Clinical Trials

CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow Randomized Pilot Trial of the Use of the Distal Protection Device to Prevent Periprocedural MI During Dilation of Coronary Stenosis Caused by Plaques with Large Lipid Cor

Status: open and enrolling

Approval Date: 8/18/2011

Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow) Study is a pivotal trial to evaluate criteria for defining a Lipid Core Plaque (LCP) that is at high risk of rupturing during standard of care therapy and causing intra-procedural complications. If plaques that require treatment are at higher than normal risk of causing intra-procedural complications, some life threatening, the treating physician is better informed and may opt to take precautionary measures to mitigate the risk or result of a complication. The CANARY Study is also designed to evaluate the feasibility of using a distal embolization protection device (EPD) as a means to prevent heart attacks triggered by the embolization of plaque during standard care therapy. It is thought that the EPD will prevent plaque from going downstream during treatment and obstructing other heart vessels. These obstructions could cause heart attacks by preventing blood from reaching heart muscle tissue.

TRANSLATE ACS: Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome Registry

Status: open and enrolling

Approval Date: 8/4/2011

Objective: To determine the effectiveness of prasugrel in comparison to other ADP receptor inhibitors. The study will also determine factors associated with initial ADP receptor inhibitor selection and longitudinal patterns of use, evaluate the safety, and describe and compare resource use and medical costs associated with ADP receptor inhibitors. Additionally, this study will generate a continuum of information from the inpatient to outpatient settings to provide a comprehensive picture of patient treatment and outcomes not currently available for novel ADP receptor inhibitors.

Description: This is a is a prospective, observational longitudinal study to evaluate the real world effectiveness and use of prasugrel and other ADP receptor inhibitor therapies among myocardial infarction (MI) patients treated with percutaneous coronary intervention (PCI) during the index hospitalization. Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. Approximately 17,000 patients will be enrolled at approximately 350 sites in the United States. Follow-up will be conducted through 15 months in approximately 15,650 patients.

Phase III Double Blind Randomized Study to Evaluate Safety and Efficacy of Isavuconazole (BAL8557) versus ACASPOFUNGIN Followed by VORCONAZOLE Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

savuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

Status: open and enrolling

Approval Date: 8/1/2011

The purpose of the study is to compare the safety and efficacy of Isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

NSABP B-47 A RANDOMIZED PHASE III TRIAL OF ADJUVANT THERAPY COMPARING CHEMOTHERAPY ALONE (SIX CYCLES OF DOCETAXEL PLUS CYCLOPHOSPHAMIDE OR FOUR CYCLES OF DOXORUBICIN PLUS CYCLOPHOSPHAMIDE FOLLOWED BY WEEKLY PACLITAXEL) TO CHEMOTHERAPY PLUS TRASTUZUMAB IN

Status: open and enrolling

Approval Date: 7/22/2011

This randomized phase III clinical trial is studying chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer.

SWOG S0337 A PHASE III BLINDED STUDY OF IMMEDIATE POST-TURBT INSTILLATION OF GEMCITABINE VERSUS SALINE IN PATIENTS WITH NEWLY DIAGNOSED OR OCCASIONALLY RECURRING GRADE I/II SUPERFICIAL BLADDER CANCER

Status: open and enrolling

Approval Date: 7/12/2011

This randomized phase III trial is studying gemcitabine to see how well it works when given directly into the bladder compared with a placebo after surgery in treating patients with newly diagnosed or recurrent bladder cancer