TAILOR-PCI | CABANA | Parachute IV | COAPT | GIRAFFE | CARIN | Commander | REPRISE | STRENGTH

Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI)
Aims: This study is looking for participants who underwent a Percutaneous coronary intervention (PCI) procedure initially presenting with either acute coronary syndrome or stable coronary artery disease. The patients will be randomized to one of two groups (with 50:50 chance): the conventional therapy group in which the patients will receive clopidogrel (Plavix) once daily with retrospective genotype analysis performed at the end of one year of treatment; and the prospective genotyping group, in which the patients will have prospective genotyping performed (via a buccal swab) to guide anti-platelet therapy.  Patients in this group who are identified to have reduced function CYP2C19 allele will receive ticagrelor (Brilinta) twice daily and patients with wild type CYP2C19 allele will receive clopidogrel (Plavix) once daily. The participants from both groups will have their genotype tested after one year from a stored blood sample drawn while at the hospital.
The purpose of this study is by using pharmacogenomics (perspective and retrospective genotyping) to determine whether choosing medication (antiplatelet therapy) based on an individual genotype will lead to better outcomes defined as a decrease in major cardiac events in patients undergoing PCI.
Participation in the study will last for 12 months with 3 follow up phone visits. The study is expected to be completed in 2016.
Diagnosis: Percutaneous coronary intervention (PCI) procedure
Principal Investigator/s: Jorge Saucedo, MD (NorthShore University HealthSytem); Naveen Pereira, MD (Mayo Clinic)
IRB Approval Number: EH13-405
Sponsor: Mayo Clinic; Spartan Bioscience, Inc. is providing lab equipment for use in this study
Contact: Ann Joseph, RN, at 847.570.3861 or ajoseph@northshore.org
Open to Enrollment: Yes 

CABANA  (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial)
Aims: This international study is enrolling subjects with symptomatic new onset or under-treated paroxysmal, persistent, or longstanding persistent AF. This is a prospective randomized (1:1) trial comparing primary drug therapy (rate and rhythm control) to catheter ablation. Subject participation can last up to 5 years with follow up at 3 and 6 months and then yearly at NorthShore University HealthSystem.
Diagnosis: Atrial Fibrillation
Principal Investigator: Westby Fisher, MD
IRB Approval Number: EH09-503
Sponsor: National Heart Lung and Blood Institute
Contact: Kathleen Medica, RN, at 847.570.1997 or kmedica@northshore.org
Open to Enrollment: Yes

Parachute IV - PercutAneous Ventricular RestorAtion in Chronic Heart FailUre due to Ischemic HearT DiseasE
Aims: This study is looking for participants who have developed heart failure after a heart attack. The purpose of this study is to evaluate the safety and effectiveness of the Parachute device for the treatment of heart failure due to a previous heart attack. This is a randomized study (50:50) between receiving the device and medical therapy. The Parachute device is implanted in the left  ventricle excluding the non-functional heart segment from the healthy functional segment. This is intended to restore the shape and function of the heart allowing the healthy heart tissue to work more efficiently during each heart beat.
Diagnosis: Heart failure which develops following a heart attack
Principal Investigators: Ted Feldman, MD, and Steven Smart, MD
IRB Approval Number: EH14-046
Sponsor: CardioKinetix, Inc
Contact: Lisa Smalley, RN, at 847.570.2366 or lsmalley@northshore.org
Open to Enrollment: Yes

COAPT-Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation
Aims: This study is looking for participants with leakage of the mitral heart valve due to abnormal valve closure (FMR). The purpose of the study is to compare the performance of the Mitra Clip system plus optimal medical therapy with optimal medical therapy alone. This study is a randomized study (50:50) between receiving the device plus medical therapy and medical therapy.
Diagnosis: Functional Mitral regurgitation with symptomatic Heart failure
Principal Investigator: Ted Feldman, MD
IRB Approval Number: EH12-228
Sponsor: Evalve, Inc, a subsidiary of Abbott Vascular, Inc.
Contact: Lisa Smalley, RN, at 847.570.2366 or lsmalley@northshore.org
Open to Enrollment: Yes

The GIRAFFE Study: Genomic Risk Markers for Atrial Fibrillation Following Extended Cardiac Rhythm Monitoring
Aims: The purpose of the study is to investigate if there is any association between certain regions in one’s DNA (genes) and atrial fibrillation.
The primary objective is to investigate a risk score comprised of approximately 10 small genetic regions (called small nucleotide polymorphisms, SNPs) that are associated with atrial fibrillation at several prior studies and see if they are associated with the development of atrial fibrillation among previously undiagnosed or just diagnosed patients who are at high risk for atrial fibrillation. A secondary objective is to test the association between atrial fibrillation diagnosed in this study with this same subset of genetic regions, previously reported to be associated with atrial fibrillation
Diagnosis:
Patients over 40 years of age who are at high risk for a heart arrhythmia called “atrial fibrillation” (AFib) and are referred for ambulatory heart rhythm monitoring. Patients should either have never been diagnosed with AFib (the heart rhythm monitoring will be performed for up to two weeks using a prolonged-duration ambulatory heart monitoring FDA-approved device, called iRhythm Zio® Patch) or are diagnosed by ECG within a day from enrollment (no monitoring provided).
Principal Investigator: Eli Lavie, MD
IRB Approval Number: EH14-049
Sponsor: Scripps Translational Science Institute, La Jolla, CA
Contact: Elena Genova, PhD, CCRP, at 847.444.5314 or egenova-peeva@northshore.org
Open to Enrollment: Yes

A Prospective, Comparative, Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Phase 2a Study of the Safety and Efficacy of CMX-2043 for Periprocedural Injury Protection in Subjects Undergoing Coronary Angiography at Risk of Radio-contrast Induced Nephropathy (CARIN)
Aims: A randomized, blinded trial to determine the safety and effectiveness of CMX-2043, an investigational drug, in preventing Contrast induced acute kidney injury in patients undergoing cardiac catheterization
Diagnosis: Coronary artery disease and impaired renal function, excluding patients who are on dialysis
Principal Investigator: Jorge Saucedo, MD
IRB Approval Number: EH14-142
Sub-Investigator: Justin Levisay, MD
Sponsor: Ischemix, LLC
Contact: Dana Melgar, RN, at 847.570.2069; Ann Joseph, RN, at 847.570.3861
Open to Enrollment: Yes

A Randomized, Double-Blind, Event-Driven, Multicenter Study Comparing the Efficacy and Safety of Oral Rivaroxaban with Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects with Chronic Heart Failure and Significant Coronary Artery Disease Following a Hospitalization for Exacerbation of Heart Failure (Commander-HF)
Aims: A randomized, blinded study to compare the effectiveness of rivaroxaban 2.5 mg twice a day vs.  placebo in addition to standard therapies for congestive heart failure in preventing the occurrence of heart attack, stroke and death
Diagnosis: Congestive Heart Failure with an admission for exacerbation within 2 weeks of randomization.
Principal Investigator: Jorge Saucedo, MD
IRB Approval Number: EH14-172
Sponsor: Janssen
Contact: Ann Joseph, RN, at 847.570.3861
Open to Enrollment: Yes

REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LotusValve System – Randomized Clinical Evaluation
Aims: Patients that are at high to extreme high risk for standard surgical aortic valve replacement have this opportunity for a less invasive delivery of a new research valve. This is called a TAVR procedure – transcatheter aortic valve replacement. These valves are placed through the femoral artery using conventional catheter techniques.There are commercial TAVR procedures using FDA approved valves. However, with this study we are introducing a new research valve, the Lotus™ Valve. We aim to evaluate the safety and effectiveness of the Lotus™ Valve System compared to the commercially availableCoreValve®. This is a randomized study 2:3 ratio.
Diagnosis: Symptomatic Severe, Calcific Aortic Valve Stenosis
Principal Site and National Co-Principal Investigator: Ted Feldman, MD
IRB Approval Number: EH14-322
Sponsor: Boston Scientific Corporation
Contact: Dale Seifert, RN, at 847.570.2368 or dseifert@northshore.org
Open to Enrollment: Yes

STRENGTH: A Long-Term Outcomes Study to Assess Statin Residual Risk Reduction with EpaNova in High Cardiovascular Risk Patients with Hypertriglyceridemia
Aims: The STRENGTH Trial is a Phase III, multicenter, randomized, placebo-controlled (corn-oil), double-blind study to evaluate the effectiveness of adding omega-3 carboxylic acids (Epanova®) to statin therapy (with or without ezetimibe) for reducing major adverse CV events (MACE)* in adults with persistent hypertriglyceridemia. The time to first occurrence of MACE is the primary outcome measure for the STRENGTH Trial and the time to reach the required number of MACE events will determine the length of the study, which is anticipated to be 3–5 years.
Diagnosis:  Persistent hypertriglyceridemia on maximum tolerated statin dose
Principal Investigator/s: Jorge Saucedo, MD; David J. Davidson, MD
IRB Approval Number: EH14-141
Sponsor: AstraZeneca
Contact: Dana Melgar, RN at 847.570.2069, Evanston Hospital;  224.251.4821, Skokie Hospital or dmelgar@northshore.org
Open to Enrollment: Yes

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