: WC
authors.lastname: Kang
authors.forename: Seung Hyuk
authors.initials: SH
authors.lastname: Choi
authors.forename: Sang Wook
authors.initials: SW
authors.lastname: Kim
authors.forename: Jong Ho
authors.initials: JH
authors.lastname: Lee
authors.forename: Myoungsook
authors.initials: M
authors.lastname: Lee
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Honda
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Fitzerald
authors.forename: Won-Heum
authors.initials: WH
authors.lastname: Shim
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D000077407:Cilostazol; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011341:Probucol / Q000627:therapeutic use*; D056910:Republic of Korea; D012107:Research Design; D015607:Stents; D013777:Tetrazoles / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D000924:Anticholesteremic Agents; D015415:Biomarkers; D018836:Inflammation Mediators; D008055:Lipids; D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D000077407:Cilostazol; D011341:Probucol