As we continue to expand our portfolio and bring on new trials/projects, other projects are coming to an end. Many of these projects publish their findings or are recognized for their research at conventions etc.
Below are some of the projects that were funded through the foundation and have now closed and no longer collection / analyzing new data.
Title: A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19
About: This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.
Principal Investigator: Dr. Kaharu Sumino
Funded By: This study was administered by VREF and funded by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and carried out by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT).
Title: Apixaban for the Reduction of Thromo-Embolism in Patients with Device-Detected Sub-Clinical Atrial Fibrillation
About: The main purpose of the ARTESiA study, is to determine if the use of apixaban in patients with sub-clinical atrial fibrillation (SCAF) will reduce the incidence of stroke and systemic embolism compared to aspirin.
Principal Investigator: Dr. Molly Sachdev
Study Coordinator: Linda Schimmoeller
Funded By: This study was administered by VREF and funded by PHRI.
Title: A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography BC of Suspected Coronary Artery Disease
About: This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.
Principal Investigator: Dr. Medhat Osman
Funded By: This study was administered by VREF and funded by GE Healthcare
Title: Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia (BEST-CLI)
About: This study compares the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.
This study is currently closed to recruitment and data analysis has begun.
Principal Investigator: Dr. Mohamed Zayed
Study Coordinator: Kelley Chadwick-Mansker
Funded By: This study was administered by VREF and funded by Neuriscience.
About: The primary objective of the BEST-Registry is to enroll patients excluded from the BEST-CLI Trial and thereby assess real-world therapeutic strategies, clinical outcomes, and costs associated with critical limb ischemia. By enrolling patients excluded from the BEST-CLI trial, data from the BEST-Registry will also provide important context to the results of the BEST-CLI Trial.
Principal Investigator: Dr. Mohamed Zayed
Study Coordinator: Kelley Chadwick-Mansker
Funded By: This study was administered by VREF and funded by NHLBI (the National Heart Lung and Blood Institute).
Title: Prostate Cancer Patients With Biochemical Recurrence
About: Evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging techniques within 30 days of the standard of care imaging study and a 6 month phone follow-up. This study is currently closed to recruitment.
Principal Investigator: Dr. Medhat Osman
Funded By: This study was administered by VREF and funded by Blue Earth Diagnostics.
Title: PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis with 64Cu-25%-
About: The main objective of CANF-Comb is to demonstrate feasibility of imaging CANF-Comb uptake in the atherosclerosis of the carotid artery of patients for whom carotid artery endarterectomy surgery is planned in comparison to the carotid artery for which intervention is not planned.
CANF-COMB was a joint study with the St. Louis VA and Washington University. This study is now closed.
Principal Investigator: Dr. Mohamed Zayed
Study Coordinator: Molly Mohrman
Funded By: The Study was administered by VREF and funded by the NIH (National Institute of Health)
About: CANF-COMB II was a joint study with the St. Louis VA and Washington University.
Principal Investigator: Dr. Mohamed Zayed
Funded By: The Study was administered by VREF and funded by the NIH (National Institute of Health)
Title: A phase III, multicenter, randomized, double blind, placebo controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cmN2) completely resected (R0) non-small cell lung cancer (NSCLC)
About: The primary purpose of the study is to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II -IIIA and the subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC). This study is now closed.
Principal Investigator: Dr. Eric Knoche
Funded By: This study was administered by VREF and funded by Novartis.
Principal Investigator: Dr. Steven Weintraub
Title: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
About: Prevention of stroke involves managing and treating risk factors. Most strokes are caused when blood flow to a portion of the brain is blocked. One place this often happens is in the carotid artery. This blockage is called atherosclerosis or hardening of the arteries.
The purpose of this trial is to determine the best way to prevent strokes in people who have a high amount of blockage of their carotid artery but no stroke symptoms related to that blockage. Each eligible participant will be evaluated to determine which procedure(s) is best for him/her. All participants will receive intensive medical treatment. In addition, participants will be randomized to receive the selected procedure or not.
This study was a joint study with the St. Louis VA and the Mayo Clinic.
Principal Investigator: Dr. Emad Zakhary
Funded By: The study was administered by VREF and funded by NIH (National Institute of Health).
Title: Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts
About: This Multi-Center Clinical Trial is designed to evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES)
Our study team was recognized for being the #1 site in enrollment for this trial thanks to the amazing work done by the study team.
This study is now closed.
Principal Investigator: Dr. Nikhil Panda
Funded By: This study was administered by VREF and funded by Cardiovascular Systems Inc.
Title: Fluid management of Acute decompensated heart failure Subjects Treated with Reprieve Decongestion Management System (DMS) (FASTR)
About: The purpose of this study is to test a treatment approach for subjects with acute decompensated heart failure who come to the hospital or the emergency room and require treatment for their fluid volume overload and need to remove excess fluids. The Reprieve DMS is designed to provide an efficient method of safe and rapid fluid loss and to produce the desired urine output to relieve patients of their heart failure symptoms.
This study was a joint study with the St. Louis VA and Washington University in St. Louis.
Principal Investigator: Dr. Jonathan Moreno
Study Coordinators: Stephanie Stilinovic and Amen Zelleke
Funded By: The study was administered by VREF and funded by Reprieve Cardiovascular, Inc.
Title: Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
About: The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
These studies are now closed to enrollment and data analysis has begun.
Principal Investigator: Dr. Geetha Maddukuri
Study Coordinator: Linda Schimmoeller
Funded By: This study was administered by VREF and funded by Bayer.
Title: INtervention Study In overweiGHT patients with COPD
About: COPD is the 3rd leading cause of death in the U.S. which is due to cigarette smoking, often accompanied with unhealthy lifestyle habits that lead to physical limitation and weight gain. This study is about finding out if a lifestyle program will improve Chronic Obstructive Pulmonary Disease symptoms of patients with high body mass index.
The lifestyle program involves promoting healthy diet and increasing physical activity to hopefully lead to weight loss and better exercise tolerance. In addition, the effects on shortness of breath, quality of life, and cardiovascular disease risk factors are also being observed.
Principal Investigator: Dr. Kaharu Sumino
Study Coordinator: Marie White
Funded By: This study was administered by VREF and funded by NIH (National Institute of Health)
Title: INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
About: INVESTED is a randomized, double-blind, multicenter trial to assess the cardiopulmonary benefit of high dose comparted with standard dose influenza vaccine in a high-risk cardiovascular population. Potential subjects must have a history of Myocardial infarction in the previous 12 months OR history of heart failure hospitalization in the previous 24 months.
Subjects will be randomized in a 1:1 ratio to high dose or standard dose. Total trial duration is 5 years including site initiation, a Vanguard season followed by 3 influenza seasons, and follow up until the end of the last influenza recruiting season.
This study is now closed to enrollment and data analysis is completed. To view the results from this study go to clinicaltrails.gov
Principal Investigator: Dr. Geoffrey Gorse
Study Coordinator: Peggy Donovan
Funded By: This study was administered by VREF and funded by NIH (National Institute of Health).
Title: A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib Compared with Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)
About: The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label.
Principal Investigator: Dr. Theodore Thomas
Study Coordinator: Marie White
Funded By: This study was administered by VREF and funded by Merck Sharp & Dohme Corporation.
Principal Investigator: Dr. Nathan Ravi
Title: Impact of Adding Genomic Testing (Prolaris) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients with Long Term Follow-up Post-Treatment to Measure the Prediction of Progression/Recurrence in Men Treated in the VA
About: This is a prospective study to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. This study is now closed to enrollment.
Principal Investigator: Dr. Ralph Torrence
Study Coordinator: Kelley Chadwick-Mansker
Funded By: This study was administered by VREF and funded by Myriad Genetics.
Title: Phase III Study of Olaparib Plus Abiraterone Relative to Placebo plus Abiraterone as First Line Therapy in Men with Metastatic Castration-resistant Prostate Cancer
About: The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.
This study is now closed to enrollment.
Principal Investigator: Dr. Eric Knoche
Study Coordinator: Kelley Chadwick-Mansker
Funded By: This study was administered by VREF and funded by AstraZeneca
Title: An international Prospective, Open-label, Multi-Center, Randomized Phase III Study comparing lutetium (177LU) vipivotide tetraxetan (AAA617) versus observation to delay castration or disease recurrence in adult male patients with prostate-specific membrane antigen (PSMA) positive Oligometastatic Prostate Cancer (OMPC) (PSMA DC 2302)
- Principal Investigator: Dr. Medhat Osman
- Study Coordinators: Lindsey Vargo
This purpose of this study was to evaluate the efficacy of AAA617 versus observation after Stereotactic Body Radiation Therapy (SBRT), in delaying castration or disease recurrence in adult patients with PSMA positive OMPC with 1 to 5 metastatic lesions detected by PSMA PET using gallium (68Ga) gozetotide or piflufolastat (18F), negative for M1 disease by conventional imaging (CI).
This study is administered by VREF and funded through Novartis.
Title: REASSURE-Radium-223 alpha Emitter Agent in Safety Study in mCRPC population for a long-teRm Evaluation, a noninterventional, observational study
Principal Investigator: Dr. Medhat Osman
Funded By: This study was administered by VREF and funded by Bayer.
Principal Investigator: Dr. Mohamed Zayed
Title: A Phase3, Multi-center, Open-label Study to Test the Diagnostic Performance of Copper Cu64PSMAI & TPET/CT in Men with Biochemical Recurrence of Prostate Cancer (SOLAR 002)
About: SOLAR 002 is a prospective phase 3 study that focuses on determining the accuracy of copper Cu 64 PSMA I&T PET/CT in the diagnosis of biochemical recurrence of prostate cancer. This study is now closed to enrollment.
Principal Investigator: Dr. Medhat Osman
Study Coordinators: Lindsey Vargo and Dhruv Mitroo
Funded By: This study was administered by VREF and funded by CURIUM.
Title: A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk, or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection (SOLAR 003)
About: SOLAR 003 focuses on determining the safety and effectiveness of Copper Cu 64 PSMA I&T Injection as an imaging agent in the staging of men with newly diagnosed prostate cancer in those electing to undergo radical prostatectomy with extended pelvic lymph node dissection.
Principal Investigator: Dr. Medhat Osman
Study Coordinator: Lindsey Vargo
Funded By: This study was administered by VREF and funded by CURIUM.
Title: SPLASH: Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using 177Lu-PNT2002 PSMA Therapy After Second-line Hormonal Treatment
About: This is a phase I/II dose-escalation study of 225Ac-J591 administered together with 177Lu-PSMA-I&T (also known as PNT2002). The two study drugs are 225Ac-J591 and 177Lu-PSMA-I&T. Both drugs are designed to deliver radiation to prostate cancer cells; they are known as radionuclide conjugates (radiation linked to antibodies/molecules that recognize prostate cancer cells). The first phase of the study (phase I) will determine the highest dose of the study drug that can be safely given. The second phase of the study (phase II) will determine the effectiveness of the drug combination in patients with prostate cancer.
Principal Investigator: Dr. Medhat Osman
Study Coordinator: Janine Kampelmann
Funded By: This study was administered by VREF and funded by POINT Biopharma.
Title: Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
About: This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide. This study is now closed.
Principal Investigator: Dr. Eric Knoche
Study Coordinator: Linda Schimmoeller
Funded By: This study was administered by VREF and funded by Pfizer.
Title: A randomized phase III study using 177Lu-PSMA-617 as a radioligand therapy in the treatment of patients with progressive, PSMA positive, metastatic castration resistant prostate cancer.
About: The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.
Key secondary objectives are an arm-to-arm comparison of the following:
- Radiographic progression-free survival (rPFS)
- Response Evaluation Criteria in Solid Tumors (RECIST) response
- Time to a first symptomatic skeletal event (SSE)
This study is now closed to enrollment.
Principal Investigator: Dr. Medhat Osman
Funded By: This study was administered by VREF and funded byEndocyte.
Title: Pragmatic Trial of WHT vs. PC-GE to Promote Non-Pharmacological Strategies to Treat Chronic Pain in Veterans (wHOPE)
About: The overarching goal of this Pain Management Collaboratory Demonstration project is to test a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that is hypothesized to reduce pain symptoms and improve overall functioning and quality of life in Veterans.
This study is now closed.
Principal Investigator: Dr. Kavitha Reddy
Study Coordinator: Ray Gao
Funded By: This study was administered by VREF and funded by the National Center for Complementary and Integrative Health.
Title: Targeted intensive case management of Veterans at risk of suicide post inpatient hospitalization
- Principal Investigator: Dr. Jeffrey Benware
This pragmatic trial will evaluate the effects of a remote post-discharge intensive case management program (CLASP; Coping Long Term with Active Suicide Program) among psychiatric inpatients, identified as high risk of post-discharge suicide, in the Veterans Health Administration (VHA) healthcare system.
This study was administered by VREF and funded by the Warren Alpert Foundation.