Frank I. Navetta, M.D., F.A.C.C., F.S.C.A.I. - Professional Research

• EPIC - A Phase III Study of Chimeric 7E3 Fab in Patients Undergoing High-risk Angioplasty (#1 in enrollment)
• Integrelin versus Aspirin in Unstable Angina - A Randomized, Double-blind, Comparative Safety and Efficacy Evaluation (Phase II) of Integrelin versus Aspirin in the Management of Unstable Angina
• IMPACT I - A Randomized, Double-blind Trial of Integrelin versus Placebo in the Setting of Coronary Angioplasty
• IMPACT II - A Randomized, Double-blind Efficacy and Safety Evaluation of Two Dosing Regimens of Integrelin versus Placebo for Reducing the Complication of Coronary Angioplasty
• The Use of Palmaz Biliary Stents in Large (>4.0mm Diameter) Saphenous Vein Grafts
• UTOPIA - Adjunctive Tissue Plasminogen Activator and Heparin During Angioplasty in Unstable Angina
• EPILOG - A Phase III, Randomized, Double-blind, Placebo-controlled Trial Evaluating 30 Day and 6 Month Clinical Outcome Following Percutaneous Coronary Intervention in Patients Treated with c7E3 Fab Bolus Plus 12 Hour Infusion Given with Either Standard-dose Weight-adjusted or Low-dose Weight-adjusted Heparin (Top 10 in enrollment)
• GUSTO III (Global Use of Strategies To Open Occluded Coronary Arteries) - A Randomized Trial of Reteplase (r-PA) versus Accelerated Alteplase (t-PA) for the Treatment of Acute Myocardial Infarction
• PURSUIT - A Randomized, Double-blind Evaluation of the Efficacy and Safety of Two Dosing Regimens of Integrelin versus Placebo for Reducing Mortality and Myocardial Re-infarction in Patients with Unstable Angina or Non Q-Wave Myocardial Infarction
• The Use of Phentermine and Fenfluramine in Obese Patients with Established Cardiovascular Disease
• TIMI 14 - A Phase II Randomized, Open-label, Angiographic Trial Evaluating the Benefit of ReoPro Bolus Plus 12 Hour Infusion Alone or in Conjunction with Thrombolytic Therapy for Acute Myocardial Infarction
• 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
• 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)
• ATLAST - Antiplatelet Therapy versus Lovenox Plus Antiplatelet Therapy for Patients with an Increased Risk of Stent Thrombosis
• 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 (#1 in enrollment)
• HALT MI – A Phase 2 Safety and Efficacy Study of Hu23F2G on Patients with Acute Myocardial Infarction with Direct Angioplasty
• INTRO AMI – A Pilot Phase II Safety and Efficacy Evaluation of Eptifibatide (Integrelin) in Patients Receiving Low Dose and Standard Dose Thrombolytic Therapy (Alteplase) for Acute Myocardial Infarction (AMI)
• GUSTO IV ACS – A Phase III, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of ReoPro â , Given as a Bolus Followed by a 24 or 48 Hour Infusion for the Treatment of Acute Coronary Syndrome Without ST Segment Elevation
• APLAUD – A 12 week, Double-blind, Parallel-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect of Platelet Aggregation of a Dose Range of SB 214857 When Added to Aspirin in Patients with Myocardial Infarction, Unstable Angina, Transient Ischemic Attack, or Stroke
• 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
• 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 Reperfusion) in the Treatment of Acute Anterolateral Myocardial Infarction
• WIZARD – A Randomized, Double-blind, Placebo-controlled Trial of the Effects of Weekly Azithromycin on the Incidence of Coronary Artery Disease in Subjects with Evidence of Exposure to C. Pneumoniae
• POSTIT – Boston Scientific Scimed, Inc.-Post Market Research Study on the NIR Stent and Other Commercially Available Coronary Stents
• 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
• RAFT – A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Slow Release Propafenone (Rythmol®-SR) in the Prevention of Symptomatic Recurrences of Atrial Fibrillation
• 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
• 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 and Preserved Left Ventricular Function (0007)
• HERMES – A prospective, non-randomized, multi-center, single-arm clinical trial to assess the safety and efficacy of the Rx Herculink 14 peripheral stent system for treatment of sub-optimal post-procedural percutaneous transkluminal angioplasty (PTA) results in DE NOVO or restenotic renal artery stenoses
• OCTAVE - Omapatrilat Cardiovascular Treatment Assessment Versus Enalapril
• 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
• VICC - Visipaque (Iodixanol) vs. Isovue (Iopamidol) in cardiac catheterization
• ENLIGHTEN II – A non-randomized evaluation of the 3.5 mm and 4.0 mm multi-link vision Rx coronary stent system in the treatment of patients with De Novo native coronary artery lesions

Sub-Investigator

• Phase I Study of a Monoclonal Antibody 7E3 F(ab’)2 Against the Platelet Glycoprotein IIb/IIIa Receptor in Patients Undergoing Elective PTCA
• DUCCS 1 (Duke University Clinical Cardiology Study) - A Randomized Trial of Heparin in Conjunction with Anistreplase in Acute Myocardial Infarction
• DUCCS 2 (Duke University Clinical Cardiology Study 2) - A Randomized Trial of Anistreplase without Heparin versus tPA with Heparin in Acute Myocardial Infarction
• LATE (Late Assessment of Thrombolytic Efficacy) - An Anglo-Scandinavian North American Multi-center Trial of Alteplase Therapy in Patients who Present with Acute Myocardial Infarction Greater Than 12 Hours Following Onset of Symptoms
• TIMI 3 (Thrombolysis in Myocardial Ischemia and Unstable Angina) - The Comprehensive Management of Unstable Angina and Non Q-wave Infarction in a Randomized, Double-blind Fashion with tPA or Placebo
• Cardizem CD - The Safety and Efficacy of Cardizem-CD for the Treatment of Stable Angina Pectoris
• HIRULOG - A Comparative Study for the Safety and Efficacy of B68967 with Heparin in Patients with Unstable Angina Undergoing PTCA
• PRAISE (Prospective Randomized Amlodipine Survival Evaluation) - A Randomized, Double-blind, Dose-titration, Parallel Group, Placebo-controlled Study to Evaluate the Effect of Amlodipine on Mortality and Morbidity in Patients with Severe Heart Failure
• CAVEAT 2 - Coronary Angioplasty versus Excisional Atherectomy Trial in Saphenous Vein Grafts
• FIRST - A Multi-national, Open-label, Randomized, Parallel Group Comparison of the Effects of Chronic Flolan Therapy Plus Conventional Therapy to Conventional Therapy Alone on Survival in Patients with Severe Refractory Congestive Heart Failure
• CARS (Coumadin Aspirin Re-infarction Study) - A Randomized, Double-blind Study to Compare the Efficacy and Safety of Fixed Low Doses of Coumadin Plus Aspirin to Aspirin Alone in the Prevention of Reinfarction, Cardiovascular Death, and Stroke in Post-myocardial Infarction Patients
• TIMI 9 (Thrombolysis and Thrombin Inhibition in Acute Myocardial Infarction) - Hirudin in Acute Myocardial Infarction
• ANGLE - Angioplasty of Bend Lesions
• LEXUS with Gas (Losartan with Exercise in the United States with Gas Exchange Analysis) - A Multi-center, Double-Blind, Randomized, Parallel, Placebo-controlled Study to Investigate the Effects of Losartan on the Exercise Capacity and Clinical Status of Patients with Symptomatic Heart Failure
• TIMI 10A – A Phase I Dose-escalation, Single Administration Study to Determine the Pharmacokinetics, Safety and Tolerance of TNK-tPA in Acute Myocardial Infarction.
• TIMI 10B - A Phase II Randomized, Open-label, Multi-center, International Trial of the Patency of TNK-tPA Compared with Accelerated Activase Alteplase rt-PA in Acute Myocardial Infarction
• PRAISE 2 (Prospective Randomized, Amlodipine Survival Evaluation 2) - A Randomized, Double-blind, Dose-titration, Parallel Group, Placebo-controlled Study to Evaluate the Effect of Amlodipine on Survival in Patients with Congestive Heart Failure
• Dofetilide 128 - A Randomized, Double-blind, Placebo-controlled Evaluation of Orally Administered Dofetilide in Subjects with Symptomatic Paroxysmal Atrial Fibrillation or Flutter
• Dofetilide 128A Extension – A Long-term Extension Double-blind Converting to Open-label
• SPICE (Study of Patients Intolerant of Converting Enzyme Inhibitors) - A Randomized, Double-blind, Placebo-controlled, Parallel Group, Fixed Titration Study Comparing Candesartan Cilexetil to Placebo in Congestive Heart Failure Patients with Perceived ACE-I Intolerance
• ELITE II – A Multi-center, Double-blind, Parallel, Captopril-controlled Study to Evaluate the Effects of Losartan on Mortality in Patients with Symptomatic Heart Failure
• GUARDIAN – A Double-blind Trial to Investigate Whether Cariporide Reduces the Combined Incidence of All-cause Mortality and Myocardial Infarction in Patients at Risk of Myocardial Necrosis Due to ACS 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 Angioplasty With or Without Intracoronary Stent Placement
• 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
• LIMIT AMI – A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center Angiographic Trial of the Safety and Efficacy of rhuMAb CD18 in Acute Myocardial Infarction
• GUSTO IV AMI – A Phase III, Randomized, Open-Label Trial Evaluating the Efficacy and Safety of ReoPro® (Abciximab) in Combination with Reduced Dose Retavase®/Rapilysin TM (Recombinant Plasminogen Activator, Reteplase, r-PA) for the Treatment of Acute Myocardial Infarction
• BRAVO – Blockade of the GP 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
• OVERTURE – Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events
• 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
• 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
• TARGET – A Randomized, Multi-center, Double-blind, Abcicimab-controlled Study to Evaluate the Efficacy of Tirofiban in Patients Undergoing Percutaneous Intervention with Intracoronary Stent Placement (Top 10 for enrollment)
• 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
• 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
• REPLACE (Part 1) – Randomized evaluation in percutaneous coronary intervention linking Angiomax to reduced clinical events (TMC-BIV-00-01) (#2 in enrollment)
• REPLACE (Part 2) – (TMC-BIV-01-03) (#1 in World for enrollment)
• ADEPT – the advanced elements of pacing trial (ADEPT) A factorial trial of automatic rate modulation and mode-switching in Kappa 400 DDDR recipients
• 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
• 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
• 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
• 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
• 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
• 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
• TIMI 26 (JUMBO) – A double-blind, randomized, Multicenter, dose-ranging trial of CS-747 (LY640315) compared with Clopidogrel in patients undergoing percutaneous coronary intervention
• 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
• 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
• 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
• CAPTURE & CAPTURE 2 – A post-approval study of the Guidant carotid stent systems and embolic protection systems (Carotid Rx Acculink/Accunet Post-Approval trail to uncover unanticipated or rare events)
• 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 subjects who are to undergo percutaneous coronary intervention
• ARRIVE – Taxus peri-approval registry: A two phased, multi-center safety surveillance program
• 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 (IDE #G030249)
• 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)
• EXACT Study – Emboshield and Xact Post Approval Carotid Stent Trial using the Emboshield® BareWire™ Rapid Exchange Embolic Protection System and Xact® Rapid Exchange Carotid Stent System (Abbott Vascular Devices)
• CHOICE – Carotid stenting for high surgical-risk patients; Evaluating outcomes through the collection of clinical evidence (“CHOICE”)
• 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 acute coronary syndrome (protocol CV185023)
• RE-LY STUDY – Randomized evaluation of long term anticoagulant therapy comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi0centre, parallel-group, non-inferiority trial.