Aspirin has been used for more than 40 years to prevent heart attacks and strokes in people with heart disease but, surprisingly, research has yet to determine the best dose to prescribe. For the millions of Americans with heart disease, doctors typically recommend either a regular-strength (325 mg) or a low-dose (81 mg) aspirin. But we still don’t know which dose is best for balancing aspirin’s benefits against its risks, such as bleeding in the gastrointestinal tract in some patients.
To answer that question, our Board of Governors has just approved a three-year, $14 million clinical trial comparing the benefits and harms of low-dose and regular-strength aspirin in preventing heart attacks and strokes in patients living with heart disease. This is important on its own but especially exciting because it’s the first study to be conducted through PCORnet, the National Patient-Centered Clinical Research Network. As such, it’s designed to demonstrate how harnessing the power of data through this developing national resource can quickly and efficiently provide answers to important health questions at lower cost than would be possible otherwise.
Targeting Results Useful to Individual Patients
The study, called ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness), will involve patients who have coronary artery disease, the most common form of heart disease. These patients are at high risk of having a heart attack or stroke, and many will have already suffered one or the other.
Designed to provide detailed information about aspirin therapy, the study will take into account patients’ personal characteristics, conditions, and preferences. As the researchers analyze the effects of the different aspirin strengths, they will consider gender, age, racial and ethnic group, and presence of diabetes or chronic kidney disease, rather than giving results only in terms of an “average” patient.
ADAPTABLE also is a “pragmatic” clinical trial. This means that instead of being conducted in specialized research centers under optimized conditions as many traditional trials are, it will take place in a range of clinical settings across a broad range of patients, healthcare systems, and practices. We take this approach to increase the usefulness of the results in real‐world medical practice. We’re also pleased that patients, clinicians, and other healthcare stakeholders are part of the research team and will help to design and conduct the study and be involved at every stage.
Including a Wide Range of Healthcare Systems
ADAPTABLE will be led by researchers at Duke University and include researchers, clinicians, and patients from seven PCORnet partner networks across the country. Six of them are Clinical Data Research Networks (CDRNs), based in large health systems, and one is a Patient-Powered Research Networks (PPRN), operated by a patient-led group. The trial will randomly assign 20,000 patients who have had a heart attack or have significant blockage of their coronary arteries to take a daily low-dose or regular-strength aspirin. Patients will be enrolled over 24 months, with up to 30 months of follow-up. All of the work will observe rigorous data security, privacy, and informed consent standards.
PCORnet Partner Networks Participating in ADAPTABLE
In addition this study, PCORI’s Board has approved topics for two more PCORnet demonstration projects. We’ll be announcing details in the coming months.
We hope that what we learn from the ADAPTABLE study will improve care and outcomes for patients with heart disease. But we’re also excited by the prospect that this study will be a major step forward in the effort, by PCORI and others, to leverage data to conduct the kind of research that can help us answer many other health and healthcare questions that patients—and their doctors—face every day.
Heart disease causes one in four deaths in the United States, more than 600,000 in 2013 alone, making it this country’s leading killer. This disease places enormous burdens not only on patients and their families, but on the nation and its healthcare system as a whole. That alone is reason enough to seek a clear answer to the question of how to best use a common drug to prevent heart attacks and strokes in these patients—and makes it a fitting tryout for PCORnet.
Please join me in congratulating everyone participating in this first PCORnet-powered study. We look forward to this trial as the first of many that will harness the power of data to answer questions important to patients and those who care for them.