INVESTIGATORS/
SITE COORDINATOR

STATUS

Title: IMProved Reduction of Outcomes: Vytorin Efficacy International Trial.
        ( IMPROVE- IT)

Synopsis:   Schering-Plough Research Institute on behalf of MSP Singapore Company, LLC is sponsoring a Phase 4 multicenter, double-blind, randomized study to establish the clinical benefit and safety of Vytorin (ezetimibe/simvastatin) verses simvastatin monotherapy in high-risk patients presenting with ACS.
ARMC will be one of 600 sites participating in this study projected to enroll 10,000 patients and lasting 48-60 months.
The study is designed to answer the question: Does lowering the LDL <70 mg/dl provide additional benefits to high risk ACS patients? The patient population will be high risk ACS patients presenting with clinically stable NSTEMI and STEMI and eligible to receive statin therapy. Treatment drugs will be ezetimibe/simvastatin 10/40mg or simvastatin 40mg.

Principal Investigator:
Howard Levite, MD

Co-Investigators:

• Giuseppe Gioia, MD
• Kenneth Khaw, MD
• Tome Nacimento, MD

Research Coordinator:
Jackie White, RN CRC

Initiated screening in 2007- ongoing

Title: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome.   (TRACER)

Synopsis:  Schering-Plough Research Institute is sponsoring this Phase 3 multicenter prospective, double-blind, placebo-controlled randomized trial. SCH 530348 is an investigational compound which inhibits the most potent stimulus of platelet activation, thrombin, which is a driver of the clotting process. ARMC will be one of 800 international centers participating in this study projected to enroll 10,000 patients in 30 countries. This study will evaluate the safety and efficacy of SCH 530348 in addition to standard of care in subjects with Acute Coronary Syndrome (ACS).

Principal Investigator:
Howard Levite, MD

Co- Investigator:

• Giuseppe Gioia, MD
• Kenneth Khaw, MD

Research Coordinator:
Jackie White, RN CRC

Initiated in 2008 - ongoing

Title Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The CollectIon Of Clinical Evidence
(“CHOICE”)
Design: A prospective, non-randomized, multi-center, descriptive, post-market study of two carotid artery stent systems and two embolic protection systems.

Objectives:
To provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under commercial use conditions.

To provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.
 

Principal Investigator:
Giuseppe Gioia, MD

Co-Investigators:

• Randy Mintz, MD
• Manoj Khandelwal ,MD

Research Coordinator:
Jackie White, RN CRC

Initiated in 2006-
Ongoing

Title: Stenting and Angioplasty with protection in patients at High-risk for Endarterectomy (SAPPHIRE WW)

Design: Multicenter, prospective, post-approval registry to evaluate CAS using the Cordis PRECISE® Nitinol Stent and ANGIOGUARD® XP/RX Emboli Capture Guidewire System.

Purpose Statement: The objective of the SAPPHIRE Worldwide registry is to evaluate outcomes after CAS performed by physicians with varied experience at multiple centers and utilizing a formal training program

Principal Investigator:
Giuseppe Gioia, MD

Co-Investigators:

• Randy Mintz, MD
• Manoj Khandelwal ,MD

Research Coordinator:
Jackie White, RN CRC

Initiated in 2007-
 ongoing

Title:  Patent Foramen ovale closure with the Amplatzer PFO Occluder in patients with recurrent cryptogenic stroke due to presumed paradoxical embolism through a patent foramen ovale who have failed conventional drug therapy. (ACCESS Study)

Synopsis:
The purpose of this Registry Study is to allow access to the AMPLATZER PFO Occluder in subjects with a PFO who have already experienced at least two  strokes due to presumed embolism (blood clot blocking a brain artery) passing through a patent foramen ovale and who have failed conventional drug therapy. Approximately 6000 subjects will be enrolled in this registry.

Principal Investigator: Manoj Khandelwal,  MD

Co- Investigator: 

• Giuseppe Gioia, MD

Research Coordinator: 
Jackie White RN

IRB approval Nov 2009- ongoing

Title: A Prospective, Randomized, Multi-Center, Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention with the CYPHER® Sirolimus-eluting Coronary Stent (CYPHER® Stent)
(CYPRESS Study)
Synopsis:
This is a post marketing study for patients receiving an already approved Cypher stent.  These patients will be asked to consent for an initial phase I followup which will assess the rate of target lesion failure for a 12 month duration while taking open prescription for dual antiplatlet thereapy (DAPT).   If after 12 months the patients has had no events then they will be randomized into phase II, a 18 month follow up to assess safety of patients comparing active antiplatelet therapy (DAPT) vs placebo

Principal Investigator:
Kenneth Khaw, MD

Co- Investigator:

• Howard Levite, MD

Research Coordinator: 
Jackie White RN

Initiated January 2010- ongoing

Title: “A Randomized Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients”: REducing Deaths due to OXidative Stress.
 (REDOXS Study). 
Synopsis:

The purpose of this study is to find out if giving glutamine and antioxidant supplements to critically ill patients will improve their chances of survival.  Glutamine is one of the building blocks for proteins and it plays an important role in how the body’s cells work.  Antioxidants, in the form of trace elements (minerals present in small amounts) and vitamins are naturally occurring substances that the human body needs to overcome serious illness.  During a critical illness, the levels of glutamine, antioxidants and vitamins are very low in the body which causes the immune system (helps fight infections) to not work as well.  By replacing the glutamine, antioxidants and vitamins, we may help the body deal with the stress of the critical illness.

There will be about 1200 subjects enrolled in this study in the United States, Europe and Canada and we plan to enroll about 40 subjects at AtlantiCare Regional Medical Center
                                                  

Principal Investigator:
Catherine Dudick, MD

Research Coordinator:
Jackie White RN

Projected initiation February 2010

Title:  A Clinical Outcomes Study of Darapladib versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) 
Short title:
 Stabilization of plaques using darpladib-thrombolisis in Myocardial infarction TIMI 52  (SOLID Study)

Synopsis:
The primary objective of this study is to evaluate clinical efficacy of long-term treatment with Darapladib Enteric Coated Tablets, 160 mg (oral once daily dose) as compared to placebo when added to standard of care in an ACS patient population on the incidence of first occurrence of the composite of MACE
                                                  

Principal Investigator: 
Howard Levite, MD

Research Coordinator: 
Jackie White RN

Projected initiation March 2010