2018 – 2022

SOLOIST
Sanofi Aventis
Chair
RCT of sotagliflozin versus placebo in patients with diabetes and acute decompensated heart failure.

2018 – 2022

SCORED
Sanofi Aventis
Chair
RCT of sotagliflozin versus placebo in patients with diabetes and at high cardiovascular risk.

2011 – 2020

REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial)
Amarin
Chair and PI
This is an international, multicenter, trial of patients with cardiovascular risk or diabetes randomized to an ethyl-eicosapentaenoic acid or placebo. The purpose is to determine definitively whether triglyceride lowering does or does not reduce cardiovascular risk in patients receiving intensive statin therapy.

2010 – 2020

CHAMPION PHOENIX
Chiesi
Co-Chair and Co-PI
This is an industry-sponsored Phase 3 trial of cangrelor versus placebo in 11,000 patients undergoing percutaneous coronary intervention.

2014 – 2020

THEMIS
AstraZeneca
Co-Chair and co-PI
This is an international, multicenter, randomized trial of patients with diabetes and stable coronary artery disease randomized to the oral antiplatelet ticagrelor or to placebo on top of standard of care including aspirin.

2000 – 2003

CRUISE (Coronary Revascularization Using Integrilin and Single Bolus Enoxaparin)
Cor Therapeutics
Co-PI
This was a multicenter, randomized trial to evaluate the relative safety and efficacy of intravenous enoxaparin versus unfractionated heparin in patients undergoing percutaneous coronary intervention and receiving eptifibatide.

2000 – 2003

Enoxaparin in ACS Patients Undergoing Catheterization
Aventis (RhonePoulenc Rorer), Cleveland Clinic IRB # 3350
PI
This was a single center evaluation of the safety and ability to monitor the level of anticoagulation with intravenous enoxaparin given during percutaneous coronary intervention.

2002 – 2004

PPAR (Prevention of Adverse Events following Percutaneous Coronary Revascularization)
GlaxoSmithKline
PI
This was a multicenter, randomized trial of rosiglitazone versus placebo in patients with metabolic syndrome undergoing percutaneous coronary intervention. The goal was to see if there was any effect on plaque progression by examining carotid intimal medial thickness at one year.

2002 – 2006

CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance)
Sanofi-Aventis/Bristol-Myers Squibb
PI
This was an international, multicenter, randomized trial of clopidogrel versus placebo on top of background therapy with aspirin in patients with atherothrombosis or risk factors for atherothrombosis. The goal was to determine if the benefits of dual antiplatelet therapy would extend to patients at the lower end of the risk spectrum.

2005 – 2007

A Randomized Placebo-Controlled, Double-Blinded Trial to Study the Effects of
Supplementary Dietary Omega-3 Fatty Acids on Serum C-Reactive Protein Levels
Cleveland Clinic, IRB #6970
PI
This was a single center randomized trial of omega-3 fatty acids versus placebo in a primary prevention setting to determine any effect on C-reactive protein levels.

2005 – 2010

CRESCENDO (Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes)
Sanofi Aventis
PI
This was an international, multicenter, randomized trial of the weight loss drug rimonabant versus placebo to determine the effect on morbidity and mortality.

2006 – 2009

CHAMPION-PCI (A Clinical Trial to Demonstrate the Efficacy of Cangrelor)
The Medicines Company
Co-PI
This was an international, multicenter, randomized trial of the intravenous antiplatelet agent cangrelor versus 600 mg of clopidogrel in patients undergoing percutaneous coronary intervention to determine whether it was superior or at least non-inferior for reducing ischemic events.

2006 – 2009

CHAMPION-PLATFORM (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition)
The Medicines Company
Co-PI
This was an international, multicenter, randomized trial of the intravenous antiplatelet agent cangrelor versus placebo in patients undergoing percutaneous coronary intervention to determine whether it could reduce ischemic events.

2007 – 2010

COGENT (The Effect of Clopidogrel Plus Omeprazole Versus Clopidogrel on Gastrointestinal and ardiovascular Complications in Patients With Coronary Artery Disease)
Cogentus Pharmaceuticals
Co-PI
This was an international, multicenter, randomized trial of proton pump inhibition versus placebo in patients receiving dual antiplatelet therapy. The goal was to prove whether clinical gastrointestinal adverse events would be reduced and to determine if there was a cardiovascular interaction between clopidogrel and omeprazole.

2007 – 2010

LANCELOT CAD (Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease)
Eisai
PI
This was an international, multicenter, randomized Phase 2 trial of the PAR-1 receptor antagonist E5555 versus placebo in patients with stable coronary artery disease. The goal was to examine the safety and efficacy.

2007 – 2010

LANCELOT ACS (Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome)
Eisai
Co-PI
This was an international, multicenter, randomized Phase 2 trial of the PAR-1 receptor antagonist E5555 versus placebo in patients with acute coronary syndromes. The goal was to examine the safety and efficacy.

2009 – 2010

REACH Registry (Reduction of Atherothrombosis for Continued Health)
Bristol-Myers Squibb, Sanofi Aventis
Co-PI
This was a large, international registry of outpatients with coronary artery disease, peripheral arterial disease, and cerebrovascular disease, or patients with multiple cardiovascular risk factors. The purpose is to determine treatment patterns and outcomes in a geographically diverse cohort.

2009 – 2011

Consultant/REVEAL (Risk Evaluation and Education for Alzheimer’s Disease)
This was an NIH-funded study of the impact of genetic screening for Alzheimer’s disease on patients and their families. Additionally, the impact of incidental knowledge of cardiovascular risk was also examined.

2011 – 2016

SYMPLICITY 3
Medtronic
Co-PI
This is the pivotal US trial of catheter-based renal denervation therapy for resistant hypertension. The purpose is to determine if renal denervation is more effective than control in treating this difficult patient cohort with an acceptable safety profile.