Active Clinical Research

National Institutes of Health Sponsored Trials:

Cardiovascular Inflammation Reduction Trial (CIRT)
CIRT will evaluate whether anti-inflammatory therapy with oral low dose methotrexate (maximum 20 mg daily) will reduce the occurrence of myocardial infarction, stroke, or cardiovascular death in patients with history of coronary heart disease (CHD).  Patients with history of either old myocardial infarction or angiographic evidence of CHD or CABG or PCI in the past 5 years and with type 2 diabetes and/or metabolic syndrome will be eligible to participate.  Methotrexate is a widely used medication taken by millions of older individuals with rheumatoid arthritis for nearly 40 years.  Patients with rheumatoid arthritis receiving low-dose methotrexate seem to have lower rates of heart disease.

Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)
The CABANA trial is being done to determine if catheter ablation is better than drug therapy for treatment of AF.  Both methods (drug therapy and catheter ablation) being compared in this study are considered routine standard of care for treatment of AF. 

GUIDING Evidence Based Therapy Using Biomarker Intensified Treatment (CCC) in Heart Failure (GUIDE IT)
GUIDE IT will determine the efficacy of a strategy of biomarker-guided therapy compared to ususal care in high risk patients with left ventricular systolic dysfunction.

International Study of Comparative health Effectiveness With Medical and Invasive Approaches” (ISCHEMIA)
ISCHEMIA will determine whether invasive strategy of routine early cardiac catheterization with intent for optimal revascularization in addition to optimal medical therapy in patients with stable ischemic heart disease (IHD) and at least moderate ischemia on stress imaging reduces the incidence of recurrent fatal or non-fatal IHD or improving angina control compared to optimal medical therapy alone.

Systolic Blood Pressure Intervention Trial (SPRINT)
Does a treatment program aimed at reducing systolic blood pressure to a lower goal (systolic BP of 120 mmHG) than currently recommended (systolic BP of 140 mmHG) reduce cardiovascular risk, kidney complications, and reduce cognitive decline.

Industry Sponsored Trials:

AngeLmed for Early Recognition and Treatment of STEMI (ALERTS)
The purpose of this study is to evaluate the safety and effectiveness of the Guardian System in comparison to the standard of care in treating subjects with a high risk of a heart attack.  The Guardian device was developed to help reduce the time it takes patients to get to the emergency room when they have a heart attack.  The system works by monitoring the heart’s electrical signal for anything unusual, which may indicate that they are about to or are starting to have a heart attack.  If the Guardian System detects an abnormal heart signal, it will alert them to seek immediate medical care.  The Guardian System is an investigational diagnostic monitor that will be implanted under the skin in the same manner as a pacemaker.  It will register the heart’s electrical signal (or “electrogram”) using a small wire positioned inside the heart. 

Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF)  The main purpose of this research registry study is to investigate the differences between patients that may influence the choice of anticoagulation medication that is selected for the prevention of stroke in patients with atrial fibrillation. Information on important health related events and treatments related to atrial fibrillation in a “real-world” setting and potential side effects of anticoagulant treatment (patients being treated in a doctor’s office as opposed to research data gathered during a controlled research study) will be collected.


A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Trial of Quarterly Subcutaneous Canakinumab in the Prevention of Recurrent Cardiovascular Events Among Stable Post-Myocardial Infarction Patients with Elevated hsCRP (CANTOS)
Canakinumab is being tested to see if it can reduce of cardiovascular disease events in subjects with a history of a heart attack with elevated CRP (inflammatory) blood levels.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR263553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who have Recently Experience an Acute Coronary Syndrome (ODYSSEY Outcomes)
This study will compare the effect of alirocumab with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia.


Efficacy and Safety of LCZ696 Compared to Valsartan on Morbidity and Mortality in Patients with Preserved Ejection Fraction (PARAGON) 
PARAGON will evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure hospitalizations in patients with heart failure with preserved ejection fraction.


A Randomized, Double-Blind, Multinational Study to Prevent Major Vascular Events with Ticagrelor Compared to Aspirin (ASA) in Patients with Acute Ischaemic Stroke or TIA (SOCRATES)
The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor vs aspirin for the prevention of major vascular events (composite of stroke, myocardial infarction and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).


Randomized clinical Trial of RN316 (PF-04950615) in Subjects with Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events (SPIRE-LDL)
This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab to lower LDL-C.


Randomized clinical Trial of RN316 in Subjects with Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events (SPIRE-1)
This study evaluates the PCSK9 inhibitor, Bococizumab, compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 70 mg/dL and < 100 mg/dL or non-HDL-C >/= 100 mg /dl and < 130 mg/dL.


Randomized clinical Trial of RN316 (PF-04950615) in Subjects with Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events (SPIRE-2)
This study evaluates the PCSK9 inhibitor, Bococizumab, compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL or non-HDL-C >/=130 mg/dL.


TReatment with ADP Receptor iNhibotorS:  Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE ACS)
The purpose of this study is to evaluate the effectiveness of clopidogrel (Plavix®) or prasugrel (Effient) and to examine how doctors prescribe these medications for short and long-term use, and to examine how doctors prescribe these medications for short and long-term use.  Antiplatelet medications, such as clopidogrel (Plavix®) or prasugrel (Effient), are approved treatments that block the function of platelets in the blood, and prevent the formation of clots that could block blood flow to the heart.  These medications are often used in patients who have had acute coronary syndrome and who have undergone a procedure called angioplasty or stenting.  The study will look at their medication use and health in the 15 months following their hospitalization for angioplasty.