Accelerate: Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High-Risk for Vascular Outcomes

Short Description: This trial studies a new medication, evacetrapib, that increases high-density lipoprotein cholesterol (HDL-C) ("good" cholesterol) and decrease low-density lipoprotein cholesterol (LDL-C) ("bad" cholesterol). Epidemiologic data shows that high levels of good cholesterol and low levels of bad cholesterol may lower the risk of having a Major Adverse Cardiovascular Event (MACE). The objective is to determine whether evacetrapib can help patients with High Risk Vascular Disease (HRVD) and to collect DNA for future research. The study is double blinded so neither the subject nor the study physician will know if the subject is taking placebo or the investigational drug. This is a multicenter randomized drug study with an estimated enrollment of 11,000 patients with HRVD.

Principal Investigator: Giora Weisz, MD

River PCI: Evaluation of the efficacy of Ranolazine vs. Placebo in chronic angina subjects with incomplete revascularization post PCI

Short Description: The study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy to treat chest pain in patients with incomplete revascularization post-percutaneous coronary intervention (PCI). PCI, commonly known as coronary angioplasty, is a therapeutic procedure used to treat blocked coronary arteries of the heart for patients who have coronary heart disease. For this study, incomplete revascularization is defined as a visually estimated greater than or equal to 50% blockage that remains in one or more of the coronary arteries after the PCI procedure is complete. The study design is randomized, double-blind and placebo-controlled. Up to 2600 patients at will be randomized at approximately 200 sites to either study drug or placebo on a 1:1 basis or 1300 patients per treatment group. Following PCI, subjects will be treated with standard medical therapy. The primary endpoint is reduction in major adverse cardiovascular events (MACE). The dosing regimen of ranolazine is currently approved in the US for treatment of subjects with chronic angina.

Principal Investigator: Manish Parikh, MD

Alecardio: Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D)

Short Description: In long term follow up. Alecardio is a drug study examining the potential of an investigational drug ‘Alecardio’ in improving cardiovascular outcomes in patients with diabetes who had a recent cardiovascular event (UA, NSTEMI or STEMI).

Principal Investigator: Giora Weisz, MD






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