Clinical Trials

ACTIVE TRIALS

Image of Exam Room in 9U Prevention Center

  1. ODYSSEY DM-Dyslipidemia Clinical Trial Program
    We are enrolling patients in a study that tests a new medication for lowering “bad” cholesterol (LDL) in diabetic patients. The medication, alirocumab, has already been approved by the FDA for patients with or at risk of heart disease. This particular clinical trial is for patients who have type 2 diabetes and high LDL cholesterol levels not adequately controlled by statin treatment. Patients should be on a stable regimen of glucose lowering treatments for type 2 diabetes and taking a statin medication (or cannot take a statin) without other cholesterol lowering treatments. Please contact the study for further information at 646-501-0244.
     
  2. PACE Trial: Platelet Activity in Vascular Surgery and Cardiovascular Events
    A prospective study to assess the association between platelet activity in subjects before and after vascular surgery with incident cardiovascular and bleeding events. Pathological and clinical studies have consistently demonstrated that abnormalities in platelet activity play a major role in the pathogenesis of atherosclerosis and atherothrombosis. Screening for abnormalities in thrombosis and hemostasis by measuring platelet activity, thrombin generation, and markers of coagulation have been proposed to identify individuals at high-risk for cardiovascular events, however, it remains a research tool not ready for implementation in standard care. This study will add to the growing understanding of platelet activity and markers of coagulation in cardiovascular disease; examine a comprehensive battery of platelet activity markers, markers of coagulation, and inflammatory biomarkers in subjects undergoing vascular surgery; and will provide important data on the mechanism of increased platelet activity using mRNA and microRNA expression profiling.
     
  3. Platelet Activity and Thrombosis Registry & Prevention Biorepository 
    A prospective registry of patients with early cardiovascular disease. A biorepository of platelet activity, platelet RNA, whole blood RNA and DNA is being stored in all individuals. This repository will enable us to better understand potential mechanisms of early onset of cardiovascular disease.
     
  4. Antiplatelet Therapy HIV
    We are investigating why subjects with HIV are at higher risk for heart disease, and more specifically, can the study of platelets and their manipulation via platelet inhibiting drugs (aspirin versus clopidogrel) improve platelet function and immune function in those with active HIV.
     
  5. HONOR Trial: Patient Centered Home Exercise Program for Peripheral Artery Disease
    We are a site for a Patient Centered Outcomes Research Institute (PCORI) funded randomized controlled trial testing whether a home-based exercise program significantly improves walking performance and other patient-centered outcomes in patients with peripheral arterial disease, compared to usual care.
     
  6. EMERALD-D study: Environmental Exposures and Cardiovascular Disease in Diabetes
    A cross-sectional study with an optional follow-up repository timed with clinical labs for diabetes, this study will investigate the vascular effects of environmental exposure among patients with diabetes and establish a biorepository to explore novel CVD risk factors among patients with diabetes.  This study will contribute to the growing understanding of environmental exposures as modifiable risk factors for CVD.
     
  7. Effects of bariatric surgery on platelet characteristics and function
    We are examining platelet-specific activity and inflammatory gene expression prior to and following weight loss surgery in obese patients, a group that is at increased risk for thrombosis. This study will provide data on platelet-specific changes which occur following bariatric surgery. This preliminary data will be used in the design of a larger, definitive study of platelet-specific characteristics and thrombosis risk in obese subjects undergoing weight loss.

TRIALS IN FOLLOW-UP

  1. ODYSSEY
    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. The study began enrollment in October 2012 and total estimated study enrollment is 18,000. NYU as a site aims to enroll 30 patients and has enrolled 11 so far.
    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 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.
    The study is sponsored by Sanofi with Regeneron Pharmaceuticals as Collaborator.
     
  2. REDUCE-IT
    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 the composite endpoint that includes: cardiovascular (CV) death, nonfatalmyocardial infarction (MI), nonfatal stroke, coronary revascularization, unstable angina determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. Nine patients have enrolled to date.
     
  3. VERTIS-CVO
    This study assess the effect of ertugliflozin as compared with non-erthugliflozin comparator group on the time to first occurrence of fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, hospitalization for a primary diagnosis of heart failure, individual components of MACE plus (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina). Nine patients enrolled at NYU, and the study is closed to accrual at this time.
     
  4. Pivotal Trial: Platelet Activity in Vascular Surgery – Thrombosis and Bleeding
    This study focuses on patients with vascular disease in different arterial territories, including peripheral artery disease, carotid artery disease, abdominal aortic aneurysm. We measure platelet activity and cardiovascular risk before and after vascular surgery.
     
  5. 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.
     
  6. Effect of bariatric surgery on HDL function in cholesterol efflux in obese women with and without the metabolic syndrome
    This study assess the effects of Roux-en-Y Gastric Bypass and Sleeve Gastrectomy on HDL cholesterol efflux capacity.

CLOSED TRIALS

  1. IMPACT 
    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. 400 enrolled in this trial. 
     
  2. APPROACH 
    This randomized phase III trial evaluates the efficacy on antisense oligonucleotide (ASO) drug ISIS 304801 (300 mg once weekly) in patients with familial chylomicronemia syndrome (FCS) as compared to placebo in reducing fasting triglycerides, risk of developing pancreatitis, and other symptoms of FCS. This drug inhibits liver production of apoC-III. We will enroll a small number of patients (10>) with this rare metabolic condition. The patients will be screened for genetic defects in lipoprotein lipase and will have their lipoprotein lipase enzyme measured in postheparin blood.
     
  3. TECOS
    The TECOS trial evaluated the cardiovascular effects of sitagliptin. Subjects included those with a diagnosis of type II diabetes, 50 years of age or greater, and on medications or insulin to lower blood sugar. The study's primary objective was to compare the impact of including sitagliptin as part of usual care vs. usual care without sitagliptin on cardiovascular outcomes.
     
  4. SOLID TIMI
    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.
     
  5. STABILITY
    The STABILITY is double-blind, randomized trial that evaluated 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.