title: Ten-year standardization of lipids and high-sensitivity C-reactive protein in a randomized controlled trial to assess the effects of statins on secondary stroke prevention: Japan Statin Treatment Against Recurrent Stroke.
abstract: Background The Japan Statin Treatment Against Recurrent Stroke (J-STARS) is a clinical trial that administered pravastatin for secondary stroke prevention. Lipid concentrations are a well-established risk factor for cerebrovascular diseases. Elevated high-sensitivity C-reactive protein (hs-CRP) indicates a high risk of inflammatory reactions. In clinical trials, internationally approved standardization is essential for obtaining study results that are comparable with those from overseas. Therefore, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) and hs-CRP were standardized throughout a 10-year study period. Methods J-STARS specified a single clinical laboratory for blood analyses. Four lipids were evaluated by calculating the total error: accuracy (absolute mean %bias vs. reference value) + precision (1.96 among-run coefficient of variation [CV, %]). Accuracy for hs-CRP was ensured using a calibrator traceable to the international plasma protein reference material and precision was evaluated by CV. Results Average total errors (standard deviation, %) throughout the study period were as follows: TC 1.35% (0.290%), HDL-C 2.45% (1.087%), LDL-C 2.65% (0.956%) and TG 3.70% (0.559%). Four lipids met the performance criteria of the US Centers for Disease Control and Prevention (CDC). The precision of hs-CRP was 3.28% (0.627%), which met the performance criterion established by the American Heart Association/CDC. Conclusions Based on standardization, the results of J-STARS appear to be comparable with those of similar intervention-based clinical studies on statins overseas. These study results will contribute to the establishment of preventive measures against recurrent stroke in Japanese patients. J-STARS is registered in ClinicalTrials.gov under NCT00221104.
authors.affiliation: 1 Lipid Reference Laboratory, Department of Preventive Cardiology, National Cerebral and Cardiovascular Center, Osaka, Japan.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: 2 Quality Assurance Department, SRL Inc., Tokyo, Japan.
authors.forename: Tatsuyuki
authors.initials: T
authors.lastname: Fukukawa
authors.affiliation: 3 Department of Neurology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Kitagawa
authors.affiliation: 4 Center for Clinical Research, Kobe University Hospital, Hyogo, Japan.
authors.forename: Yoji
authors.initials: Y
authors.lastname: Nagai
authors.affiliation: 5 Department of Clinical Neuroscience and Therapeutics, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
authors.forename: Naohisa
authors.initials: N
authors.lastname: Hosomi
authors.affiliation: 6 National Cerebral and Cardiovascular Center, Osaka, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Minematsu
authors.affiliation: 7 Clinical Research Center, International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center, Tokyo, Japan.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Uchiyama
authors.affiliation: 5 Department of Clinical Neuroscience and Therapeutics, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
authors.forename: Masayasu
authors.initials: M
authors.lastname: Matsumoto
authors.affiliation: 8 Department of Preventive Cardiology, National Cerebral and Cardiovascular Center, Osaka, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Miyamoto
mesh_terms: D000368:Aged; D002097:C-Reactive Protein / Q000378:metabolism*; D005260:Female; D008401:Gas Chromatography-Mass Spectrometry; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D057230:Limit of Detection; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D055502:Secondary Prevention; D020521:Stroke / Q000517:prevention & control*
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008055:Lipids; D002097:C-Reactive Protein
keywords: CDC; CRMLN; J-STARS; hs-CRP; lipids; standardization