David A. Hector, II, M.D., F.A.C.P., F.A.C.C., F.S.C.A.I., F.A.A.C. - Professional Research

Principal Investigator

• GUARDIAN - Hoechst Marion Roussel, Inc. – A Phase II Clinical Trial to Determine the Safety and Tolerability of Multiple Doses of HOE642A/2007 Given Intravenous to Patients with Unstable Angina Pectoris
• GUARDIAN – A Double-blind, Placebo-controlled, Multi-national Trial to Investigate the Effect of the Na+/H+ Exchange Inhibitor HOE642 (Cariporide) on All-cause Mortality and Myocardial Infarction in Patients at Risk of Myocardial Necrosis Due to Acute Coronary Syndrome Related to the Disease Process or to an Interventional Cardiac Procedure
• ASTRA – A Double-blind, Placebo-controlled, Multi-center Pilot Study to Assess the Safety and ex vivo Platelet Aggregation Response of Intravenous AR-C69931MX in Patients Undergoing Percutaneous Transluminal Coronary Angioplasty, With or Without Intracoronary Stent Placement (Part 1 Double Blind vs. Placebo).
• ASTRA (Part 2 Open-label vs. Abciximab) - A Multi-center Pilot Study to Assess the Safety and ex vivo Platelet Aggregation Response of Intravenous AR-C69931MX in Patients Undergoing Percutaneous Transluminal Coronary Angioplasty With or Without Intracoronary Stent Placement
• PTMR – Percutaneous Transluminal Myocardial Revascularization sponsored by Eclipse Surgical Technologies
• SPORTIF V – Efficacy and Safety Study of the Oral Direct Thrombin Inhibitor H 376/95 Compared with Dose-adjusted Warfarin (Coumadin®) in the Prevention of Stroke and Systemic Events in Patients with Atrial Fibrillation
• ETC-588 - A phase II, randomized, double-blind, placebo-controlled multiple-center pilot study of ETC-588 in patients with acute coronary syndromes (ACS)
• VERIFIED Pacemaker Registry – Value of Electronically Recorded and Interrogated Follow-up via IPG Exported Data
• ETC-642 – A phase II, randomized, dose-ranging, double-blind, placebo-controlled Multicenter, pharmacokinetic, pharmacodynamic and tolerability study of ETC-642 in patients with stable atherosclerosis 6142-006 (A0091005) IND NO. 62,682

Sub-Investigator

• VA/NHLBI – A Trial to Evaluate the Effect of Digitalis on Mortality in Heart Failure
• SPEED (Strategies for Patency Enhancement in the Emergency Department) - A Phase II, Randomized, Open-label, Angiographic Trial Evaluating the Benefit of ReoPro Bolus Plus 12 Hour Infusion With and Without Thrombolytic Therapy for Acute Myocardial Infarction
• PARAGON B – A Randomized, Double-blind, Placebo-controlled Study of Lamifiban (RO 44-9883) in Patients with Unstable Angina/Non Q-wave Myocardial Infarction
• HALTMI – A Phase 2 Safety and Efficacy Study of Hu23F2G in Patients with Acute Myocardial Infarction Treated with Direct Angioplasty
• INTRO AMI – A Pilot Phase II Safety and Efficacy Evaluation of Eptifbatide (Integrelin) in Patients Receiving Low Dose and Standard Dose Thrombolytic Therapy (Alteplase) for Acute Myocardial Infarction (AMI)
• LIMIT AMI – A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Angiographic Trial of the Safety and Efficacy of rhuMAb CD 18 in Acute Myocardial Infarction
• GUSTO IV ACS – A Phase III, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of ReoPro, Given As a Bolus Followed by a 24 to 48 Hour Infusion, for the Treatment of Acute Coronary Syndrome Without ST-Segment Elevation
• AMISTAD II - A Randomized, Double-Blind. Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Adenosine (Pallacor ®, Adenosine Injection) as an Adjunct to Reperfusion Therapy (Thrombolysis or Mechanical Referfusion) in the Treatment of Acute Anterolateral Myocardial Infarction (Mother Frances Hospital)
• GUSTO IV AMI – A Phase III, Randomized, Open-label Trial Evaluating the Efficacy and Safety of ReoPro ® (Abciximab) in Combination with Reduced Dose Retavase â /Rapilysin Ô (Recombinant Plasminogen Activator, Retaplase, r-PA) for the Treatment Acute Myocardial Infarction
• Val-HeFT – A Multi-country, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Assess the Effect of Valsartan on Morbidity and Mortality, Signs and Symptoms, and Quality of Life in Patients with Stable, Chronic, Congestive Heart Failure (NYHA Class II-IV)
• SADHART (Sertraline Antidepressant Heart Attack Randomized Trial) – A Randomized, Double-blind, Placebo-controlled Trial of Sertraline (Zoloft) for Major Depression After Acute Coronary Syndromes: Myocardial Infarction or Unstable Angina
• CAPRICORN – A Multi-national, Multi-center, Randomized, Double-blind, Parallel Group Study to Determine the Effects of Carvedilol on Mortality in Patients with Left Ventricular Dysfunction, With or Without Clinical Evidence of Heart Failure, Post Myocardial Infarction
• A to Z – A Multi-center, Randomized, Controlled , Double-blind Trial to Investigate the Clinical Efficacy and Tolerability of Early Treatment with Simvastatin 40 mg Daily for 30 Days Followed by Simvastatin 80 mg Daily Thereafter in Tirofiban-treated Acute Coronary Syndrome Patients Who Have Been Randomized to Receive Enoxaparin or Unfractionated Heparin in Conjunction with Aspirin
• BRACCO – A Clinical Evaluation to Determine the Optimal Imaging Parameters for Tc-99m Teboroxime in Subjects with Coronary Artery Disease and Subjects with No Evidence of Coronary Artery Disease
• TARGET – A Randomized, Multi-center, Double-blind, Abciximab-controlled Study to Evaluate the Efficacy of Tirofiban in Patients Undergoing Percutaneous Coronary Intervention with Intracoronary Stent Placement
• CREDO – A Double-blind, Randomized Trial of Clopidigrel 300 mg Loading Dose and Aspirin 325 mg Followed by Clopidigrel 75 mg and Aspirin Daily Compared with Placebo Loading Dose and Aspirin 325 mg Followed by Clopidigrel 75 mg and Aspirin Daily for the Prevention of Vascular Events and All-cause Mortality in Patients Undergoing Percutaneous Coronary Intervention
• GOLD – A Prospective, Multi-center, Observational Study Evaluating Platelet Function with the Accumetrics Ultegra-Rapid Platelet Function Assay (RPFA) in Patients Undergoing Coronary Interventions Using Platelet Glycoprotein IIb/IIIa Inhibitors
• POSTIT – Boston Scientific Scimed, Inc.-Post Market Research Study on the NIR Stent and Other Commercially Available Coronary Stents
• BRAVO – Blockade of the IIB/IIIA Receptor to Avoid Vascular Occlusion
• VALIANT (Valsartan in Acute Myocardial Infarction) – A 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
• CHARM (Candesartan Cilexetil in Heart Failure: Assessment of Reduction in Mortality and Morbidity) – Studies of Candesartan in Patients with Heart Failure Who Are ACE Inhibitor Intolerant and Have Depressed Left Ventricular Systolic Function (0003), Who Are Treated with ACE Inhibitors and Have Depressed Left Ventricular Systolic Function (0006), and Patients with Heart Failure Who Have Preserved Left Ventricular Function (0007)
• RAFT – A Double-blind, Placebo-controlled, Randomized Clinical Trial of Slow Release Propafenone (Rythmol â SR) in the Prevention of Symptomatic Recurrences of Atrial Fibrillation
• OVERTURE – Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events
• WIZARD – A Randomized, Double-blind, Placebo-controlled Trial of the Effect of Weekly Azithromycin on the Incidence of Coronary Artery Disease in Subjects with Evidence of Exposure to C. Pneumoniae
• SYNERGY – A prospective, randomized, open label, multicenter study in patients presenting with acute coronary syndrome, protocol number SNO.GMA.301
• COMMA – A randomized, double-blind, placebo-controlled study of two intravenous dosing regimens of h5G1.1-scFv in patients with acute myocardial infarction undergoing percutaneous transluminal coronary angioplasty reperfusion therapy
• NOET – A Phase III, Open0label, Single-crossover Study to Confirm the Diagnostic Potential of Intravenously-Administered 99mTcN-NOET to Identify coronary Artery Disease during Exercise and Resting Conditions by using Gated Myocardial SPECT Imaging
• RAPSODY – A multicenter, randomized, double-blind, placebo-controlled dose-ranging, safety and efficacy study of precombinant P-Selectin glycoprotein ligand-Ig (rPSGL-Ig) in combination with thrombolytic therapy in patients with acute myocardial infarction
• REPLACE (Part 1) – Randomized evaluation in percutaneous coronary intervention linking Angiomax to reduced clinical events (TMC-BIV-00-01)
• REPLACE (Part 2) – (TMC-BIV-01-03)
• ADEPT – the advanced elements of pacing trial (ADEPT) A factorial trial of automatic rate modulation and mode-switching in Kappa 400 DDDR recipients
• VICC – Visipaque (Iodixanol) vs. Isovue (Iopamidol) in cardiac catheterization
• CHESS (Comparative HDL Efficacy and Safety Study) – A Multi-center, Double-blind, Randomized, Parallel, 28-Week Study to Evaluate the Efficacy and Safety of Simvastatin 80 mg/day Versus Atorvastatin 80 mg/day in Patients with Hypercholesterolemia
• OCTAVE - Omapatrilat Cardiovascular Treatment Assessment Versus Enalapril
• STELLAR (Statin Therapies for Elevated Lipid Levels Compared Across Rosuvastatin) – A 6-Week, Open-label, Dose-comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Cerivastatin, Pravastatin, and Simvastatin in Subjects with Hypercholesterolemia
• 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 Asymptomatic Heart Failure Patients (NYHA Class I) with Left Ventricular Dysfunction
• SELECT – A Multi-center Prospective Randomized, Double-blinded, Parallel Group Study Comparing the Effects of Lotrel® (5/20mg) to Amlodipine (5mg) and Benazepril (20mg) on Systolic Blood Pressure and Pulse Pressure in Patients with Systolic Hypertension
• 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
• 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
• 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)
• SAVE PACe - Search AV extension for promoting atrioventricular conduction
• RESTORE US – Registry of cardiac resychronization therapy-U.S.
• 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 antithrombotic agents
• VERITAS 1 – Multicenter, double-blind, randomized, placebo-controlled parallel-group to assess the efficacy, safety and tolerability of Tezosentan in patients with acute hart 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
• 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
• 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
• 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 in subjects who are to undergo percutaneous coronary intervention
• ARRIVE – Taxus peri-approval registry: A two phased, multi-center safety surveillance program
• IMPROVE-IT – 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 (Improved Reduction of Outcomes: Vytorin Efficacy International Trial)
• CURRENT / OASIS 7 – Clopidogrel optimal loading dose usage to reduce recurrent events / optimal antiplatelet strategy for interventions
• CHAMPION Platform – A clinical trial comparing treatment with Cangrelor (in combination with usual care) to usual care, in subjects who require percutaneous coronary intervention (Protocol No. TMC-CAN-05-03)
• APPRAISE 1 – A phase 2, placebo-controlled, randomized, double-blind, parallel arm, dose ranging study to evaluate safety and efficacy of Apixaban in patients with recent coronary syndrome (protocol CV 185023)
• FUSION II – Follow-up Serial Infusions of Natrecor® (nesiritide) for the Management of Patients with Heart Failure
• TOPCAT – Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist – A Multi-center, International, Randomized, Double-blind, Placebo-controlled Trial of the Aldosterone Antagonist, Spironolactone, in Adults with Heart Failure and Left Ventricular Ejection Fraction of at Least 45%