Recently Completed

Recently Completed

Primary Clinical Trial Publications

Precision
Nissen, S.E., Yeomans, N.D., Solomon, D.H., Lüscher, T.F., Libby, P., Husni, M.E., Graham, D.Y., Borer, J.S., Wisniewski, L.M., Wolski, K.E. and Wang, Q. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis. New England Journal of Medicine, 375 (2016), pp.2519-2529.

Glagov
Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JP, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE.  Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients.  The GLAGOV Randomized Clinical Trial. JAMA. Published online November 15, 2016. doi:10.1001/jama.2016.16951

Gauss-3
Nissen SE, Stroes E, Dent-Acosta RE, Rosenson RS, Lehman SJ, Sattar N, Preiss D, Bruckert E, Ceska R, Lepor N, Ballantyne CM, Gouni-Berthold I, Elliot M, Brennan DM, Wasserman SM, Somaratne R, Scott R, Stein EA, for the GAUSS-3 Investigators.  Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance.  The GAUSS-3 Randomized Clinical Trial.  JAMA. 2016; 315(15):1580-1590.  doi:10.1001/jama.2016.3608. Published online April 3, 2016

Light
Nissen, Steven E., Kathy E. Wolski, Lisa Prcela, Thomas Wadden, John B. Buse, George Bakris, Alfonso Perez, and Steven R. Smith. Effect of naltrexone-bupropion on major adverse cardiovascular events in overweight and obese patients with cardiovascular risk factors: a randomized clinical trial. JAMA 315, no. 10 (2016): 990-1004.

Assure
Nicholls, Stephen J., Rishi Puri, Kathy Wolski, Christie M. Ballantyne, Philip J. Barter, H. Bryan Brewer, John JP Kastelein et al. Effect of the BET protein inhibitor, RVX-208, on progression of coronary atherosclerosis: results of the phase 2b, randomized, double-blind, multicenter, ASSURE trial. American Journal of Cardiovascular Drugs 16, no. 1 (2016): 55-65.

Consulting

Cremer PC, Wu Y, Ahmed HM, Pierson LM, Brennan DM, Al-Mallah MH, Brawner CA, Keteyian SJ, Blumenthal RS, Blaha MJ, Cho L.  Sex-Specific Clinical and Exercise Risk Scores Better Identify Patients at Increased Risk for All-Cause Mortality: A Retrospective Cohort Study with External Validation.  JAMA Cardiol.  doi:10.1001/jamacardio.2016.3720.

Puri R, Nicholls SJ, John JS, Tuzcu EM, Kapadia SR, Uno K, Kataoka Y, Wolski K, Nissen SE. Comparing Coronary Atheroma Progression Rates and Coronary Events in the United States, Canada, Latin America, and Europe. The American Journal of Cardiology. 2016 Dec 1;118(11):1616-23.

Elshazly MB, Nicholls SJ, Nissen SE, St John J, Martin SS, Jones SR, Quispe R, Stegman B, Kapadia SR, Tuzcu EM, Puri R.  Implications of Total to High-Density Lipoprotein Cholesterol Ratio Discordance With Alternative Lipid Parameters for Coronary Atheroma Progression and Cardiovascular Events.  American Journal of Cardiology. 2016 Sep 1; 118(5): 647-55.

Sylvan J, Brier C, Wolski K, Yanof J, Goel V, Kuramochi Y, Eagleton MJ. Impact of alterations in target vessel curvature on branch durability after endovascular repair of thoracoabdominal aortic aneurysms. Journal of vascular surgery. 2016 Mar 31;63(3):634-41.

Madder RD, Puri R, Muller JE, Harnek J, Götberg M, VanOosterhout S, Chi M, Wohns D, McNamara R, Wolski K, Madden S. Confirmation of the Intracoronary Near-Infrared Spectroscopy Threshold of Lipid-Rich Plaques That Underlie ST-Segment–Elevation Myocardial Infarction. Arteriosclerosis, thrombosis, and vascular biology. 2016 May 1;36(5):1010-5.

Mani P, Uno K, Duong M, Wolski K, Spalding S, Husni E, Nicholls SJ. HDL function and subclinical atherosclerosis in juvenile idiopathic arthritis. Cardiovascular Diagnosis and Therapy. 2016 Jan 26;6(1):34-43.

Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. Journal of Vascular Surgery. 2016 Jan 11.
 
Puri R, Nissen SE, Shao M, Elshazly MB, Kataoka Y, Kapadia SR, Tuzcu EM, Nicholls SJ. Non-HDL cholesterol, triglycerides and remnant cholesterol: implications for coronary atheroma progression and clinical events. Arterioscler Thromb Vasc Biol. Accepted

Hussein AA, Baghdy Y, Wazni OM, Brunner MP, Kabbach G, Shao M, Gordon S, Saliba WI, Wilkoff BL, Tarakji KG. Microbiology of Cardiac Implantable Electronic Device Infections. JACC Clinical Electrophysiology. In Press.
 
Bassiouny M, Saliba W, Hussein A, Rickard J, Diab M, Aman W, Dresing T, Callahan T, Bhargava M, Martin D, Shao M, Baranowski B, Tarakji K, Tchou P, Hakim A, Kanj M,  Lindsay BD, Wazni O. Randomized study of Persistent Atrial Fibrillation Ablation: Ablate in Sinus Rhythm versus Ablate Complex Fractionated Atrial Electrograms in Atrial Fibrillation. Circ Arrhythm Electrophysiol. 9(2):e003596, 2016 Feb 9.
 
Hammadah M, Qintar M, Nissen SE, St John J, Alkharabsheh S, Mobolaji-Lawal M, Philip F, Uno K, Kataoka Y, Babb B, Poliszczuk R, Kapadia SR, Tuzcu EM, Schoenhagen P, Nicholls SJ, Puri R.  Non-invasive Volumetric Assessment of Aortic Atheroma: A Core Laboratory Validation Using Computed Tomography Angiography.  International Journal of Cardiovascular Imaging.  2016 Jan;32(1):121-9.

Results from Previous Trials

Results from Previous Trials

Cardiovascular Outcomes

VISTA-16 Varespladib sPLA2 inhibitor 2014 JAMA
dal – Outcomes Dalcetrapib CETP inhibitor 2012 NEJM
TRACER Vorapaxar (PAR-1) Thrombin-Receptor Antagonist 2012 NEJM
CRESCENDO Rimonabant Cannabanoid Receptor Antagonist 2010 LANCET
PPAR Rosiglitazone PPAR Agent 2007 AHJ
CAMELOT Amlodipine (Novasc®) Anti-Hypertensive 2004 JAMA
GUSTO IV - ACS Abcixmab (ReoPro®) GP IIb/IIIa Inhibitor 2001 LANCET
GUSTO IV - ACS Abcixmab (ReoPro®) GP IIb/IIIa Inhibitor 2001 LANCET

Antiplatelet

GP IIB/IIIa Inhibitors
CHARISMA Clopiogrel (Plavix®) GP IIb/IIIa Ihibitor 2006 NEJM
FINESSE Abcixmab (ReoPro®) GP IIb/IIIa Inhibitor 2008 NEJM
CREDO Clopiogrel (Plavix®) GP IIb/IIIa Ihibitor 2002 JAMA
SYMPHONY Sibrafiban GP IIb/IIIa Inhibitor 2000 LANCET
GUSTO V Abcixmab (ReoPro®) GP IIb/IIIa Inhibitor 2002 JAMA
EPIC Eptifibatide (Integrilin®) GP IIb/IIIa Inhibitor 1994 AJC

Thrombin Inhibition

CHOOSE Bivalirudin (Angiomax®) Direct Thrombin Inhibitor 2014 Ann Thorac Surg
REPLACE-2 Bivalirudin (Angiomax®) Direct Thrombin Inhibitor 2006 AHJ
EVOLUTION-ON Bivalirudin (Angiomax®) Direct Thrombin Inhibitor 2006 J Thorac Cardiovasc
EVOLUTION-OFF Bivalirudin (Angiomax®) Direct Thrombin Inhibitor 2006 J Thorac Cardiovasc
CACHET Bivalirudin (Angiomax®) Direct Thrombin Inhibitor 2002 AHJ

Atherosclerosis Progression

AQUARIUS Aliskerin Anti-hypertensive 2003 JAMA
SATURN Rosuvastatin (Crestor®) Statin 2011 NEJM
PERISCOPE Pioglitazone (ACTOS®) TZD 2008 JAMA
STRADIVARIUS Rimonabant Cannabanoid Receptor Antagoist 2008 JAMA
ILLUSTRATE Torcetrapib CETP Inhibitor 2007 NEJM
ASTEROID Rosuvastatin (Crestor®) Statin 2006 JAMA
ACTIVATE CS-505 ACAT Inhibitor 2006 AHJ
REVERSAL Atorvastatin (Lipitor®) Statin 2005 NEJM
NORMALISE Amlodipine (Novasc®) Calcium Channel Blocker 2004 JAMA
ApoA1 Milano ETC-216 ApoA1 protein 2003 JAMA

Diabetes

STAMPEDE Bariatric Surgery Surgical Therapy 2012 2012

Heart Failure

Ascend HF Nesiritide Recombinant BNP 2011 NEJM

Heart Transplantation

TICTAC Tacrolimus and MMF Immunosuppression 2011 Circ HF
ACCELERATE Data Transparency Initiative

ACCELERATE Data Transparency Initiative

Eli Lilly, in collaboration with the Cleveland Clinic Coordinating Center for Clinical Research (C5Research), will provide access to the individual patient data from the ACCELERATE trial to enable the advancement of cardiovascular research. Proposals will be accepted beginning May 2018. This access is provided in a timely fashion after the primary publication. Researchers must have an approved research proposal to gain access to the trial's patient data.

Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Most Recent Publication

ADCY9 Genetic Variants and Cardiovascular Outcomes with Evacetrapib in Patients with High Risk
Vascular Disease A Nested Case-Control Study

JAMA Cardiology, published online March 11, 2018

Primary Publication

Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease

N Engl J Med 2017;376:1933-42