Clinical Trials

The GW Heart & Vascular Institute is committed to advancing medical knowledge and improving patient care through research. Our physicians and scientists are involved in a wide range of research efforts from basic cellular research to testing new cardiovascular devices.

The following highlights the clinical trials that have recently been completed or are underway.

RESPECT
Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment

This ongoing study randomizes patients who have experienced a stroke or TIA and who have a patent foramen ovale to standard medical therapy or percutaneous (non-surgical) device closure.

AMEthyst
Assessment of the Medtronic AVE Interceptor Saphenous Vein Graft Filter System

This study investigated the effectiveness of a new filter device designed to trap clot-causing debris in diseased saphenous vein grafts during angioplasty and stenting complications such as heart attack and death caused by debris traveling further down the graft can be reduced by the use of filtering devices.

TRITON TIMI 38
A Comparison of Prasugrel to Clopidorel in ACS

The purpose of this study was to compare an experimental drug called Prasugrel with the standard of care drug Clopidogrel (Plavix) in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI). These antiplatelet therapies are important in preventing recurrence of cardiovascular events following PCI.

TAXUS ATLAS
Evaluation of TAXUS Liberté –SR Paclitaxel-Eluting Coronary Stent System

This study evaluated whether a new drug-eluting stent design can give patients with blocked coronary arteries an outcome comparable to the approved, marketed stent. The Liberté stent was designed to be easier for the physician to deliver and to release the drug in a more uniform manner.

RELY
Randomized Evaluation of Long-Term Anticoagulant Therapy

This study evaluates a new oral anticoagulant drug to determine if it can prevent stroke and other blood clots in patients with documented atrial fibrillation compared to the current standard of care drug, warfarin. Warfarin therapy is complicated by numerous interactions with other drugs and diet requiring lifelong lifestyle modifications and frequent monitoring by blood draw.

ATHENA
Effectiveness of Dronedarone for the Prevention of Hospitalization or Death in Patients with Atrial Fibrillation/Flutter

This study looks at the effectiveness of a new anti-arrhythmic drug, Dronedarone, for restoring sinus rhythm with the goal of preventing cardiovascular hospitalization and death in high-risk patients with atrial fibrillation (AF) and atrial flutter (AFL). Maintaining sinus rhythm decreases unpleasant symptoms, improves cardiac function, and decreases the risk of blood clots originating in the heart.

STEEPLE
Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI) Patients, an International Randomized Evaluation

This trial evaluated the efficacy and safety of enoxaparin versus heparin in patients undergoing non-emergent percutaneous coronary intervention. Compared with heparin, enoxaparin has shown some important benefits, such as a more stable and predictable anticoagulant response which eliminates the need for coagulation monitoring.

APEX-AMI
Evaluation of Pexelizumab in Acute Myocardial Infarction

This study evaluated a new drug, pexelizumab, in patients who have had an acute myocardial infarction and undergo percutaneous coronary intervention. Pexelizumab is a humanized monoclonal antibody aimed at reducing acute inflammatory reactions, thereby limiting tissue damage by reducing cellular destruction and death.

PERISCOPE
Comparing the Effects of Pioglitazone HCl versus Glimepiride on the Rate of Progression of Coronary Artery Disease in Subjects with Type 2 Diabetes Mellitus

The purpose of this study is to compare two approved diabetes drugs to see if either drug causes a change in the atheroma (fatty plaques) in coronary arteries as measured by Intravascular Ultrasound. Diabetics are at increased risk for the development of coronary artery disease, and reduction of plaque size could be an important benefit to consider when choosing a diabetic medication.

PLATO
A Study of Platelet Inhibition and Patient Outcomes

The purpose of this study is to compare an experimental anti-platelet drug with the standard of care drug, clopidogrel (Plavix), in patients with acute coronary syndromes. Antiplatelet therapies are important in preventing recurrence of cardiovascular events following angioplasty and stenting.

CARE
Cardiac Angiography in Renally Impaired Patients

Two contrast agents were compared to evaluate the incidence of contrast-induced nephropathy following cardiac catheterization or angioplasty in patients with pre-existing renal dysfunction. While necessary for the angiographic procedure, contrast agents are known to have the potential to cause kidney damage.