Assessing whether low- or high-dose aspirin is better for patients with coronary artery disease will be the focus of the first clinical trial to be conducted through PCORnet, the National Patient-Centered Clinical Research Network.
The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors approved the trial topic and up to $10 million to fund the study.
Many of the roughly 15.4 million Americans who have coronary artery disease take aspirin daily as a preventive strategy. More than half of these patients take a higher dose than the 81 milligrams currently recommended by federal government guidelines. High doses of aspirin are associated with a greater risk of intestinal bleeding, but there is insufficient evidence to clearly state whether low-dose aspirin is both safer and as effective for patients with this heart condition.
The randomized controlled trial will be conducted by researchers involved in the health data networks that together comprise PCORnet, a national health data research infrastructure being developed with PCORI funding. The trial will serve as a test run of PCORnets capabilities and efficiency, in addition to providing evidence to help patients with coronary artery disease and those who care for them make better-informed decisions about an important treatment option.
PCORI said the 29 individual research networks comprising PCORnet will collaborate to harness health information gathered from sources such as electronic health records, claims, and patients themselves to power more efficient and faster patient-centered health research.
A protocol review committee will be appointed that will help to develop the trial design and advise the institute during the conduct of the study. PCORI will issue a limited request for proposals in late 2014 to PCORnet partners and expects to issue funding awards to the team that will conduct the trial in spring 2015. The trial is expected to last no more than 18 months.
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