A study funded by the Patient-Centered Outcomes Research Institute (PCORI) will examine the most effective dose of aspirin to use in patients with heart disease.
PCORI announced on May 4 that the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness) trial will randomly assign 20,000 patients to receive daily aspirin doses of 81 mg or 325 mg. The inclusion criteria includes patients who have had a heart attack or significant blockage of their coronary arteries. PCORI granted $14 million to fund the study.
Lead researcher Matthew Roe, MD, of Duke University in Durham, N.C., and colleagues will enroll patients for up to 24 months and follow them for a maximum of 30 months.
They are interested in identifying the optimal aspirin dose to use as secondary prevention in atherosclerotic cardiovascular disease. They defined the optimal dose as the one associated with the lowest risk of ischemic and bleeding events. They will collect patient-reported outcomes and compare the two aspirin doses without having a placebo group.
Previous studies have indicated the 325 mg dose of aspirin was associated with a higher risk of gastrointestinal bleeding, although no studies have compared the safety and efficacy of the 81 mg and 325 mg doses.
PCORI was created in 2010 as part of the Patient Protection and Affordable Care Act. The ADAPTABLE study will be the first to incorporate PCORNet, an initiative that created a national network of clinical outcomes research.