Published Online: March 31, 2008 (doi:10.1001/jama.299.13.1561).
Author Contributions: Dr Nissen had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Nissen, Nesto, Kupfer, Perez, Tuzcu.
Acquisition of data: Nissen, Kupfer, Perez, Jure, De Larochellière, Staniloae, Mavromatis, Saw, Tuzcu.
Analysis and interpretation of data: Nissen, Nicholls, Wolski, Nesto, Kupfer, Perez, Hu, Lincoff, Tuzcu.
Drafting of the manuscript: Nissen.
Critical revision of the manuscript for important intellectual content: Nissen, Nicholls, Wolski, Nesto, Kupfer, Perez, De Larochellière, Jure, Staniloae, Mavromatis, Saw, Hu, Lincoff, Tuzcu.
Statistical analysis: Nissen, Wolski, Nesto, Hu.
Obtained funding: Nissen, Perez, Tuzcu.
Administrative, technical, or material support: Nissen, Nicholls, Kupfer, Perez, De Larochellière, Saw, Lincoff, Tuzcu.
Study supervision: Nissen, Kupfer, Perez, Mavromatis.
Financial Disclosures: Dr Nissen reports that the Cleveland Clinic Coordinating Center for Clinical Research has received research support to perform clinical trials from Pfizer, Astra Zeneca, Sankyo, Takeda, sanofi-aventis, Lilly, Roche, Daiichi-Sankyo, and Novartis. Dr Nissen consults for many pharmaceutical companies, but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction. Dr Nicholls reports receiving honoraria from Pfizer, AstraZeneca, Takeda, and Merck Schering-Plough, consultancy fees from AstraZeneca, Pfizer, Roche, Novo-Nordisk, Liposcience, and Anthera Pharmaceuticals and research support from AstraZeneca and Lipid Sciences. Dr Lincoff reports receiving research support to perform clinical trials through the Cleveland Clinic Coordinating Center for Clinical Research from Takeda, sanofi-aventis, Eli Lilly, Pfizer, Centocor, Dr Reddy's Laboratory, Medicines Company, Roche, Daiichi-Sankyo, Schering-Plough, Scios, and Astra-Zeneca. Dr Lincoff reports that he consults for a number of pharmaceutical companies, but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor tax deductions. Drs Kupfer and Perez are employees of Takeda. Dr Nesto reports receiving honoraria from GlaxoSmithKline, Takeda, Merck, Pfizer, and sanofi-aventis. Dr Saw reports receiving honoraria from sanofi-aventis, GlaxoSmithKline, and Cordis. Ms Wolski reports no relationships. Dr Tuzcu reports receiving consultancy fees from Pfizer and honoraria from Pfizer and Merck.
Funding/Support: This study was financially supported by Takeda Pharmaceuticals North America Inc.
Role of the Sponsor: The sponsor participated in discussions regarding study design and protocol development and provided logistical support during the trial. Monitoring of the study was performed by the sponsor, who also maintained the trial database. The IVUS end points were determined by the Cleveland Clinic Coordinating Center for Clinical Research. Statistical analyses were independently performed by both the sponsor and the coordinating center and the results cross-checked by statisticians with both organizations. The manuscript was prepared by the corresponding author and modified after consultation with the other authors. The sponsor was permitted to review the manuscript and suggest changes, but the final decision on content was exclusively retained by the academic authors. The study contract specified transfer of a copy of the study database to the coordinating center for independent analysis and granted the academic authors the unrestricted rights to publish the results.
Independent Statistical Analysis: An independent statistical analysis was conducted by Kathy Wolski, MPH, from the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation. Ms Wolski received the trial database from the sponsor, which included all the raw data, not just derived datasets; and independently computed the IVUS efficacy parameters, safety measures, laboratory parameters, and demographic variables. Ms Wolski is employed by the Cleveland Clinic Cardiovascular Coordinating Center, which received compensation from the sponsor for conducting the trial, including reimbursement for statistical services.
An additional independent statistical analysis was performed by Bo Hu, PhD, from the Department of Quantitative Health Sciences at Cleveland Clinic. Dr Hu is also an adjunct assistant professor in the Department of Statistics at Case Western Reserve University. Dr Hu received the entire trial database and independently confirmed Ms Wolski's findings. Dr Hu received compensation from the coordinating center, but not from the sponsor, for statistical services. The results reported in this article are based on the independent analyses.
Investigators and Committees of the Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation (PERISCOPE) Trial
Executive Committee: Steven E. Nissen, MD (Chair), Cardiovascular Medicine, Cleveland Clinic, Ohio; Richard Nesto, MD, Lahey Clinic, Burlington, Massachusetts; Ralph D’Agostino Sr, PhD, Boston University, Boston, Massachusetts; Alfonso Perez, MD, Takeda Global Research and Development Center, Deerfield, Illinois (nonvoting).
Steven M. Haffner, MD, University of Texas Health Science Center, San Antonio, was a member of the Executive Committee until November 2007, when he was asked to resign.
Data and Safety Monitoring Board: Edward Horton, MD, Boston, Massachusetts; George Bakris, MD, University of Chicago, Chicago, Illinois; Sidney Goldstein, MD, Henry Ford Hospital, Detroit, Michigan; Barry Davis, MD, PhD, University of Texas School of Public Health, Houston; Spencer King, MD, Fuqua Heart Center, Atlanta, Georgia, James Harper, PhD, Omnicare Clinical Research, Covington, Kentucky.
Clinical End Point Committee: William Gaasch, MD (Chairman) Director, Cardiovascular Research, Lahey Clinic, Burlington, Massachusetts; I. K. Jang, MD, Mass General Hospital, Boston, Massachusetts; Ajit B. Raisinghani, MD, University of California San Diego Medical Center, San Diego; Ori Ben-Yehuda, MD, University of California San Diego Medical Center, San Diego; Theo Meyer, MD, University of Massachusetts Medical Center, Worcester.
In addition to the authors, the following investigators participated in this study:
United States:Alabama: University of Alabama at Birmingham Hospital, V. Misra; California: Diabetes and Lipid Management Center, Huntington Beach, P. Rosenblit; LAC-USC Medical Center, Los Angeles, R. Sarma; UCLA Interventional Cardiology Research, Los Angeles, J. Tobis; Mercy Heart Institute, Sacramento, K. Singh; Naval Medical Center, San Diego, J. Cavendish, C. Ledford; San Diego VA Medical Center, W. Penny; University of California San Diego Medical Center, E. Mahmud; St Joseph's Medical Center, Stockton, H. Madyoon; Los Angeles Biomedical Research, Torrance, M. Budoff; Connecticut: Cardiology Associates of Southern Connecticut, Bridgeport, C. Landau; University of Connecticut Health Center, Farmington, M. Azrin; District of Columbia: George Washington University Hospital, J. Reiner; Florida: Bay Pines VA Medical Center, T. Theodoropoulos, M. Vandormael; Jacksonville Center for Clinical Research, M. Koren; University of Florida Health Sciences Center, Jacksonville, M. Costa; Georgia: Atlanta VA Medical Center, Decatur, K. Mavromatis; Indiana: Cardiovascular Clinics, PC, Merrillville, T. Nguyen; Kentucky: St Elizabeth Medical Center, Edgewood, D. Courtade; University of Kentucky Medical Center, Lexington, K. Ziada; University of Louisville, S. Ikram, M. Leesar; Louisiana: Ochsner Clinic Foundation, New Orleans, S. Ramee, J. Reilly; Maine: Northeast Cardiology Associates, Bangor, M. Rowe; Cardiovascular Consultants of Maine, Scarborough, W. Dietz; Michigan: McLaren Hospital, Flint, A. DeFranco, W. Rivera; Borgess Research Institute, Kalamazoo, T. Fischell; Cardiology Consultants, PC, Petoskey, H. Colfer; St Joseph Mercy Medical Center – Oakland, Pontiac, K. Patel; William Beaumont Hospital, Royal Oak, C. Grines; Michigan Cardiovascular Institute, Saginaw, R. Gudipati; Michigan Heart, PC, Ypsilanti, B. McCallister; Minnesota: Abbott Northwestern Hospital, Minneapolis, I. Chavez; St Mary's Duluth Clinic Health System, A. Deibele; Central Minnesota Heart Center, St Cloud, B. Erickson; Missouri: University of Missouri Hospitals and Clinics, Columbia, R. Webel; New Jersey: Cooper Health System, Camden, S. Werns; New York: Capital Cardiology Associates, Albany, A. DeLago; Montefiore Medical Center, Bronx, V. Srinivas; StVincent's Hospital-Manhattan, C. Staniloae; Winthrop University Hospital, Mineola, T. Kerwin; Mt Sinai Medical Center, New York, B. Baliga, R. Yanagisawa; Southbay Cardiovascular Associates, West Islip, P. Lee; Buffalo Cardiology and Pulmonary Associates, Williamsville, J. Corbelli; Ohio: University Hospitals of Cleveland, R. Nair; The Ohio State University Medical Center, Columbus, R. Magorien; University of Cincinnati, T. Helmy, S. A. Najeed, J. Schmidt; North Ohio Heart Center, Westlake, I. Ahmed; Oklahoma: Southwest Cardiology Associates, Oklahoma City, M. Yasin; Oklahoma VA Medical Center, Oklahoma City, E. Schechter; University of Oklahoma Health Sciences Center, Oklahoma City, J. Saucedo; Oklahoma Heart Institute, Tulsa, W. Leimbach; Pennsylvania: Bryn Mawr Hospital, J. Martin; Milton S. Hershey Medical Center, Hershey, M. Kozak; University of Pittsburgh Medical Center, O. Marroquin; Rhode Island: Rhode Island Hospital, Providence, B. Sharaf. South Carolina: Upstate Cardiology PA, Greenville, S. Johnson; Texas: Amarillo Heart Group, Amarillo, E. Rivera; Houston Northwest Medical Center, Houston, H. S. Bhatia, I. Lieber; Texas Cardiac Center, Lubbock, F. Shoukfeh; University of Texas Health Science Center, San Antonio, M. Feldman; Tennessee: Knoxville Cardiovascular Group, Knoxville, D. Wortham; VA Memphis, K. B. Ramanathan, Parkway Cardiology Associates, Oak Ridge, M. Sharma; Virginia: University of Virginia Health System, Charlottesville, M. Ragosta; Sentara Norfolk General Hospital, R. Stine; Hunter Holmes McGuire VA Medical Center, Richmond, A. Minisi; Washington: The Everett Clinic, Everett, P. Huang, M. Mulumudi; and Wisconsin: Cardiology Associates, Green Bay, D. Jenny.
Canada:Alberta: University of Alberta Hospital, Edmonton, J. Burton; British Columbia: Vancouver Hospital and Health Sciences Center, C. Buller, J. Saw; Victoria Heart Institute, J. D. Hilton; Manitoba: Health Sciences Centre, Winnipeg, J. Ducas; New Brunswick: St John Regional Hospital, R. Teskey; Ontario: London Health Sciences Centre, W. Kostuk; University of Ottawa Heart Institute, M. LeMay; and Quebec: Montreal: Institut de Cardiologie de Montreal, R. Bonan; CHUM–Hopital Saint-Luc, A. Kokis; Chum – Hopital Notre-Dame, F. Reeves; Hopital du Sacre-Coeur de Montreal, M. Doucet; Hopital Maisonneuve-Rosemont, C. Constance; and Sainte Foy: Hopital Laval, R. De Larochellière.
South America: Argentina:Buenos Aires: Instituto Cardiovascular de Buenos Aires, J. Belardi; Sanatorio Mitre, E. Blumberg; Sanatorio Guemes, G. Bortman; Hospital Italiano, A. Fernandez; Instituto Dupuytren, P. Kantor; Hospital Britanico de Buenos Aires, C. Majul; Fundacion Favaloro, O. Mendiz; Instituto Alexander Fleming, A. Pocovi; Cordoba: Hospital Privado, M. Amuchastegui; Sanatorio Allende, L. Guzman; Sanatorio Parque, H. Luquez; Clinica Chutro, H. Jure.
Chile:Santiago: Hospital Clinico de la Pontificia Universidad Catolica de Chile, R. Corbalan, E. Guarda; Hospital Clinico de la Universidad de Chile, G. Dussaillant; and Hospital San Juan de Dios, A. Bellet.
Additional Contributions: We thank the following individuals in conducting this study: Takeda Global Research and Development: Brigit Isaacson, MT (ASCP), MBA, Pat Naughton, RN, MS, Yinzhong Chen, PhD, and Andrew Roberts, MS. Cleveland Clinic Coordinating Center for Clinical Research: Craig Balog, BS, and Amy Hsu, MS. Cleveland Clinic Intravascular Ultrasound-Angiography Core Laboratory: Sorin Brener, MD, Tim Crowe, BS, William Magyar, BS, Jordan Andrews, BS, Eva Balazs, BS, Tammy Churchill, BS, Anne Colagiovanni, BS, Kelly Emerick, BS, Jessica Fox, BA, Teresa Fonk, BS, Tom Ivanc, MS, Karilane King, MS, Aaron Loyd. BS, Erin Mayock, BS, Kara McInturff, BS, Roman Poliszczuk, BS, Rhiannon Regal, BS, Andrea Winkhart, BS, and Jay Zhitnik, BS. The Cleveland Clinic employees did not receive any specific compensation for participation in this clinical trial.