Thaddeus R. Tolleson, M.D., F.A.C.C. - Professional Research

Duke Clinical Research Institute

• Clinical Trials in Acute Coronary Syndromes and Percutaneous Interventions: design, implementation, and analysis of multi-center clinical trials in the setting of acute coronary syndromes and coronary interventions. Primary research focus on clinical outcomes with new antiplatelet agents and antithrombins.
  • Developed protocols for phase II (PYRAMID) and phase III (PLATINUM) clinical trials
  • Presented study findings at national scientific meetings
  • Manuscript preparation for publication in peer-reviewed journals
  • Project management including regulatory affairs, budget negotiations, site management and monitoring
  • Performed CEC adjudication/review for multiple phase III clinical trials
  • Coordinated clinical hotline for multicenter studies
  • Master’s program for health science/clinical research at Duke University

University of Texas Medical School - Houston

• Pathophysiology of acute coronary syndromes in canine models.
  Worked in the laboratory of Richard Smalling, MD, PhD. Developed canine model of acute coronary occlusion to study effects of pharmaceutical agents on infarct size and reperfusion injury. Findings published in the Journal of the American College of Cardiology

Tyler Cardiovascular Consultants, P.A.

Principal Investigator

• GAAME - Gemini Angioplasty and Aterial Management Evaluation
• CHOICE – Carotid stenting for high surgical-risk patients; Evaluating outcomes through the collection of clinical evidence
• EXACT – Emboshield and Xact Post Approval Carotid stent Trial (AbbottVascular)
• CAPTURE & CAPTURE 2 – A post-approval study of the Guidant carotid stent systems and embolic protection systems (Carotid Rx Acculink/Accunet Post-Approval trial 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
• TROPIC – The dose response of Niacin ER/Lovastatin on peak walking time (PWT) in patients with intermittent claudication – a Matrix Design
• 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

Sub-Investigator

• ASCEND-HF – Double-blind, placebo-controlled, multicenter acute study of clinical effectiveness of Nesiritide in subjects with decompensated heart failure (Protocol A 093)
• TOPCAT – Treatment of preserved cardiac function heart failure with an Aldosterone antagonist (IND #71,883)
• 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.
• 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)
• 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)
• IMPROVE-IT – A Multicenter, double-blind, randomized study to establish the clinical benefit and safety of Vytorin (Ezetimibe/Simvasgtatin Tablet) vs. Simvastatin monotherapy in high-risk subjects presenting with acute coronary syndrome (Improved Reduction of Outcomes: Vytorin Efficacy International Trial – IMPROVE IT)
• TIMI 38 – A comparison of (CS-747) and Clopidogrel in acute coronary syndrome subjects who are to undergo percutaneous coronary intervention
• JUMBO (TIMI 26) – A double-blind, randomized, multicenter, dose-ranging trial of CS-747 compared with clopidogrel in subjects undergoing percutaneous coronary intervention
• FLAME – The (Boston Scientific) FilterWire EZ system used in the treatment of an acute myocardial infarction for embolic protection protocol
• 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
• ARRIVE – Taxus peri-approval registry: A two phased, multi-center safety surveillance program
• 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
• 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)
• 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
• 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