Clinical Trials

Clinical Trials

The division of Cardiovascular Medicine is participating in the following clinical trials:

AIM-HIGH:Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglyceride and Impact on Global Health. Patients with vascular disease and dyslipidemia are randomized to Simvastatin w/ Niaspan vs Simvastatin w/ placebo

Started 12/13/05       Closed for screening 8/25/09        Study Halted by NIH 5/26/11           
PI:  Allan Simpson, MD

ASTRONAUT: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure.

Started  6/9/09 - current                                                              
PI: James Bergin, MD

ATMOSPHERE: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients with Chronic Heart Failure.

Started  3/10/09 - current                                                      
PI: Allan Simpson, MD

CHAMPION: Cangrelor vs Plavix in ACS patients having PCI.

Started 11-14-06  - Closed to enrollment                                            
PI: Lawrence Gimple, MD

CLOSURE I: Evaluation of the STARFlex® Septal Closure System in Patients with a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a PFO.

Started  3/25/08, CLOSED, FU only                                        
PI: Nin J. Solenski, MD (Neuro)

COSTAR II Trial: CObalt chromium STent with Antiproliferative for Restenosis II Trial -- The purpose of the study is to determine if the COSTARTM coronary stent system works as effectively and safely as the TAXUS Express2 stent.

Started 8/23/05                                                                
PI: Michael Ragosta, MD

EVEREST: Evaluate the safety and effectiveness of an investigational device that repairs the mitral valve.

Started 1/24/06, CLOSED, FU only                              
PI: Scott Lim, MD

FAME: Fractional Flow Reserve vs Angiography for Multi-Vessel Evaluation.

This is a multi-center, international study comparing two clinically acceptable methods for treating patients who will be undergoing stenting for multivessel coronary disease.

Started: 10/24/06, CLOSED, FU only                      
PI: Michael Ragosta, MD

FREEDOM: Study of DM with multi-vessel disease are randomized to CABG vs multiple DES.

Started 8/9/05 - current                                               
PI: Michael Ragosta, MD

GORE HELEX REDUCE: Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients with Patent Foramen Ovale (PFO).

Started: 1/13/09 - current                                           
PI:  Nina J. Solenski, MD (Neuro)

HCRI - DAPT: Placebo controlled drug study to establish a standard of care for blood thinning therapy (Plavix) and PCI and stenting with either DES or BMS.

Started 9/22/09 - current                                                                    
PI: Michael Ragosta, MD

IMPROVE-IT: Patients with ACS randomized to Zocor/placebo vs Vytorin (Zocor/Zetia).

Started: 1/10/06 - current                                                       
PI: Lewis Lipson, MD

INSPIRE ME IAA: INternational Study of Prediction of Intra-Abdominal Adiposity and its RElationships with CardioMEtabolic Risk/Intra-Abdominal Adiposity.

Started:  6/12/07, CLOSED, FU only
PI: Lewis Lipson, MD

KIDS: Blood study to learn more about why some people develop blockages in heart arteries and have MIs and others do not.

Started 5/18/07 - current                                                         
PI: Ellen Keeley, MD

LIVE RED: Less invasive detection and treatment of very early coronary artery disease in patients with diabetes (DM).

Started 3/1/09 - current                                                              
PI: Angela Taylor, MD

PROTECT CA: Open label study reviewing outcomes with the Endeavor Zotarolimus coated stent.

Started 2/24/09 - current                                                       
PI: Lawrence Gimple, MD

PROTECT II - IMPELLA: Evaluate the safety and effectiveness of the IMPELLA RECOVER LP 2.5 System for use during coronary artery interventions compared to intra aortic balloon pump.

Started 4/22/08 - current                                                       
PI: Michael Ragosta, MD

REALISM: A Continued Access Registry of the Evalve MitraClip System: EVEREST II Real World ExpAnded MuLtIcenter Study of the MitraClip System.

Started 1/13/09  - current                                                        
PI: Scott Lim, MD

RE-LY: Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial.

CLOSED, Patients on active drug rolled into RELY-ABLE    
PI: Allan Simpson, MD

RELY-ABLE: Long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial and a cluster randomized trial to assess the effect of a knowledge translation intervention on patient outcomes.

Started 3/28/06 - current                                                           
PI: Allan Simpson, MD

ROCHE: Randomized placebo-controlled study to evaluate effects of Dalcetrapib on cardiovascular risk in stable CHD patients with documented ACS.  Evaluate dalcetrapid in reducing risk of death from cardiovascular disease or having a cardiovascular event.

Awaiting sponsor                                                                          
PI: Lawrence Gimple, MD

SATURN: Patients randomized to Crestor 40mg vs Lipitor 80mg and its effect on atheroma via IVUS at baseline and 24 mos.

Started 2/12/08 - current                                                                
PI: Michael Ragosta, MD

TRILOGY: UA/NSTEMI/ACS for medical management.  MUST be Plavix loaded within 24 hrs of admission to ED.  Randomized to Plavix vs Prasugrel along with ASA.

Started 6/23/09 - current                                                                         
PI: Lawrence Gimple, MD

XIENCE V USA: Evaluate the continued safety and effectiveness of the XIENCETM V Everolimus Eluting Coronary Stent System (the XIENCE V EECSS) recently approved for use by the Food and Drug Administration (FDA) for the treatment of narrowed coronary arteries (blood vessels in the heart) in a group of real-world patients.

Started 7/22/08,  patients rolled over to XIENCE DAPT

XIENCE AV DAPT: Evaluate the safety and effectiveness of the Xience V EECSS; assess the safety and effectiveness of 12 vs 30 months of anti-platelet therapy in patient who have the Xience V EECSS.