The CentraCare Heart & Vascular Center Research Department opens new clinical trials on a regular basis. For information on these or additional studies that may be open and available to treat, control or prevent heart disease, please contact the research department at (320) 251-2700, ext. 57584 or e-mail wipperj@centracare.com.

A sample of cardiovascular research trials currently open to enrollment at the CentraCare Heart & Vascular Center is listed below.

Prevention Trials

River PCI - The purpose of this study is to evaluate the efficacy of ranolazine as compared to placebo when used as part of standard of care in chronic angina patients with incomplete revascularization post-PCI. Eligible subjects will be randomized 1:1. Dosing of ranolazine or matching placebo will be 500 mg twice daily for 7 days, followed by 1000 mg twice daily for the duration of the study. Subjects on diltiazem or verapamil will receive 500 mg twice daily for the entire duration of the study. Up to 2600 patients will be randomized at an estimated 200 centers. Follow-up will be a minimum of 1 year and will consist of visits at randomization, Month 1, Month 6 and every 6 months thereafter until the end of study.

REVEAL -The purpose of the REVEAL study is to see if raising HDL and lowering LDL reduces the risks of coronary events and strokes. The study will compare anacetrapib 100 mg daily versus matching placebo in 30,000 patients with pre-existing atherosclerotic vascular disease who are also receiving LDL-lowering therapy using atorvastatin. At the initial screening visit, eligible patients will be issued with a 12-week supply of Run-in medication consisting of placebo anacetrapib; and active atorvastatin (either 20 mg or 80mg depending on current cholesterol levels). If the subject is still eligible at the time of randomization, they will be allocated to receive anacetrapib 100 mg or matching placebo along with atorvastatin (at the dose they were on during the run-in phase). Eligible patients will come in for follow-up at 2 and 6 months and then every 6 months for up to 4 years.

Cantos - The primary objective of this study is to demonstrate the superiority of at least one dose of canakinumab compared to placebo in reducing the risk of recurrent major cardiovascular disease events in a population of clinically stable post-MI patients with elevated hsCRP receiving standard of care. Patients eligible for this study will have suffered an acute-MI at least 30 days before randomization and have evidence of systemic inflammation on the basis of a hsCRP > 2 mg/L despite the use of standard of care post-MI medical therapies (lipid lowering, anti-hypertensive, beta blockers, and anti-platelet therapy as defined by local guidelines). Canakinumab is a subcutaneous injection. Patients will be randomized to receive Canakinumab in doses of 50 mg, 150 mg, or 300 mg, or placebo. Patients will be seen for their visits at the CentraCare Heart & Vascular Center Clinic where the visit schedule will consist of screening, randomization, 2 weeks, 3 months and every 3 months thereafter for up to 6 years. Approximately 17,200 patients at up to 1400 study centers will participate in the trial.

Dal-Outcomes 2 - The objectives of this study are to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), CHD risk equivalents or at elevated risks for Cardiovascular Disease and to the assess the long term safety and tolerability of dalcetrapib. Eligible patients will be randomized in a 1:1 ratio to 600 mg of dalcetrapib or matching placebo. Patients will visit the clinic 1 and 6 months after randomization and every 6 months thereafter until completion of the trial. The trial will last until approximately 1,250 patients are anticipated to have experienced a primary endpoint event. This is anticipated to occur 4-5 years after the first patient is randomized. Approximately 20,000 subjects at roughly 700 centers will be recruited to participate.

Pegasus TIMI-54 - The purpose of the study is to compare the effects of long-term treatment with ticagrelor versus placebo on a background of ASA on the event rate of the composite of cardiovascular death, non-fatal MI, non-fatal stroke, or urgent coronary revascularization. The target population for this study includes male/female patients 50 years of age and over with a history of MI 1-3 years ago and at least 1 of the following risk factors: age > 65 years, diabetes, a second prior MI, evidence of multi vessel CAD, or chronic non-end stage renal dysfunction. At Visit 2 (randomization) eligible patients will be randomly assigned to 1 of 3 treatment groups: ticagrelor 90 mg twice daily, ticagrelor 60 mg twice daily, or placebo twice daily. The patient will be followed for a minimum of 12 months and up to approximately 38 months. If a patient enrolled in the study develops an indication for use of an ADP receptor blocker according to medical guidelines, selection of the appropriate agent is at the discretion of the investigator. Principal Investigator: Bernard Erickson, MD

Alecardio - The purpose of this study is to determine whether aleglitazar reduces cardiovascular mortality and morbidity in patients with a recent ACS event and Type 2 Diabetes. The study is an event driven trial and will last at least until all patients are treated for 2.5 years. Study follow-up will consist of a screening period, followed by visits at months 1, 3, 6, 9 and 12 and every 6 months thereafter until the study ends. An estimated total of 6000 patients will be randomized with 3000 patients on active treatment and 3000 patients in the placebo group. The study will be conducted in approximately 600-900 sites worldwide. Principal Investigator: Timothy Schuchard, MD

PROMISE - A multicenter, randomized pragmatic trial comparing two state-of-the-art diagnostic strategies in approximately 10,000 symptomatic, low to intermediate risk subjects with suspected Coronary Artery Disease who require non-urgent testing. The investigational arm will use an “anatomic” testing strategy with coronary CTA (> 64 slice) as the initial test. The usual care or “functional” testing strategy will use either stress imaging (echocardiography or nuclear) or exercise ECG as the initial test. All subsequent diagnostic and therapeutic management will be at the discretion of the treating physician. The trial will encourage adherence to evidence based practice and document actual therapies used, but will not mandate specific care plans which will be left to the treating physician. Subjects will be randomized over approximately 24 months and followed for 24-48 months. Principal Investigator: Jamie Pelzel, MD

Translate - The overall goals of TRANSLATE-ACS are to examine in-hospital and longitudinal outcomes of Acute-MI patients managed with PCI, as well as to assess post-discharge care patterns and treatment adherence. In particular, the registry will examine how physicians are making treatment choices between marketed ADP receptor inhibitors; factors influencing downstream continuation of and adherence to these medications; and real-world effectiveness, safety, and health care costs in broad-based patient population. Selected clinical variables, baseline characteristics, medications, clinical procedures, standard laboratory parameters, and clinical outcomes will be collected at baseline. Approximately 17,000 patients will be enrolled across 350 hospitals in the United States. After hospital discharge, patients will be contacted via telephone at 6 weeks, 6 months, 12 months and 15 months to assess interim events and medications. Events of interest include death, MI, stroke, repeat revascularization procedures and bleeding. All follow-up will be conducted centrally by a DCRI call center. Patient-reported events will be supplemented by hospital bill collection (usually in the form of a UB-40) from the admitting hospital. Discharge diagnoses established via the ICD-9 code on the medical bill suggestive of the above endpoints will trigger addition medical record collection to permit clinical validation of patient reported outcomes by an independent reviewing clinician at DCRI. Principal Investigator: Bernard Erickson, MD

Tecos Study - The purpose of this study is to test the safety and effectiveness of Sitagliptin (trade name JANUVIA™) in patients with Type 2 Diabetes with a history of cardiovascular disease. Sitagliptin is an FDA approved drug available by prescription for control of blood sugar for those with Type 2 Diabetes. Patients will be randomized to receive either Sitagliptin or Placebo in addition to their normal standard of care. The dose of Sitagliptin (100 mg or 50 mg) will be determined by the patients kidney function and may be adjusted. Patients will return for study visits at Month 4, Month 8, Month 12, and then every six months until the end of study visit. Patient may be in the study up to 6 years. Principal Investigator: Bernard Erickson, MD

DAPT Study - The purpose of this study is to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI). Subjects may be enrolled into the study either before or after the index procedure. Enrollment can occur up to 24 hours post procedure. All enrolled subjects will be treated with either a drug eluting or bare metal stent and assigned to 12 months of open label DAPT treatment in addition to aspirin. All enrolled subjects who are considered “12 Month Clear” are eligible for randomization to either placebo or an additional 18 months of DAPT treatment. Both arms will continue with aspirin therapy. “12 Month Clear” is defined as subjects who are event free (from all death, MI, stroke, repeat coronary revascularization, stent thrombosis and major bleed). Follow-up will consist of telephone and clinic visits for 18 months followed by an additional 3 month observational period. Principal Investigator: Bernard Erickson, MD

PRECISION Study - The purpose of this study is to assess the effects of celecoxib (CELEBREX) when compared to traditional (non-selective) nonsteroidal anti-inflammatory drugs on cardiovascular events, gastrointestinal events, renal events and symptomatic benefits in subjects with osteoarthritis or rheumatoid arthritis with cardiovascular disease or at high risk for developing CVD. Patients will be randomized to receive one of three sets of the following study drugs: celecoxib, ibuprofen, or naproxen. The testing of celecoxib compared to ibuprofen, or naproxen is investigational. The overall study length is anticipated to last 36 – 42 months. Principal Investigator: Bernard Erickson, MD

Prospective Evaluation of Heart Failure Patients with Central Sleep Apnea - A Non-significant Risk Observational Study: The purpose of this study is to evaluate the natural progression of disease in heart failure (HF) patients with moderate to severe central sleep apnea. Up to 40 subjects will be enrolled at up to eight centers.

Subjects will undergo PSG screening to determine initial eligibility for the trial. Other baseline evaluations include: a physical exam and simple blood test, HF assessment and classification, 3 standardized questionnaires, a standard echocardiogram, and the six-minute hall walk. Post enrollment subjects will receive phone calls every week for the first month and at 2 months to determine clinical status and assess for adverse events. The 3 & 6 month follow-up requires in-person visit for reassessment similar to the baseline evaluation. Principal Investigator: Jenny Bauerly, CNS

Heart Failure Trials

EXACT-HF - The purpose of this study is to determine if allopurinol, taken once a day, will benefit patients with chronic heart failure and elevated serum uric acid levels. Allopurinol is approved by the FDA and has been used for many years in the treatment of gout. Recent studies suggest that allopurinol may also improve symptoms and exercise capacity in patients with heart failure by lowering their uric acid levels. The use of allopurinol for heart failure is considered investigational. This is a randomized, double-blind study that will involve approximately 250 subjects. These subjects will be followed for up to 6 months. Principal Investigator: Tim Schuchard, MD

CARRESS-HF - The purpose of this study is to test if ultrafiltration compared to stepped pharmacologic care will result in improved renal function and relief of congestion in patients hospitalized with acute decompensated heart failure (ADHF) and cardiorenal syndrome. Subjects will be followed through the duration of their hospitalization and will also be asked to return to the clinic at 30 days and 60 days after enrollment. Principal Investigator: Tim Schuchard, MD

Intervention Trials

GE 145-002 - The purpose of this study is to evaluate the cardio-renal and overall safety profile of GE-145 320 mg I/mL Injection when compared to iopamidol 370 mg I/mL, a low-osmolar ICM. The study will focus on elderly subjects (>70) with either chronic renal insufficiency, or Diabetes Mellitus requiring drug therapy, or decreased cardiac function defined as systolic ejection fraction <50% or CHF, who are referred for a coronary catheterization procedure with or without PCI. Approximately 250 subjects in up to 30 centers in North America will be enrolled in the study. All enrolled subjects will be randomized to receive either GE-145 320 mg I/mL or iopamidol 370 mg I/ML for their CATH procedure, which will be performed according to medical need and the standard of care at our center. The contrast media will be administered according to our centers standard of care. Subjects will be evaluated at baseline and will be closely monitored for safety throughout their participation to 7 days post contract administration. The safety evaluation includes medical/surgical history, concurrent medications, physical exam, vital signs, ECG’s, lab tests, biomarker tests and AE monitoring. Principal Investigator: Bernard Erickson, MD

CloSys - The purpose of this study if to evaluate the safety and efficacy of the CloSys Hemostasis Device (HD) as an adjunct to standard compression in achieving Hemostasis at the femoral access site. Medical devices are commonly used to stop bleeding at the access-site. The CloSys HD is different from other medical devices in that is does not use mechanical closure or drugs to stop bleeding at the access site. CloSys HD removes Heparin from a small amount blood at the access-site in the groin. The device then inserts the de-heparinized blood back into the access-site allowing the body’s natural clotting system to take over and stop the bleeding. A key advantage of the CloSys HD is that it can be used immediately post procedure; unlike standard compression, which requires a lengthy wait period for the ACT level to decline to appropriate levels. The study is expected to enroll 130 patients at up to 10 hospitals across the United States. Patients will be followed for 30 days post-procedure to collect necessary study data and assess any adverse events. Principal Investigator: Bernard Erickson, MD

Premium - The objective of this study is to evaluate whether percutaneous PFO closure is effective in reducing the incidence of disabling migraine headaches in subjects. The purpose will be evaluated by investigating whether subjects who have their PFO closed experience a significant reduction in migraines over a 12 month period compared to those who were randomized to the sham procedure. The PREMIUM Trial will enroll at total of 230 subjects at up to 45 institutions. All subjects will be followed from the time of consent until discontinuation or completion of all study requirements. Subjects enrolled in the study will be evaluated at baseline, pre-discharge, 1, 4, 6, 8, 10, 11 and 12 months. Principal Investigator: Jacob Dutcher, MD

Sapphire-WW - This study utilizes the Cordis PRECISE® Nitinol Stent Systems, the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire and next generation Cordis carotid stents and EPDs as they become commercially available. The study population will consist of high-surgical risk patients with atherosclerotic disease of the carotid artery(ies). Subjects will be seen in follow-up at 30 days and have a telephonic interview conducted a 12 months to establish the occurrence of any major adverse events. The study is expected to enroll 10,000 patients at 350 sites. Principal Investigator: Bernard Erickson, MD

Device/Electrophysiology Trials

PainFree SST - Patients who would benefit from or have already received a Medtronic Protecta™ Implantable ICD or Protecta™ CRT-D device may be eligible to participate in this study. The purpose is to evaluate the rate of inappropriate shocks at one year post implant and summarize safety equivalence of ventricular fibrillation number of intervals to detection (VF NID) programming in secondary prevention patients. Quality of Life, Health Care Utilization, syncopal events and reasons for inappropriate shocks will be analyzed. Approximately 3,000 patients worldwide will participate in this study. Follow-up for the study will occur every 6 months until the last subject enrolled completes their 12 month follow-up. Principal Investigator: Simón Milstein, MD