Current Clinical Trials

ALTITUD

Novartis Pharmaceuticals trial entitled: A randomized, double-blind, placebo-controlled, parallel-group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality.

ALTITUDE: ALiskiren Trial In Type 2 diabetes Using cardio-renal Disease Risk.

PI: Ali Bazzi, MD, PI: Kevin Coy, MD

M&M

A phase III, double-blind, randomized placebo-controlled study, to evaluate the effects of RO4607381 on cardiovascular risk in stable CHD patient

Patient recently hospitalized for ACS and whose residual cardiovascular risk may benefit from increase in HDL-C.

PI: Ali Bazzi, MD

IMPROVE-IT

A Multicenter, double blind, randomized study to establish the clinical benefit and
Safety of VITORIN (Ezetimivebe/Sinvastatin tablet) Vs Simvastatin monotherapy in
high risk subjects presenting with ACSPrimary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin combination compared to simvastatin in stabilized acute coronary syndrome subjects – either acute MI or unstable angina.

Pi: Ali Bazzi, MD, PI: James Margolis, MD

PRECISION

The PRECISION Study is a double-blind, triple-dummy, randomized, multicenter study to assess the effect of celecoxib (COX-II selective inhibitor) when compared to traditional (nonselective) nonsteriodal anti-inflammatory drugs (NSAIDs) on cardiovascular events, gastrointestinal events, renal events and symptomatic benefit in approximately 20,000 male and female subjects with osteoarthritis (OA) or rheumatoid arthritis (RA) with cardiovascular disease (CVD) or at high risk for developing CVD.

PI: James Margolis, MD

AQUARIUS

A 104 week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of aliskiren on the progression of atherosclerosis in patients with coronary artery disease when added to optimal background therapy This study is designed to provide an assessment of the effect of aliskiren, in addition to optimized background therapy, compared to placebo on the progression of coronary atherosclerosis (defined as change from baseline in percent atheroma volume) as assessed by IVUS in patients with CAD and blood pressure in the pre-hypertensive (high normal) range. The relationship between changes in coronary atheroma volume and cardiovascular endpoints will also be explored. In addition, the study will provide an evaluation of the long term safety and tolerability of aliskiren in a CAD population.

PI: James Margolis, MD

LSR of ACUITY spiral

Longitudinal Surveillance Registry of the ACUITYTM Spiral Lead LSR of ACUITY Spiral.

The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term reliability and clinical performance of BSC’s ACUITY Spiral Lead. Additionally system related information will be collected in this registry. The objective of the LSR of ACUITY Spiral is to prospectively evaluate the complication-free rate of the ACUITY Spiral Lead to verify long-term performance.

PI: Luis Rechani, MD

ASSURE1

ApoA1 Synthesis Stimulation in AcUte CoRonary SyndromE Patients Phase II multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial for the assessment of lipid and coronary plaque changes with RVX000222 in patients with acute coronary syndrome events.

PI: James Margolis, MD

dal-PLAQUE-2

A Phase III, Multi-center, Double-Blind, Randomized, Placebo-controlled Study, Evaluating the Effect of Treatment with Dalcetrapib 600 mg on Atherosclerotic Disease as Measured by I. Coronary Intravascular Ultrasound (IVUS) and Quantitative Coronary Angiography II Carotid B-Mode Ultrasound intima media thickness (IMT) and total plaque volume in Subjects Undergoing Coronary Angiography who have Coronary Artery Disease.

PI: James Margolis, MD

VEST-PREDICTS

Vest prevention of Early Sudden death Trial (VEST) and PREDiction of ICD Therapies Study (PREDICTS)
to conduct a multicenter, randomized controlled trial to test the hypothesis that a non-invasive wearable automatic defibrillator vest will reduce overall mortality in the first 60 days following an MI in participants with left ventricular dysfunction (EF≤35%).

PI: Luis Rechani, MD

HOPE 4 HF

Health Outcomes Prospective Evaluation for Heart Failure with EF ≥ 40% (HOPE4HF)
The CVRx Health Outcomes Prospective Evaluation for Heart Failure with EF ≥ 40% (HOPE4HF) is a prospective, randomized trial of approximately 540 subjects randomized at up to 70 U.S. sites and up to 20 sites outside of the U.S. Subjects will be randomized in a 2:1 ratio to receive a Rheos system plus medical management (Device Arm) or to receive medical management alone (Medical Management Arm). No more than 10% of the subjects can be randomized at any one site.

PI: James Margolis, MD

TIMI 54 PEGASUS

A phase III, international trial of a new oral P2Y12 inhibitor ticagrelor in patients with a history of myocardial infarction 12-36 months in the past. The trial is led by the TIMI Study Group and sponsored by AstraZeneca. The trial called, PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome), is a randomized, double-blind, placebo-controlled study. The primary endpoint will be the composite of cardiovascular death, myocardial infarction, or stroke.

PI: James Margolis, MD

Protocol H7T-MC-TABY(b)

A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) Who are Medically Managed – The TRILOGY ACS Study Prasugrel hydrochloride (LY640315) Study H7T-MC-TABY(b) (TRILOGY ACS) is a Phase 3, multicenter, randomized, parallel-group, double-blind, double-dummy, active-controlled study in subjects who have experienced recent (within 10 days) unstable angina/non-ST-elevation myocardial infarction (UA/NSTEMI) acute coronary syndromes (ACS) and who are to be medically managed. Eli Lilly and Company.

Pi: Ali Bazzi, MD

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