Robert W. Smith, Jr., M.D., F.A.C.C. - Professional Research

Principal Investigator

• ICE-IT – A randomized, controlled study of the use of central venous catheter core cooling and rewarming as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction

Sub-investigator

• VALIANT (Valsartan in Acute Myocardial Infarction) – A Phase III, Multi-national, Multi-center, Double-blind, Randomized, Active controlled, Parallel Group Study Comparing the Efficacy and Safety of Long-term Treatment with Valsartan, Captopril, and Their Combination in High-risk Patients After Myocardial Infarction
• VALIANT REGISTRY SUBSTUDY
• EPHESUS – A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Eplerenone in Patients with Heart Failure Following Acute Myocardial Infarction
• GUSTO IV AMI – A Phase III, Randomized, Open-label Trial Evaluating the Efficacy and Safety of ReoPro â (Abciximab) in Combination with Reduced Dose Retavase â /Rapilysin Ô (Recombinant Plasminogen Activator, Retaplase, r-PA) for the Treatment of Acute Myocardial Infarction
• AMISTAD II – A Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of Adenosine (Pallacor â , Adenosine Injection) as an Adjunct to Reperfusion Therapy (Thrombolysis or Mechanical Reperfusion) in the Treatment of Acute Anterolateral Myocardial Infarction
• OCTAVE (Omapatrilat Cardiovascular Treatment Assessment Versus Enalapril) – A Phase III, Randomized, Double-blind, Active Controlled Comparison of Omapatrilat and Enalapril in Subjects with Newly Diagnosed or Established Hypertension
• REPLACE (Part 1 & 2) Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events
• CRISP – A Single Arm, Open-label Study of Cerivastatin (Baycol â ) in Community Based Patients with Hypercholesterolemia at Risk for Cardiovascular Disease
• ER TIMI 19 – A Phase IV, Open-label Trial of Prehospital Administration of Retavase â for ST Elevation MI
• Amiodarone Aqueous I.V. Injection – A Double-blind Comparison of the Incidence of Hypotension with Two Formulations of Intravenous Amiodarone: Cordarone â I.V. versus Amiodarone Aqueous I.V. Injection
• SELECT - A Multi-center, Prospective, Randomized Double-blinded, Parallel Group Study Comparing the Effects of Lotrel ® (5/20mg) to Amlodipine (5mg) and Benzaepril (20mg) on Systolic Blood Pressure and Pulse Pressure in Patients with Systolic Hypertension
• VICC - Visipaque (Iodixanol) vs. Isovue (lopamidol) in Cardiac Catheterization
• NOET - A Phase III, Open-label, Single-crossover Study to Confirm the Diagnostic Potential of Intravenously Administered 99m TcN-NOET to Identify Coronary Artery Disease During Exercise and Resting Conditions by Using Gated Myocardial SPECT Imaging
• REVERT (Reversal of Ventricular Remodeling with Toprol-XL®) - A Multi-center, Double-blind, Placebo-controlled, Randomized Trial to Evaluate the Effect of Extended Release Metoprolol Succinate (Toprol-XL®) on Cardiac Remodeling in Asymptomaatic Heart Failure Patients (NYHA Class I) with Left Ventricular Dysfunction
• MERCURY II - An Open-label Randomized, Multi-center Phase IIIb, Parallel Group Switching Study to Compare Atorvastatin and Simvastatin with Rosuvastatin in High Risk Patients with Type IIa and IIb Hypercholesterolemia
• ExTRACT-TIMI-25 – A randomized, double-blind, double-dummy, parallel group, multinational, clinical study to evaluate the efficacy and safety of Enoxaparin versus unfractionated heparin in patients with acute ST-segment elevation myocardial infarction receiving fibrinolytic therapy
• SYNERGY – A prospective, randomized, open label, multicenter study in patients presenting with acute coronary syndrome, protocol number SNO.GMA.301
• ETC-588 - A phase II, randomized, double-blind, placebo-controlled multiple-center pilot study of ETC-588 in patients with acute coronary syndromes (ACS)
• CRESTOR - A 48-Week open-label, non-comparative, multicentre, phase IIIb study to evaluate the efficacy and safety of the lipid-regulating agent Rosuvastatin in the treatment of subjects with Fredrickson Type IIa and Type IIb Dyslipidaemia, including Heterozygous Familial Hypercholesterolaemia (Protocol # 45221L/0091)
• MCC-135 – A phase II, double-blind, randomized, exploratory, placebo-controlled study of the efficacy, safety and tolerability of MCC-135 comparing QD vs BID doses in subjects with congestive heart failure, NYHA Class II/III
• ENLIGHTEN II – A non-randomized evaluation of the 3.5mm and 4.0mm multi-link vision Rx coronary stent system in the treatment of patients with De Novo native coronary artery lesions
• JUMBO (TIMI 26) – A double-blind, randomized, Multicenter, dose-ranging trial of CS-747 compared with Clopidogrel in subjects undergoing percutaneous coronary intervention
• PROTECT (TIMI 30) – A randomized trial to evaluate the relative protection against post-PCI microvascular dysfunction and post-PCI ischemia among anti-platelet and anti-thrombotic agents
• VERITAS 1 – Multicenter, double-blind, randomized, placebo-controlled parallel-group to assess the efficacy, safety and tolerability of Tezosentan in patients with acute heart failure
• MICHAELANGELO: OASIS-5 – An international randomized, double-blind, study evaluating the efficacy and safety of Fondaparinux versus Enoxaparin in the acute treatment of unstable angina / Non ST-segment elevation MI acute coronary syndromes
• TROPIC – The dose response of Niacin ER/Lovastatin on peak walking time (PWT) in patients with intermittent claudication – a Matrix Design
• ARRIVE – Taxus peri-approval registry: A two phased, multi-center safety surveillance program
• TENACITY – A randomized, Multicenter, double-blind, Abciximab-controlled study to evaluate the efficacy of Tirofiban versus Abciximab among subjects undergoing percutaneous coronary intervention with stent placement receiving Bivalirudin or Heparin. Protocol #0120-0401
• ENDEAVOR IV – A randomized, controlled trial of the Medtronic Endeavor drug (ABT-578) eluting coronary stent system versus the Taxus paclitaxel- eluting coronary stent system in De Novo native coronary artery lesions
• EARLY ACS – Early Glycoprotein IIb/IIIa inhibition in non-ST-segment elevation acute coronary syndrome: A randomized, placebo-controlled trial evaluating the clinical benefits of early front-loaded Eptifibatide in the treatment of patients with non-ST-segment elevation acute coronary syndrome
• TIMI 38 – A comparison of (CS-747) and Clopidogrel in acute coronary syndrome subjects who are to undergo percutaneous coronary intervention
• IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) A Multicenter, double-blind, randomized study to establish the clinical benefit and safety of Vytorin (ezetimibe/simvastatin tablet) vs. simvastatin monotherapy in high-risk subjects presenting with acute coronary syndrome (ACS)