There are an estimated 15.4 million Americans diagnosed with heart disease. Clinicians often prescribe aspirin to prevent strokes and heart attacks in people living with heart disease, but research has yet to determine the best dose to use, since aspirin can cause serious side effects in some people.
To find the answers, the Patient-Centered Outcomes Research Institute (PCORI) http://pcori.org recently announced a three year $14 million clinical trial to compare the benefits and risks for side effects of the two commonly used doses of aspirin (325mg or 81mg) in preventing heart attacks and strokes in people with heart disease.
This is the first study to be conducted through the national Patient-Centered Clinical Research Network (PCORnet) www.pcornet.org. The Network is a collection of individual clinical research networks ready to harness the power of data to conduct research to answer important healthcare questions.
This study called “Aspirin dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness” (ADAPTABLE) is going to enroll and follow as many as 20,000 patients with heart disease using PCORnet’s resources.
The trial will be led by researchers at Duke University and will involve researchers, clinicians, and seven PCORnet partner networks. Eight of the networks are Clinical Data Research Networks (CDRN) based in large health systems and one is a Patient-Powered Research Network (PPRN) operated by a patient-led group.
What makes this study different is that researches will look at not only benefits and side effects but also look at participants by gender, age, ethnicity, and race. They will also look at patients with medical conditions in addition to heart disease, such as diabetes.
Patient leaders, study investigators, and operations and research staff met late October 2016 to discuss ideas and strategies on how to make this novel study a success. Russell Rothman, MD ADAPTABLE Study Co-Chair said, “This study represents an opportunity to revolutionize clinical research by leveraging health information technology that will lead to rapid participant identification, contact, consent, and data collection.”
Robert Harrington MD, ADAPTABLE Study Co-Chair said, “Traditional trials are expensive, long, and often don’t provide critical evidence. With costs typically at hundreds of millions and sometimes take more than five years to obtain results, the traditional model of research is not sustainable.”
The question asked, “Why can’t the pharmaceutical industry find an answer to the aspirin dose question?” According to Adrian Hernandez, MD ADAPTABLE Study Co-PI and PCORnet Co-PI, “It’s too expensive and would take too long for a company from the pharmaceutical industry to answer this question.”
However today with the power of PCORnet able to harness massive amounts of health data, the study will be able to clarify how much aspirin each patient should take after the study is completed.