Clinical Trials

In addition to our laboratory research program we are conducting the following clinical investigations:

    Odyssey is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome. The primary objective of the study is to 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.

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    The study began enrollment in October 2012 and estimated study enrollment is 18,000. Patients must be 40 years of age or older to be eligible for the study.

    Inclusion criteria: Recently (< 52 weeks) hospitalized for ACS.
    The study is sponsored by Sanofi with Regeneron Pharmaceuticals as Collaborator.

    The Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets (IMPACT) aims to determine the best management strategy for patients undergoing cardiovascular intervention. IMPACT will be a prospective randomized trial that will enroll 400 patients post-cardiovascular intervention. The study will compare different cardiovascular prevention strategies of usual care, cardiovascular
    prevention consult, or a motivational interviewing program with tailored text messaging over a 6-month period. The primary endpoint will be non-HDL cholesterol. Secondary endpoints include other lipid values, metabolic risk, smoking cessation, physical activity, nutritional status, and quality of life. IMPACT is funded by a grant from the Rainer Arnhold Foundation and enrollment begun in the spring of 2012.
  • Symplicity Hypertension III Trial
    Symplicity HTN III is a multicenter, prospective, single-blind, randomized controlled clinical study for patients with resistant hypertension. The trial is designed to demonstrate that renal denervation using the symplicity Renal Denervation system is a safe and effective treatment for definite resistant hypertension. In a simple, straightforward procedure, the symplicity catheter is advanced to the renal artery using standard endovascular techniques. The catheter delivers low-power radiofrequency (Rf) energy through the renal arteries, quieting the renal afferent and efferent nerves and reducing the renal contribution to central sympathetic drive, which can consequently reduce blood pressure. The trial will study patients with systolic blood pressure ≥160 mm Hg despite treatment with maximum tolerated doses of three or more antihypertensive medication classes (one of which must be a diuretic). Patients will be enrolled at approximately 60 centers and blinded to their randomized treatment assignments throughout the cath lab procedure (for example, the angiogram also acts as a "sham" procedure. Patients and clinical staff assigned to measure blood pressure will continue to be blinded to treatment status through the six-month follow-up period. Control patients will be given the option to undergo renal denervation after six-month follow-up. Long term follow-up will continue through 36 months.  Please call 212-263-0126 for more information.
    Reduce-it is a prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of AMR101 (EPA only fish oil) on cardiovascular health and mortality.Inclusion Criteria:LDL-C at goal while on statin therapy, established cardiovascular disease (CVD) or at high risk for CVD, hypertriglyceridemia (fasting triglycerides 150 mg/dL to 500 mg/dL, >135 mg/dL to 500 mg/dL if on statins)The primary endpoint will be the occurrence of a first major cardiovascular event of thecomposite endpoint that includes: cardiovascular (CV) death, nonfatalmyocardial infarction (MI), nonfatal stroke, coronary revascularization,unstable angina determined to be caused by myocardial ischemia byinvasive/non-invasive testing and requiring emergent hospitalization.Enrollment is expected to begin this fall.
    The TECOS trial is a research study evaluating the cardiovascular effects of sitagliptin. Eligible subjects are those who have a diagnosis of type 2 diabetes, are at least 50 years old and are taking medications or insulin to lower blood sugar. The study's primary objective is to compare the impact of including sitagliptin as part of usual care vs. usual care without sitagliptin on cardiovascular outcomes. The trial is currently open to enrollment.
  • Platelet Activity in Cardiovascular Disease
    The purpose of this study is to examine platelet activity in patients with cardiovascular disease compared to a normal healthy control population. The trial is currently enrolling healthy individuals for the control comparator group as well as CAD and ACS patients for the other arms of the study. CAD and ACS patients must be on stable aspirin therapy; while, the control subjects are given aspirin 81mg tablets at their third visit to take daily for a week. Control subjects return for a final blood draw at their fourth visit.
    SOLID examines the effects of Darapladib on the stabilization of plaques in a high risk patient population less than 30 days post-ACS. Subjects enrolled in this study met at least one of the following criteria: at least 60 years of age, history of prior MI, taking diabetes required medication, GFR between 30 and 59, or diagnosed with PAD and/or CVD. This study is closed for enrollment.
    The STABILITY is double-blind, randomized trial that evaluates the stabilization of atherosclerotic plaque by initiation of Darapladib therapy. In order to be enrolled, subjects had to have documented chronic heart disease with an additional predictor of cardiovascular risk.  The study is currently in its follow up phase, and is closed for enrollment.