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Telephone: 540-981-2105 or toll-free 800-981-2105
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The RHI emphasizes the application of advanced pharmacological means of prevention as well as treatment of cardiovascular diseases. We always use proven therapies first at the RHI. However, you may also have access to new tests or treatments under clinical investigation in studies either sponsored through the National Institutes of Health or approved by the Food and Drug Administration. New tests and treatments are only used with your consent. Our active studies are listed below for your information. Note that there are detailed inclusion and exclusion criteria for each study, and these will be examined if you otherwise qualify for participation. STICH "Surgical Treatment for Ischemic Heart Failure." Sponsor: NIH / NHLBI, Duke Clinical Research Institute. Enrollment completed. RED-HF "A Double-Blind, Randomized Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin alfa Treatment on Mortality and Morbidity in Heart Failure Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia. Sponsor: Amgen. Inclusion: Patient must be a male or female greater than or equal to 18 years of age with heart failure of at least three months duration; LV Ejection Fraction of less than or equal to 35%; Hemoglobin concentration between 9 and 12 grams/deciliter.
PRECISION "Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen- A Randomized, Double Blind, Parallel-Group Study of Cardiovascular Safety In Osteoarthritis or Rheumatoid Arthritis Patients With or at High Risk for Cardiovascular Disease Comparing Celecoxib With Naproxen and Ibuprofen.” Sponsor: Pfizer and Cleveland Clinic Cardiovascular Coordinating Center. Inclusion: Patient must be a male or female >18 years of age, with osteoarthritis or rheumatoid arthritis as well as a high risk of (or pre-existing) atherosclerotic vascular disease.
ARISTOTLE
"A
Phase III, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm
Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and
Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation." Sponsor:
Bristol-Myers Squibb. Enrollment completed. TRILOGY ACS "A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) Who are Medically Managed – The TRILOGY ACS Study." Sponsor: Lilly. Inclusion: Patient must be a male or female >18 years of age, with a recent episode of unstable angina or a non-ST-elevation myocardial infarction (within seven days) for whom a medical management strategy has been determined to be most appropriate. dal-OUTCOMES
"A
Phase III, Double-blind, Randomized Placebo-controlled Study, to Evaluate the
Effects of RO4607381 on Cardiovascular (CV) Risk in Stable CHD patients, with a
Documented Recent Acute Coronary Syndrome (ACS)
."
Sponsor: Roche. Enrollment completed. AXIOM-ACS "
A Phase 2, Double-blind, Randomized Placebo-controlled Study of the Safety and
Efficacy of TAK-442 in Subjects with Acute Coronary Syndromes."
Sponsor: Takeda. Enrollment completed. ASPECT "A Phase III, Randomized, Double-Blind Crossover Trial of Apadenoson for the Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI.) Sponsor: PGxHealth. Inclusion: Patient must be a male or non-pregnant female >18 years of age referred for a stress radionuclide examination of the heart due to the suspicion of significant coronary artery disease. EXAMINE "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome." Sponsor: Takeda. Inclusion: Patient must be a male or female >18 years of age with type 2 diabetes mellitus and a history of acute coronary syndrome within 15 to 60 days prior to randomization.
Sanofi-Aventis EFC11319 "A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate Cardiovascular Outcomes During treatment with Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome." Sponsor: Sanofi-Aventis. Enrolling Summer 2010. Inclusion: Patient must be a male or female >18 years of age with type 2 diabetes mellitus and a history of acute coronary syndrome within 5 days to 12 weeks prior to randomization. RIVAROX-ACS-3001"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects with Acute Coronary Syndrome." Sponsor: Johnson & Johnson. Enrolling Summer 2010. Inclusion: Patient must be a male or female >18 years of age with a history of recent acute coronary syndrome. |
® The "heart & star" is the registered mark of the RHI
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