The Vanderbilt-based Mid-South Clinical Data Research Network (CDRN) is among seven CDRNs that will collaboratively mount a three-year, $14 million randomized clinical trial to determine the best daily dose of aspirin for preventing heart attacks and strokes among people living with heart disease.
This will be the first randomized comparative effectiveness trial conducted by PCORnet, also known as the National Patient-Centered Clinical Research Network. The trial is funded by PCORnet’s parent agency, PCORI, the Patient-Centered Outcomes Research Institute.
According to the announcement from PCORI, most of the 15.4 million Americans with heart disease take either a regular strength aspirin or a low-dose aspirin each day as recommended by their clinicians, and while regular strength aspirin has been associated with a greater risk of gastrointestinal bleeding, there is insufficient evidence to determine whether low-dose aspirin is safer and as effective for patients with heart disease.
The trial will randomly assign 20,000 patients with heart disease to one or the other of these two aspirin-taking groups. A Duke University team will lead the trial.
The co-principal investigators for Mid-South CDRN’s part of the trial are Sunil Kripalani, M.D., M.Sc., associate professor of Medicine, and Daniel Munoz, M.D., MPA, instructor of Medicine. Russell Rothman, M.D., MPP, professor of Medicine, Pediatrics and Health Policy, is principal investigator of the Mid-South CDRN, which is one of 29 PCORnet health data networks.
