Acute Coronary Syndrome Trials/MI Trials

CHAMPION-PCI Trial:  A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects who require percutaneous Coronary Intervention

The purpose of this study is to compare the effects of cangrelor with the standard treatment, clopidogrel, in subjects having a percutaneous coronary intervention for acute coronary syndrome.

Sponsor:  The Medicines Company
Principal Investigator:  Janet Strain, MD
Co-Investigators:  Arvind Agarwal, MD; Navin Budhwani, MD; Steven Kernis, MD; Michael Kesselbrenner, MD; Dennis Reison, MD; Alan Simon, MD; Robert Saporito, MD

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Current:  Clopidogrel optimal loading dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for Interventions.  “A Randomized, Multi-National, Double-Blind Study Comparing a High Loading Dose Regimen of Clopidogrel versus Standard Dose in Patients with Unstable Angina or Non-St Segment Elevation Myocardial Infarction Managed with an Early Invasive Strategy” Study Number EFC5965

This study is for patients that are admitted to the hospital with acute coronary syndrome.  They will be randomized to high (600mg) or low (300mg) dose plavix.  Plavix is an approved drug.  Patients will receive plavix for 1 month and come back to our clinic for a follow up.

Sponsor:  Sanofi-Aventis U.S., Inc.
Principal Investigator:  Janet Strain, MD
Co-Investigators:  Arvind Agawal, MD; Navin Budhwani, MD; Steven Kernis, MD; Michael Kesselbrenner, MD; Alan Simon, MD; Robert Saporito, MD; Joseph Wiederman, MD

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DAL-Outcomes:  A phase III, double blind, randomized placebo-controlled study, to evaluate the effects of RO4607381 on cardiovascular (CV) risk in stable CHD (Coronary Heart Disease) patients, with a documented recent Acute Coronary Syndrome (ACS)

*** We hope to learn if RO4607381 will reduce the risk of death from cardiovascular disease or having a cardiovascular event.

Sponsor:  Hoffman La-Roche, Inc.
Principal Investigator:  Michael Kesselbrenner, MD
Sub-Investigators:  Arvind Agarwal, MD; Navin Budhwani, MD; John Strobeck, MD; Janet Strain, MD; Howard Goldschmidt, MD; Marcus Williams, MD; Michael Kesselbrenner, MD; Robert Saporito, MD; Alan Simon, MD

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IMPROVE IT:  Improved Reduction of Outcomes Vytorin Efficacy International Trial

The purpose of this study is to compare two drugs, Vytorinâ and Zocorâ.  We want to see how well each of these drugs can lower LDL-C (“bad” cholesterol) levels.  Both Vytorinâ and Zocorâ are already approved by the US Food and Drug Administration for lowering cholesterol levels in the blood.

Sponsor:  Merck & Company & Shering-Plough Research Institute
Principal Investigator:  Michael Kesselbrenner, MD
Sub Investigators:  Robert Saporito, MD; Alan Simon, MD; Janet Strain, MD; Arvind Agarwal, MD; John Pantazopoulous, MD; Cary Hirsch, MD; Howard Goldschmidt, MD; Dennis Reison, MD; Navin Budhawani, MD; Marcus Williams, MD; Robert Baklajian, MD

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Intensive:  A Multi-Center Phase IIIb, Stratified, Randomized, Open-Label Clinical Trial to Evaluate the Efficacy to Intensive Apidra® Lantus® Therapy versus Sliding Scale Insulin on Infarct Size in Hyperglycemic Subjects with Anterior STEMI (ST Elevation Myocardial Infarction) undergoing PCI (Percutaneous Coronary Intervention)

The purpose of this study is to find out whether or not Apidra^® (insulin glulisine) given through an intravenous line (IV), a plastic tube in your vein, followed by Lantus^® injected subcutaneously (SQ), or directly under the skin, reduces heart attack size in Patients that have had a recent heart attack and need to have a Percutaneous Coronary Intervention.

Sponsor:  Sanofi-Aventis U.S.
Principal Investigator:  Michael Kesselbrenner, MD
Co-Investigators:  Arvind Agarwal, MD; Navin Budhwani, MD; Steven Kernis, MD; Janet Strain, MD

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RECOVER II:  A Prospective Randomized Trial Investigating the Use of IMPELLA® RECOVER® LP 2.5 System in Patients with Acute Myocardial Infarction Induced Hemodynamic Instability

The purpose of this research study is to evaluate the safety and effectiveness of the IMPELLA RECOVER LP 2.5 System compared to the standard intra aortic balloon pump technology in patients experiencing low blood pressure or hypotension as a consequence of a heart attack.

Sponsor:  ABIOMED, Inc.
Principal Investigator:  Janet Strain, MD
Sub-Investigators:  Navin Budhwani, MD; Dennis Reison, MD; Michael Kesselbrenner, MD; Arvind Agarwal, MD; Robert Saporito, MD; Elliott Lichtstein, MD; Robert Baklajian, MD

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TAK-442_202:  A Phase 2, Double blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of TAK-442 in Subjects with Acute Coronary Syndromes

The purpose of this study is to compare the safety and tolerability of TAK-442 compared with placebo in subjects who have been hospitalized following acute coronary syndrome and who are also receiving other cardiovascular therapy.

Sponsor:  Takeda Global Research & Development Center, Inc., Deerfield, Illinois United States
Principal Investigator:  Michael Kesselbrenner, MD
Sub-Investigators:  Arvind Agarwal, MD; Robert Saporito, MD; Alan Simon, MD; Navin Budhwani MD; Janet Strain, MD

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Tracer:  A Multi-center, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects with Acute Coronary Syndrome:  Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome

Patients that are admitted to the hospital with acute coronary syndrome may be randomized to a new anti-thrombin medication or placebo.  This medication may be given in addition to plavix and ASA.  Patients are followed for approximately 2 years.

Sponsor:  Schering-Plough Research Institute, a Division of Schering Corporation
Principal Investigator:  Janet Strain, MD
Co-Investigators:  Arvin Agarwal, MD; Navin Budhwani, MD; Steven Kernis, MD; Michael Kesselbrenner, MD; Dennis Reison, MD; Robert Saporito, MD; Alan Simon, MD; John Weiderman, MD

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Trilogy/Taby:  A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with unstable Angina/Non-ST-Elevation Myocardial Infarction (UN/NSTEMI) Who are Medically Managed

Patients that are admitted to the hospital with acute coronary syndrome and are being treated medically will be randomized to Prasugrel or plavix.  Patients will remain on drug for approximately 2.5 years.

Sponsor:  Eli Lilly and Company
Principal Investigator:  Michael Kesselbrenner, MD
Co-Investigators:  Navin Budhwani, MD; Steven Kernis, MD; Janet Strain, MD; John Pantazopoulos, MD; Marcus Williams, MD

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VIRGO:  Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction (AMI) Patients

This is a research study of men and women who are 55 years of age or younger, who have had heart attacks.  This study is designed to help researchers and doctors better understand the recovery period by examining certain things that can influence recovery from a heart attack. 

Sponsor:  Yale University / Yale-New Haven Hospital
Funding Agency:  National Heart Lung and Blood Institute
Principal Investigator:  Gerald Sotsky, MD

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Cardiac Cath Lab Trials

AQUARIUS - Novartis Study Number CSPP100A2366:  A 104 week, randomized, double blind, placebo-controlled, parallel group, multicenter study to evaluate the efficacy of aliskiren on the progression of atherosclerosis in patients with coronary artery disease when added to optimal background therapy

This study is to determine if the drug aliskiren (Rasilez^® or Tekturna^®) is safe and has beneficial effects when added to standard medical therapy in people who have coronary artery disease.  

Sponsor:  Novartis
Principal Investigator:  Janet Strain, MD    
Sub-Investigators:  Navin Budhwani, MD; Dennis Reison, MD; Michael Kesselbrenner, MD; Arvind Agarwal, MD

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CAPTURE 2:  A post-approval Study of the Guidant acculink stent systems and accunet embolic protection systems (Carotid RX ACCULINK/ RX ACCUNET Post-Approval Trial to Uncover Unanticipated and Rare Events)

The Study is being done to collect data regarding patients’ medical experiences and conditions following treatment with the RX ACCULINK and RX ACCUNET devices.

Sponsor:  Guidant Endovascular Solutions, Inc.
Principal Investigator:  Joshua Bernheim, MD
Co-Investigators:  Daniel Char, MD; David Cohen, MD; Steven Kernis, MD; Janet Strain, MD; Daniel Walzman, MD

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ENDEAVOR RESOLUTE:  A Clinical Evaluation of the Medtronic Endeavor^® Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries with a Reference Vessel Diameter of 2.25 mm to 4.2 mm

The purpose of this study is to evaluate if the new Endeavor Resolute stent is safe and how effective the drug-eluting stent is in reducing the re-narrowing in coronary arteries over time.

Sponsor:  Medtronic Vascular, Inc.
Principal Investigator:  Janet Strain, MD
Co-Investigators:  Arvind Agarwal, MD; Navin Budhwani, MD; Michael Kesselbrenner, MD; Dennis Reison, MD; Elliott Lichtstein, MD

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FREEDOM TRIAL: Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel disease

The purpose of this study is to compare two different methods of treatment for patients with diabetes mellitus and coronary artery disease in more than one heart vessel:  coronary artery bypass graft surgery (CABG) and drug-eluting stents.  Specifically, this study is designed to evaluate whether drug-eluting stenting is more or less effective than CABG

Sponsor:  National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH)

Principal Investigator:  Cary Hirsch, MD

Co-Investigators:  Dennis Reison, MD; Janet Strain, MD; Arvind Agarwal, MD; Michael Kesselbrenner, MD; Robert Saporito, MD; Eric Bronstein, MD; Bruce Mindich, MD; Alex Zapolanski, MD

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PROTECT II: A Prospective, multi-center randomized controlled trial of the IMPELLA® RECOVER® LP 2.5 System versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non-Emergent High Risk PCI

The objective of the study is to assess the safety and efficacy of the IMPELLA^® system compared to intra-aortic balloon pump use in subjects undergoing non-emergent high-risk percutaneous coronary intervention. 

Sponsor:  ABIOMED
Principal Investigator:  Janet Strain, MD
Sub-Investigators:  Arvind Agarwal, MD; Navin Budhwani, MD; Elliott Lichtstein, MD; Michael Kesselbrenner, MD; Dennis Reison, MD

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Saturn: A 104-week, Randomized, Double-blind, Parallel group, Multicenter, Phase IIIb Study Comparing the Effects of Treatment with Rosuvastatin 40mg or Atorvastatin 80mg on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Patients with Coronary Artery Disease:  the SATURN trial

This study is for patients scheduled to have an angiogram/IVUS with slightly elevated lipid levels.  If the patient meets very specific criteria, they will be randomized to crestor vs lipitor and followed for 2 years.  The patient will need a repeat angiogram at the 2-year follow up.

Sponsor:  AstraZeneca Pharmaceuticals LP
Principal Investigator:  Janet Strain, MD
Co-Investigators:  Arvind Agarwal, MD; Navin Budhwani, MD; Dennis Reison, MD

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Spirit SV: SPIRIT Small Vessel – A Clinical Evaluation of the ABT Everolimus Eluting Coronary Stent System

If a patient requires a small stent, they can receive the investigational Xience V Stent.  Patients will need to return in 8 months for an angiogram.

Sponsor:  Abbott Vascular
Principal Investigator:  Arvind Agarwal, MD
Co-Investigators:  Navin Budhwani, MD; Michael Kesselbrenner, MD; Dennis Reison, MD; Janet Strain, MD

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XIENCE V™:  Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study

The purpose of this Study is to evaluate the continued safety and effectiveness of the XIENCE V™ Everolimus Eluting Coronary Stent System (the XIENCE V EECSS) recently approved for use by the Food and Drug Administration (FDA) for the treatment of narrowed coronary arteries (blood vessels in the heart) in a group of real-world patients.

Sponsor:  Abbott Cardiovascular Systems, Inc.
Principal Investigator:  Arvind Agarwal, MD
Sub-Investigators:  Janet Strain, MD; Dennis Reison, MD; Navin Budhwani, MD; Steven Kernis, MD; Giovani Camponile, MD; Michael Kesselbrenner, MD; Elliott Lichtstein, MD

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Cardiac Surgery Trials

BIOCOR:  Post-Approval Study Protocol of the St. Jude Medical Biocor^™ and Biocor^™ Supra Valve

The Biocor and Biocor Supra Valves are approved by the FDA for use by your doctor, but additional information on the valve is needed.  The purpose of the study is to gather additional data about the performance of the Biocor and Biocor Supra Valve.

Sponsor:  St. Jude Medical (SJM)
Principal Investigator:  Alex Zapolanski, MD
Co-Investigators:  Jason Sperling, MD

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Cardiac Surgery Tissue Banking: XXXXX

The purpose of this research is to obtain some of the excess tissue that is left over from surgeries for future research.  We also will collect two 10ml vials of blood for use in future research.  This will enable TVH to keep and use these samples in research to learn more about cardiac, vascular, and/or other diseases.  To date, Valley has collected over 900 tissue specimens.

Sponsor:  The Valley Hospital
Principal Investigator:  Alex Zapolanski, MD

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Congestive Heart Failure Trials

Ascend HF:  Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects with Decompensated Heart Failure

This study is being done to find out if the drug that is being researched, nesiritide (tradename Natrecor® as compared to placebo, plus the usual treatment for acute decompensated heart failure helps:  Improve breathing, reduce the chance that you will be readmitted to the hospital and/or have patients live longer.

Sponsor:  Scios, Inc.
Principal Investigator:  Michael Kesselbrenner, MD
Co-Investigators:  Arvind Agarwal, MD; Howard Goldschmidt, MD; Janet Strain, MD; John Strobeck, MD; Marcus Williams, MD

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Balance:  Treatment of HyponatrEmia BAsed on LixivAptan in NYHA Class III-IV Cardiac Patient Evaluation

This study is for patients that are admitted to the hospital with acute decompensated heart failure with a decreased Sodium level.  If they meet criteria they will be randomized to a new investigational drug called lixivaptan compared to placebo.  They will be followed for 3 months.

Sponsor:  CardioKine Biopharma, LLC
Principal Investigator:  Michael Kesselbrenner
Co-Investigators:  Arvind Agarwal, MD; Robin Giordano, NP; Howard Goldschmidt, MD; John  Pantazopoulos, MD; Janet Strain, MD; John Strobeck, MD; Marcus Williams, MD

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TOPCAT: Treatment of Preserved Cardiac function heart failure with an Aldosterone anTagonist

The purpose of this study is to see if adding a drug called spironolactone to the current treatments for heart failure is able to safely improve heart failure.

Sponsor:  National Heart, Lung, and Blood Institute (NHLBI), NIH/DHHS, United States
Principal Investigator:  Michael Kesselbrenner, MD
Sub-Investigators:  Robert Saporito, MD; Alan Simon, MD; Howard Goldschmidt, MD

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Trident – 1: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Parallel-group, Study to Assess The Effects of Intravenous BG9928 on Body Weight in Subjects with Acute Decompensated Heart Failure and Renal Insufficiency

The purpose of the study is to find out if treatment helps to decrease weight by increasing urine output in patients with heart failure and renal insufficiency. 

Sponsor:  Biogen, Inc.
Principal Investigator:  Michael B. Kesselbrenner, MD
Co-Investigators:  John Strobeck, MD; Marcus Williams, MD; Howard Goldschmidt, MD; Janet Strain, MD; Robin, Giordano, NP

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Electrophysiology Trials

AF-CRT Study:  The Effect of Biventricular Pacing on the Incidence of Atrial Fibrillation

The purpose of this study is to evaluate the effect of cardiac resynchronization therapy (CRT) on the incidence of AF in ICD and pacemaker device patients upgraded to cardiac resynchronization therapy.

Sponsor:  AF Research, Boston, MA.  Supported by a grant from Boston Scientific
Principal Investigator:  Tina Sichrovsky, MD
Co-Investigators:  Aysha Arshad, MD; Suneet Mittal, MD; Mark Preminger, MD; Jonathan Steinberg, MD

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BOAT: Beta Blocker Uptitration with Optivol After CRT

The purpose of this study is to determine whether beta-blocker dosage can be increased after the subjects receive the planned biventricular pacemaker (BIVPM).  It also measures whether the increased dose of beta-blocker improves the way the heart muscle works and how the heart is shaped.

Sponsor:  The St. Luke’s - Roosevelt Hospital Center
Principal Investigator:  Marrick Kukin, MD
Co-Investigators:  Aysha Arshad, MD; Jonathan Steinberg, MD; Tina Sichrovsky, MD; Mark W. Preminger, MD

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IMPACT: The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with Implanted ICD and CRT-D devices

This study will help doctors to determine whether HM detection of abnormal atrial heart rhythms and early use of blood thinning medication in patients implanted with ICDs or CRT-Ds can reduce the chance of stroke and systemic blood clots.

Sponsor:  BIOTRONIK, Inc.
Principal Investigator:  Suneet Mittal, MD
Sub-Investigators:  Jonathan Steinberg, MD; Aysha Arshad, MD; Mark Preminger, MD; Tina Sicharsky, MD; Navin Budhwani, MD; Kenneth Levin, MD

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MADIT II:  Risk Stratification in MADIT II Type Patients

This study is to determine what clinical and ECG factors identify patients at risk for cardiac events in patients after heart attack with impaired heart function.

Sponsor:  National Institutes of Health
Principal Investigator:  Arshad Aysha, MD
Sub-Investigators:  Jonathan Steinberg, MD; Suneet Mittal, MD; Mark Preminger, MD; Tina Sichrosky, MD

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OBSERV ECG:  Observational Study of the Sleuth Implantable ECG Monitoring System

The Sleuth Implantable ECG Monitoring System has FDA clearance to be marketed in the US.  This study is being conducted to assess actual use of the system and to collect information on diagnostic outcome.  This investigation is for purposes of data gathering only.

Sponsor:  Transoma Medical
Principal Investigator:  Suneet Mittal, MD
Sub-Investigators:  Aysha Arshad, MD; Mark Preminger, MD; Tina Sichrovsky, MD; Jonathan Steinberg, MD

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WBC Trial:  Who Benefits from Cardiac Resynchronization Therapy (CRT)?

The purpose of this study is to evaluate if Tissue Doppler, cMRI and Echo testing can correctly predict which patients will respond to CRT.

Sponsor:  St Jude Medical 
Principal Investigator:  Suneet Mittal, MD
Sub-Investigators:  Jonathan Steinberg, MD; Aysha Arshad, MD; Mark Preminger, MD; John Strobeck, MD

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Outpatient Trials

GET Goal:  A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week main treatment period and an extension assessing the efficacy and safety of AVE0010 on top of pioglitazone in patients with type 2 diabetes not adequately controlled with pioglitazone

The purpose of this study is 1) to confirm that 20 microgram (µg) of AVE0010 administered once daily in the morning before breakfast, in comparison with placebo, has a beneficial effect on the blood glucose, and 2) to investigate its possible side effects in type 2 diabetic patients who are already treated but not adequately controlled with pioglitazone in association or not with metformin for at least 3 months.  This dose of AVE0010 has already been tested in three other studies in type 2 diabetic patients.

Sponsor:  Sanofi-Aventis U.S., Inc.
Principal Investigator:  Michael Kesselbrenner, MD

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MTAP:  Myozyme® Temporary Access Program

The purpose of this program is to provide patients with Pompe disease in the United States (US) access to investigational Myozyme^® produced from a scaled up manufacturing process for a limited time until production at this scale is approved for commercial use by the Food and Drug Administration (FDA).

Sponsor:  Genzyme Corporation
Principal Investigator:  Steven C. Jacoby, MD

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Pfizer A4091025:  A Phase 3, multi-center, randomized, double-blind, controlled study of the long-term analgesic efficacy and safety of Tanezumab alone or in combination with non-steroidal anti-inflammatory drugs (NSAIDs) versus NSAIDs alone in patients with osteoarthritis of the knee or hip

The purpose of this study is to determine whether or not the study drug tanezumab alone or in combination with an additional drug (celecoxib or naproxen) reduces the pain in patients with osteoarthritis of the knee or hip better than placebo in combination with celecoxib or naproxen.

Sponsor:  Pfizer
Principal Investigator:  Michael Gross, MD

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PRECISION:  A Randomized, Double Blind, Parallel-Group Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patients With or at High Risk for Cardiovascular Disease Comparing Celecoxib with Naproxen and Ibuprofen

The purpose of this study is to assess the effects of long-term use of celecoxib compared to ibuprofen and naproxen on cardiovascular, gastrointestinal, and renal safety.  Additionally, the ability of each drug to control arthritis pain effectively will be evaluated.

Sponsor:  Pfizer
Principal Investigator:  Michael Kesselbrenner, MD
Sub-Investigators:  Arvind Agarwal, MD; Navin Budhwani, MD; Edward Ewald, MD; Howard Goldschmidt, MD; Evan Leibowitz, MD; Robert Saporito, MD; Alan Simon, MD; Janet Strain, MD; Marcus Williams, MD

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RE-LY Atrial Fibrillation (AF) Registry:  Risk Factors, Treatments and Outcomes for Emergency Department Patients with Atrial Fibrillation in Multiple Regions of the World

The purpose of this study is to describe and register regional differences in patients who present to hospitals with atrial fibrillation and how their condition is managed.

Sponsor:  Boehringer Ingelheim Pharmaceuticals, Inc
Principal Investigator:  Marcus L. Williams, MD

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Warcef:  Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction

The purpose of this research study is to determine which of two commonly used treatments, warfarin [Coumadin®], or aspirin, a drug which reduces platelet function, is better for preventing death and stroke in patients with poor heart function.

Sponsor:  The National Institutes of Health – National Institute of Neurological Disorders and Stroke
Principal Investigator:  Janet Strain, MD
Sub-Investigators:  Laurie DeCourcio, NP; Robin Giordano, NP; John Strobeck, MD; John Pantazopolous, MD; Michael Kesselbrenner, MD; Howard Goldschmidt, MD; Marcus Williams, MD