Clinical Trial Descriptions - VA New England Healthcare System
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VA New England Healthcare System

 

Clinical Trial Descriptions

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Listing and description of clinical trials underway within the Clinical Trials Network.
Study Short NameFull NameSitesDescriptionSponsorClinicaltrials.gov ID
PARAGON-HF Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction (PARAGON-HF) BOS, PRO, WH, WRJ Evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction. Novartis NCT01920711
CAT-IQ Cancer Associated Thrombosis and Isoquercetin (CAT IQ) BOS, PRO, WH, WRJ, TOG, MAN Evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots), in participants who have pancreas, non small cell lung cancer or colorectal cancer. Dana-Farber NCT02195232
ISCHEMIA International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) BOS The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~8000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT. NYU School of Medicine NCT01471522
SWOG Lung Map Lung-MAP: S1400 Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IIIB-IV Squamous Cell Lung Cancer BOS, PRO, WH, WRJ, TOG, MAN This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study "Master Protocol". The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval. SWOG NCT02154490
Serelaxin Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients (RELAX-AHF-EU) BOS This is a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF). Novartis NCT02064868
EpiFix Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers BOS, BED, WH, TOG, PRO The objective of this study is to evaluate the percentage of patients with complete diabetic foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone. MiMedx NCT01693133
POP Precision Oncology Research Program BOS, PRO, WH, WRJ, TOG, MAN A research data repository will be created by combining patient medical history information with data from tumor sample genomic analysis.  This data repository will then be shared with academic, industry, and third-party groups to allow for generalizable research, personalized treatment, and clinical trial matching. VA N/A
Alliance 041202 CLL Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia WH, WRJ This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab, can block cancer growth in difference ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet know whether rituximab with bendamustine hydrochloride is more effective than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia. NCI NCT01886872
Alliance 031201 Prostate Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer WH, WRJ This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body. Alliance NCT01949337
SWOG 0820 PACES S0820, Adenoma and Second Primary Prevention Trial (PACES) WH, WRJ The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer. SWOG NCT01349881
FOURIER Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) WRJ The primary hypothesis is that additional LDL-C lowering with Evolocumab (AMG 145) when used in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization in subjects with clinically evident cardiovascular disease. Amgen NCT01764633
CALGB 70807 (Prostate Diet) Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance WH Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.  This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance. Alliance NCT01238172
CALGB 90203 (Prostate) Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer WH Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer.  This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer. NCI NCT00430183
MVP Million Veteran Program WRJ, CWM, MAN, TOG, BED MVP is a national, voluntary research program funded entirely by the Department of Veterans Affairs Office of Research & Development. The goal of MVP is to partner with Veterans receiving their care in the VA Healthcare System to study how genes affect health. To do this, MVP will build one of the world's largest medical databases by safely collecting blood samples and health information from one million Veteran volunteers. Data collected from MVP will be stored anonymously for research on diseases like diabetes and cancer, and military-related illnesses, such as post-traumatic stress disorder. VA N/A
Cognitive Aging Maintaining Cognitive Health in Aging Veterans BOS, BED Interventions aimed at disseminating information about cognitive aging and lifestyle factors that contribute to successful cognitive aging, in addition to providing broad cognitive skills training, may improve the psychological wellness and day-to-day functioning of the aging veteran population. This 12-week course aims to teach older veterans (age 65+) about brain aging, lifestyle factors that contribute to successful aging, and techniques that can boost cognition in daily life. VA NCT02023944
Zonisamide Effectiveness of Zonisamide in Alcohol Dependent Veterans BED, WH This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication zonisamide for the treatment of heavy drinking alcoholic veterans. VA NCT02368431
SMART A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Out Comes? (SMART) WRJ Randomized trial to evaluate impact of healthcare provider( clinician and nursing staff) support and education on treatment discontinuation rates in the absence of progression in patients with metastatic colorectal cancer treated with regorafenib. Intensified education and support will be provided through an application for iPad which has automatic links to grading, dose reduction and side effect management ,as well as, references for additional articles. Bayer NCT02287025
MDS/AML Connect MDS/AML Disease Registry WRJ The purpose of the Connect® MDS/AML Disease Registry is to provide unique insights into treatment regimens and sequencing of these regimens as they relate to clinical outcomes of patients with newly diagnosed MDS or AML in routine clinical practice and evaluate molecular and cellular markers that may provide further prognostic classification and/or might be predictive of therapy outcomes. Celgene NCT01688011
CSP 590 Lithium for Suicidal Behaviors in Mood Disorders BOS Participants will be patients with bipolar disorder or depression who have survived a recent episode of suicidal self-directed violence or were hospitalized specifically to prevent suicide. Randomly, half will receive lithium, and half will receive placebo. The investigators are primarily interested in whether lithium leads to increases in the time to the first repeated episode of suicidal behavior, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide. In addition, this study will allow us to explore whether lithium decreases the total number of suicidal behaviors, and whether it has comparable effects on impulsive and non-impulsive behaviors. If there is an effect of lithium, the investigators will be interested in whether or not it could be attributed to improved control of the underlying mental health condition, or, alternatively, whether it represents a direct effect of suicide-related behavior. VA NCT01928446
CSP 593 Metabolic Syndrome WH, WRJ In planning VA N/A
Benefits Counseling Remotely-delivered Benefits Counseling for Service-Connection Applicants CWM In planning VA N/A (2015-I01RX001319-01A2 )
Maternity Care Patterns and Experiences of Maternity Care Coordination for Women Veterans CWM, WH, BOS To examine prevailing approaches for pregnancy and maternity care delivery, including barriers and facilitators to maternity care coordination for pregnant Veterans in VA care. (In planning) VA N/A (HSR&D IIR13-81)