$90 million award expected from the National Institute of Aging and the National Heart, Lung, & Blood Institute to fund largest pragmatic trial with placebo-controlled drug assignment to date
In the first statin trial with a non-cardiovascular primary outcome, investigators to study whether statins could help prevent dementia or physical disability
DURHAM, N.C., Oct. 23, 2019 /PRNewswire/ -- Building on its success in leading pragmatic approaches for clinical study design, the Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine, has been awarded funding to conduct a pragmatic trial studying the effectiveness of statins in older adults without known cardiovascular disease. Funding for the trial is expected to total $90 million over the next seven years.
The study, known as Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults (PREVENTABLE), will be funded by the National Institute of Aging and the National Heart, Lung, & Blood Institute of the National Institutes of Health under award number U19AG065188 and conducted in partnership with Wake Forest School of Medicine. The largest pragmatic trial with placebo-controlled drug assignment to date, PREVENTABLE also is the first statin trial with a non-cardiovascular primary outcome. Investigators will study whether statins could help prevent dementia or physical disability—the most important outcome for older adults looking to maintain independence.
PREVENTABLE will partner with PCORnet®, the National Patient-Centered Clinical Research Network, and the National VA Network to identify and recruit 20,000 participants 75 years of age or older at 100 U.S. sites, as well as to help identify outcomes via electronic health records. Utilization of these two national resources is expected to enable investigators to enroll participants and collect health data faster and more efficiently than a traditional trial.
Statins have been shown to effectively reduce the risk of cardiovascular events for both primary prevention populations and patients with known coronary artery disease, or secondary prevention. However, few statin studies in primary prevention populations have included individuals aged 75 or older, leaving many unanswered questions for older adults.
"Given that these older adults have survived without coronary artery disease for longer, this suggests these individuals may have a different risk profile," said the DCRI's Karen Alexander, MD, principal investigator for PREVENTABLE. "These patients are also more likely to be facing other health issues and taking a number of medicines on a daily basis. Interestingly, effective vascular prevention may be helpful in reducing the occurrence of other common conditions with aging such as cognitive impairment, functional decline, or heart failure. Therefore, it is important for us to clarify the effectiveness and benefit of statins for this population before adding one more medication to the list of medicines older adults are taking."
The DCRI will lead the clinical coordinating center for PREVENTABLE, and Wake Forest School of Medicine will lead the data coordinating center and geriatric assessments. Recruitment and retention will be performed by the Recruitment Innovation Center at Vanderbilt University, and the Biorepository will be located at the Mayo Clinic. To effectively engage an older population, PREVENTABLE will use pragmatic approaches throughout, including:
- Embedding research in the health care system by enrolling patients in their usual care settings and in partnership with their primary care clinicians;
- Engaging potential participants during screening and recruitment by using informational videos, panel discussions with research participants, and an e-consent platform;
- Pairing electronic health record data with other forms of follow-up, including calls and in-person visits for cognitive and functional assessments, to ensure complete collection of outcomes; and
- Simplifying study drug delivery by shipping directly to patients.
PREVENTABLE draws on the DCRI's expertise in leveraging PCORnet to design and conduct pragmatic clinical trials. In 2015, the launch of ADAPTABLE signaled the first DCRI-led trial to combine use of electronic health records and traditional methods for large-scale patient recruitment, successfully recruiting more than 15,000 participants. ADAPTABLE also embraced a new paradigm of patient and provider engagement in clinical research. PREVENTABLE will use learnings from ADAPTABLE and will involve its DCRI principal investigators, Adrian Hernandez, MD, MHS, and Schuyler Jones, MD.
About the Duke Clinical Research Institute
The DCRI, part of the Duke University School of Medicine, is the largest academic research organization in the world. Its mission is to develop and share knowledge that improves the care of patients through innovative clinical research. The institute conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding.