Novel New Study Could Finally Hold Answers to Questions about Aspirin Dosing

In Focus | While aspirin is widely used to prevent heart attacks and strokes in people with cardiovascular disease, research has yet to definitively determine the dose that works best while minimizing potentially serious side effects like internal bleeding. A new, large-scale pragmatic clinical trial conducted through PCORnet, an initiative of the Patient-Centered Outcomes Research Institute (PCORI), has the potential to put an end to these questions once and for all.

ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness), which is expected to begin enrolling patients this spring, will compare benefits and risks of two commonly used daily doses of aspirin—low-dose 81 mg and regular strength 325 mg—in as many as 20,000 patients with cardiovascular disease. Patients will be enrolled over 24 months with a maximum follow-up of 30 months and randomized to receive one of the two doses.  Researchers also will compare the effects of aspirin in certain patient populations based on gender, age, and racial- and ethnic-minority affiliation and in patients with and without diabetes or chronic kidney disease.

What makes ADAPTABLE unique is that it will leverage PCORNet’s networks of electronic health records (EHRs) to more quickly identify, enroll and follow a broad population and range of patients in a variety of clinical settings ranging from large health care systems to smaller practices. The trial will be led by researchers at Duke University and involve researchers, clinicians and patients at 7 PCORnet partner networks, 6 of which are based in large health systems, and 1 operated by a patient-led group.

In addition, the trial is expected to cost much less than a more conventional trial and be far more efficient.  For example, researchers will have direct access to clinical data vs. needing to re-enter data into a parallel research database. “We are striving to answer an important clinical question that interests both patients and providers in a highly efficient way that takes advantage of data that is already being collected as part of routine care,” says Robert A. Harrington, MD, co-chair of ADAPTABLE. “It’s truly better integrating research into clinical practice and helping in the construct of the learning health care system.”

Another highlight of ADAPTABLE is that it includes patient involvement every step of the way.  According to Matthew Roe, MD, MHS, FACC, co-principal investigator for the trial, the trial includes targeted electronic outreach and electronic follow-up with patients in order to ultimately provide answers to questions like ‘How much aspirin should be taken each day to reduce risks of heart attack or stroke’ and/or ‘Do benefits and risks differ based on dose, health, age or other circumstance’?  Patient engagement is a key and defining aspect of this trial.

“We’re excited to be part of the first trial conducted through PCORnet which is a national research network that unites patients, clinicians, health systems and electronic health records to improve patient-centered outcomes,” said Adrian F. Hernandez, MD, MHS, FACC, director of outcomes and health services research at the Duke Clinical Research Institute and PCORnet’s Coordinating Center Principal Investigator. “Heart disease is the leading cause of death for men and women in the United States. The results of this study will help patients and those who care for them make better decisions about how aspirin therapy might be most helpful and ultimately could prevent as many as 88,000 death per year worldwide.”

Keywords: CardioSource WorldNews, Aspirin, Myocardial Infarction, Stroke, Patient Outcome Assessment

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