Research and Clinical Trials

Heart & Vascular Research and Clinical Trials at St. Luke's

Heart and Vascular Clinical Trials at St. Luke's
St. Luke's Heart & Vascular Center
1469 Eighth Avenue, Suite 202
Bethlehem, PA 18018
484-526-2450
Maps & Directions

Saving Lives Through Cardiac and Vascular Research

Our patients gain access to promising new treatments and technologies before they are available to the general population.

Our experienced team of physicians, researchers and research nurses work closely to incorporate research findings into the comprehensive care of our heart and vascular patients.

The goal throughout is to improve patient outcomes and save more lives in the process.

Cardiac Trials

Acute Coronary Syndrome Trials

IMPROVE-IT

Purpose: to establish the benefit and safety of Vytorin versus simvastatin monotherapy in high risk patients hospitalized with acute coronary syndrome. (Note: closed to enrollment)

Principal Investigator - Dr. H. T. Dale

Sub Investigators

TRA- 2p TIMI 50

Purpose: to evaluate the safety and efficacy of the study medication in addition to standard of care in subjects with a history of atherosclerotic disease. (Note: closed to enrollment)

Principal Investigator - Dr. P. Puleo

Sub Investigators

TABY

Purpose: to compare Prasugrel versus Clopidogrel (Plavix) in patients hospitalized for acute coronary syndrome (ACS) who are medically managed.

Principal Investigator - Dr. L. Tejada
Sub Investigator - Dr. J. Gallagher

TIMI- 52

Purpose: to evaluate the safety and efficacy of the study medication versus placebo in addition to the standard of care in subjects hospitalized with an acute coronary syndrome (ACS). The study medication decreases the inflammatory response which contributes to atherosclerotic disease.

Principal Investigator - Dr. P. Puleo

Sub Investigators


Pulmonary Trials

LOTT

Purpose: This study is investigating the effects of oxygen therapy in two types of patients with Chronic Obstructive Pulmonary Disease (COPD). We already know that 24-hour oxygen therapy improves and prolongs the lives of people with COPD who have a very low level of oxygen in their blood at rest, but we do not know if oxygen therapy helps two other types of people with COPD: COPD patients who have a moderately low level of oxygen in their blood at rest and COPD patients who have normal blood oxygen level at rest but low or very low blood oxygen during exercise

Principal Investigator - Dr. M. Turki
Sub Investigator - Dr. C. Alia

STATCOPE

Purpose: a clinical trial designed to determine the effect of 40 mg of daily Simvastatin versus placebo on decreasing the frequency and severity of COPD exacerbations

Principal Investigator - Dr. M. Turki
Sub Investigator - Dr. C. Alia


Diabetic Studies

ELIXA

Purpose: to evaluate the cardiovascular outcomes with a subcutaneous injection of the study drug lixisenatide compared to placebo, in addition to standard of care, in type 2 diabetic patients who experienced an acute coronary syndrome event.

Principal Investigator - Dr. H. T. Dale
Sub Investigator - Dr. B. A. Bhatt 

EXAMINE

Purpose: to evaluate the cardiovascular outcomes following treatment with Alogliptin versus placebo, in addition to standard of care, in patients with type 2 diabetes and acute coronary syndrome

Principal Investigator - Dr. H. T. Dale
Sub Investigator - Dr. B. A. Bhatt

TIMI 53

Purpose: a phase IV study to evaluate if treatment with Onglyza (saxagliptin) versus placebo, in addition to standard of care, can reduce major adverse cardiovascular events in patients with type 2 diabetes

Principal Investigator - Dr. L. Tejada

Sub Investigators


Heart Failure

CARRESS

Purpose: to evaluate the safety and effectiveness of Aquapheresis/ Ultrafiltration or diuretic therapy for the treatment of patients with persistent congestion (fluid buildup) and cardiorenal syndrome (kidney function which is not normal). Aquapheresis/Ultrafiltration is not an experimental procedure.

Principal Investigator - Dr. A. Potash

Sub Investigators


Registries

TRANSLATE-ACS

Purpose: an observational study of patients with acute myocardial infarction (heart attack), managed with percutaneous coronary intervention (PCI) and antiplatelet therapy. The study will examine long-term effectiveness and safety of antiplatelet therapies, post-discharge care patterns and treatment adherence, and associated health care costs.

Principal Investigator - Dr. P. Puleo

Vascular Trials

Ongoing participation in clinical trials, which are closely controlled research studies, allows the vascular specialists at The Vascular Center to test promising new treatments and therapies. The Vascular Center currently participates in several clinical trials including:

SAPPHIRE Trial

Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy for the prevention of strokes in high-risk surgical patients 

The SAPPHIRE Study was the “landmark trial” demonstrating that carotid artery stenting is an effective alternative treatment to open carotid endarterectomy in select patients with cervical carotid occlusive disease. The trial has expanded to include select groups of symptomatic and asymptomatic patients.

For more information about clinical trials, please contact 1-866-960-5980 (toll free) or 610-252-8281.

St. Luke's Heart & Vascular