Division of Cardiology

Clinical Trials Activities


DAL-301

A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trial.

Protocol Number:  Dal-301

Principal Investigator:  Bassam Omar, MD, PhD

Awaiting IRB approval

Objective:  to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality (cardiovascular death, resuscitated cardiac arrest, non-?- fatal myocardial infarction (MI) and non-?-fatal stroke) in subjects with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene.

 

VOYAGER

An international, multicenter, randomized, double-blind, placebo-controlled phase 3 trial investigating the efficacy and safety of rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures. VOYAGER PAD

Protocol Number:  BAY 59-7939/17454 

Principal Investigator:  Ghulam Mustafa Awan, MD

Mar 2016 – currently enrolling

Objective:  to evaluate whether rivaroxaban added to acetylsalicylic acid (ASA) is superior to ASA alone in reducing the risk of major thrombotic vascular events (defined as myocardial infarction (MI), ischemic stroke, cardiovascular (CV) death, acute limb ischemia (ALI), and major amputation of a vascular etiology) in symptomatic PAD patients undergoing lower extremity revascularization procedure.

 

ARTEMIS

Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study

Protocol Number:  D5130R00030

Principal Investigator:  Ghazanfar Qureshi, MD

June 2015 – currently enrolling

Objective:  to determine if patient copayment reduction leads to lower risk of MACE (composite of death, AMI, and stroke) at one year after discharge.  To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at one year after discharge.

 

GLORIA-AF

Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients with Atrial Fibrillation

Protocol Number:  1160.129

Principal Investigator:  Michael V. Cohen, MD

JAN 2014 – currently enrolling

Objective:  to investigate the patient characteristics influencing the choice of antithrombotic treatment for the prevention of stroke in non-valvular atrial fibrillation (AF) patients.  To collect real world data on important outcome events of antithrombotic treatments for the prevention of stroke.

 

ODYSSEY

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

Protocol Number:  EFC11570

Principal Investigator:  Christopher Malozzi, DO

Enrollment Closed

Objective:  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 an LMT regimen that is statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of these given statins and optimized for long-term chronic use with other non-statin LMT(s) at investigator’s discretion.



For information please contact Cherie Revere at (251) 471 - 7027

 

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