PCORI approves trial to determine best aspirin dose to help heart disease patients

The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors this week approved a 3-year, $14 million clinical trial designed to determine the best dose of aspirin to use to prevent heart attacks and strokes in people with heart disease.

The study, called ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness), will compare the benefits and harms of a low- and regular-strength daily dose of aspirin in patients diagnosed with heart disease.

“Aspirin has been used for more than 40 years to prevent heart attacks and strokes in people diagnosed with heart disease, but the best dose has yet to be determined,” said PCORI Executive Director Joe Selby, MD, MPH. “We know aspirin can help, but we also know it can cause serious side effects, such as increased bleeding. So we’re very pleased to fund a study designed to answer this question.”

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An estimated 15.4 million Americans have coronary heart disease, most of whom take either a regular-strength (325 mg) or a low-dose (81 mg, or “baby aspirin”) dose daily as recommended by their clinicians. However, there is conflicting evidence about the potential benefits and risks of different doses, PCORI noted. Regular-strength aspirin has been associated with a greater risk of bleeding in the gastrointestinal tract, but it’s unclear whether low-dose aspirin is both safer and as effective for patients with heart disease.

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ADAPTABLE is the first demonstration project to be conducted through PCORnet, the National Patient-Centered Clinical Research Network, which PCORI is developing to enhance the nation’s capacity to conduct much-needed health outcomes studies more quickly and efficiently, less expensively, and with greater potential impact than is now possible.

 “We’re excited to be part of the first trial conducted through PCORnet,” said Adrian F. Hernandez, MD, MHS, director of Outcomes and Health Services Research at the Duke Clinical Research Institute and the study’s co-principal investigator. “The results of this study, to be conducted in a variety of clinical settings, will help patients and those who care for them make better decisions about how aspirin therapy might be most helpful.”

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