August 20, 2015
Innovative study will determine best dose for heart disease care
Approximately 15 million Americans with heart disease take a daily dose of aspirin to help ward off heart attack and stroke, but it's not clear how much is best – regular strength 325mg or the 81mg "baby aspirin."
A nationwide study intends to find out, with researchers and caregivers at the University of Kansas Medical Center expected to play a significant role in the work.
Announced in May, the three-year trial will enroll about 20,000 patients at healthcare systems around the country. Some will take the regular dose, others the low dose. Results, including aspirin's potential to cause intestinal bleeding, will be collected and analyzed.
In addition to its sheer size and practical applications, the trial will emphasize innovation and efficiency, using new databases to enroll patients and analyze results.
"This is a unique study," said cardiologist Kamal Gupta, MD, who is leading the effort at the medical center. "If it is done right, it will be one of the most economical studies done on such a large number of patients."
The University of Kansas Medical Center is headquarters for the Greater Plains Collaborative, a network of 10 medical centers in seven states that are expected to participate in the study. Data analysts here plan to help researchers access electronic medical records across the network, allowing for quicker patient recruitment and other system efficiencies.
Also, the $14 million study, funded by the Patient-Centered Outcomes Research Institute (PCORI), is the first to use the national PCORnet data network. It will integrate findings from dozens of research sites, in addition to those in the Great Plains Collaborative.
Without the new data networks, Gupta said, the cost of such a large trial would likely cost at least $50-$60 million.
Because aspirin is reasonably priced and widely available, the study could have big implications for better health around the globe. The study's leaders hope results will help prevent 88,000 deaths per year worldwide by preventing heart attacks and reducing intestinal bleeding incidents.
"This will lay to rest the question of 81mg doses vs. 325mg doses," Gupta said. "It will be an important piece of information for cardiologists. But more importantly, it will be a proof-of-concept for this type of study design."