Principal Investigator for the following Trial:



New York Methodist Cardiology Clinical Studies

Active Studies

TOPCAT

Project Start Day: 28 Feb 2007

Status: Active.

Principle Investigator: Dr. John Heitner

NYM# 78354

“Treatment Of Preserved Cardiac function heart failure with an Aldosterone anTagonist.”

SOLSTICE

Project Start Day: 25 Aug 2009

Status: Active.

Principle Investigator: Dr. John Heitner

NYM# 126194

“A randomized, double-blind, placebo-controlled study to evaluate the safety of 12 weeks of dosing with GW856553 and its effects on inflammatory markers, infarct size, and cardiac function in subjects with myocardial infarction without ST segment elevation Short title: SOLSTICE, A Study Of LoSmapimod Treatment on Inflammation and InfarCt SizE”

DETERMINE

Project Start Day: 23 Jul 2009

Status: Active.

Principle Investigator: Dr. John Heitner

NYM# 122659

“Defibrillators to Reduce Risk by Magnetic Resonance Imaging Evaluation (DETERMINE)”

ALECARDIO

Project Start Day: 10 Mar 2010

Status: Active

Principle Investigator: Dr. Sorin Brener.

NYM# 158014

“Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D)”

TRILOGY-ACS

Project Start Day: 27 Apr 2010

Status: Active

Principle Investigator: Dr. Sorin Brener.

WIRB-Approved

“A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) Who are Medically Managed – The TRILOGY ACS Study”

TTR

Project Start Day: 20 May 2010

Status: Active

Principle Investigator: Dr. John Heitner.

NYM# 169405

“Title Retrospective Study to Assess the Quality of Anticoagulation with Warfarin in Patients with Nonvalvular Atrial Fibrillation”

TAO

Project Start Day: 15 Jul 2010

Status: Active

Principle Investigator: Dr. John Heitner.

NYM# 171960

“A randomized, double-blind, triple-dummy trial to compare the efficacy of otamixaban with Unfractionated Heparin + eptifibatide, in patients with Unstable angina/Non ST segment Elevation Myocardial infarction scheduled to undergo an early invasive strategy (TAO)”

PROMISE

Project Start Day: 01 Jun 2010

Status: Active

Principle Investigator: Dr. John Heitner.

NYM# 171270

“Prospective Multi-center Imaging Study for Evaluation of Chest Pain (PROMISE)”

RESOLUTE-US

Project Start Day: 28 Jan 2008

Status: Active

Principle Investigator: Dr. Sorin Brener.

NYM# 100901

“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”.

DESERT

Project Start Day: 16 Jul 2009

Status: Active

Principle Investigator: Dr. Sorin Brener.

NYM# 126049

“DESERT (Drug Eluting Stent Event Registry of Thrombosis) The National DES Thrombosis Registry”

Completed Studies

PLATO

Project Start Day: 22 Mar 2005

Status: closed

Principle Investigator: Dr. Terrence Sacchi

NYM# 78439

“A Randomized, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of AZD6140 Compared with Clopidogrel for Prevention of Vascular Events in Patients with Non-ST or ST Elevation Acute Coronary Syndromes (ACS).”

ENDEAVOR IV

Project Start Day: 6 Sep 2005

Status: Closed for enrollment

Principle Investigator: Dr. Terrence Sacchi

NYM# 78437

“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 The Endeavor IV Trial”

TIMI 43- AVANTGARDE

Project Start Day: 28 Feb 2007

Status: Closed

Principle Investigator: Dr. Terrence Sacchi

NYM# 78434

“A randomized, double-blind, parallel-group, placebo-controlled,multinational clinical trial to evaluate the efficacy of Aliskiren and Valsartan versus placebo in lower levels on NT-proBNP in stabilized patients post acute coronary syndrome”

THE VOLCANO REGISTRY TRIAL:

Project start day: 15 Feb 2005

Status: closed.

Principle Investigator: Dr. Terrence Sacchi

NYM# 264

JUPITER

Project Start Day: 22 Mar 2005

Status: closed

Principle Investigator: Dr. Terrence Sacchi

NYM# 292

“A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of Rosuvastatin (CRESTOR®) 20 mg in the Primary Prevention of Cardiovascular Events Among Subjects with Low Levels of LDL-Cholesterol and Elevated Levels of C-Reactive Protein”

EARLY-ACS

Project Start Day: 24 Mar 2005

Status: closed

Principle Investigator: Dr. Terrence Sacchi

NYM# 78436

“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 (EARLY ACS)”

(MERLIN) – TIMI 36

Project Start Day: 30 Nov 2004

Status: closed.

Principle Investigator: Dr. Terrence Sacchi

NYM# 257

“Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST elevation

Acute Coronary Syndromes”

(TRITON)- TIMI 38

Project Start Day: 26 Jan 2005

Status: closed

Principle Investigator: Dr. Terrence Sacchi

NYM# 78438

“A comparison of CS-747 and Clopidogrel in ACS Syndrome subjects who are to undergo Percutaneous Coronary Intervention”

RISE TRIAL

Project start day: 25 Jan 2006

Status: closed.

Principle Investigator: Dr. Terrence Sacchi

NYM# 336

“RISE Trial A Clinical Evaluation of the StarClose™ Vascular Closure System

A Prospective, Multi-Center, Registry to Evaluate Safety and Efficacy of the Starclose™ Vascular Closure System in Patients Who Are Ambulated Early Post Diagnostic Catheterization”.

AMEthyst

Project start day: 22 Mar 2005

Status: closed.

Principle Investigator: Dr. Terrence Sacchi

NYM# 78435

“The Assessment of the Medtronic AVE Interceptor Saphenous Vein Graft Filter

REVEAL

Project Start Day: 28 Jun 2006

Status: Closed

Principle Investigator: Dr. John Heitner

NYM# 78358

“Randomized, Multi-Center, Double-blind, Placebo Controlled Trial of the Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions”.

ROCKET-AF

Project Start Day: 25 Apr 2007

Status: Closed for enrollment.

Principle Investigator: Dr. John Heitner

NYM# 78357

“ROCKET: A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dos Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects with Non-Valvular Atrial Fibrillation”

CORDIS ELITE

Project Start Day: 28 May 2008

Status: Closed for enrollment

Principle Investigator: Dr. Sorin Brener.

NYM# 87636

“A Prospective, Single Blind, Randomized, Multi-Center, Study Comparing The CYPHER® ELITE™ to The CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems”

TRACER

Project Start Day: 28 Jul 2008

Status: closed for enrollment

Principle Investigator: Dr. Sorin Brener.

Approved By WIRB

“A Multicenter, 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.”

PROTECT-(MEDTRONIC)

Project Start Day: 28 Jul 2008

Status: Closed for enrollment

Principle Investigator: Dr. Sorin Brener.

Approved By WIRB

“Patient Related Outcomes with Endeavor versus Cypher stenting Trial”

PROTECT-CA (MEDTRONIC)

Project Start Day: 19 Feb 2008

Status: Closed for enrollment

Principle Investigator: Dr. Sorin Brener.

Approved By WIRB

“Patient Related OuTcomes with Endeavor versus Cypher stenting Trial –

PROTECT Continued Access Post Marketing Surveillance Trial”

INNOVATE-PCI

Project Start Day: 24 Sep 2008

Status: closed

Principle Investigator: Dr. Sorin Brener.

NYM# 95477

A Randomized, Double-Blind, Active-Controlled Trial to Evaluate

“Intravenous and Oral PRT060128, a Selective and Reversible P2Y12-Receptor Inhibitor, vs. Clopidogrel, as a Novel Antiplatelet Therapy in Patients Undergoing Non-Urgent Percutaneous Coronary Intervention (INNOVATE-PCI)”

MIP-BP23, (ZEUS)

Project Start Day: 6 Jul 2007

Status: Closed

Principle Investigator: Dr. Lijun Weng.

NYM# 78554

“Open-Label, Phase 2 Study of the Safety and Efficacy of ß-Methyl-p- [123I]-Iodophenyl-Pentadecanoic Acid (Iodofiltic Acid I 123) for Identification of Ischemic Myocardium Using Single Photon Emission Computed Tomography (SPECT) in Adults with Symptoms Consistent with Acute Coronary Syndrome (ACS)”

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