ADAPTABLE study asks patients with heart disease, what is the right dose?

September 15, 2015 – The U.S. Preventative Services Task Force recently released a draft recommendation statement regarding aspirin use for heart health, the subject of ADAPTABLE. 

The U.S. Preventative Services Task Force recently released a draft recommendation statement stating that men and women ages 50 to 59 with a 10 percent or greater 10-year cardiovascular disease (CVD) risk, who are not at an increased risk for bleeding, should take low-dose aspirin for the primary prevention of CVD.  People who have no previous history of heart disease but are considered to be at risk should follow a low-dose aspirin regimen. (To see if you fall into this category, check out the NIH risk assessment tool.)

Adrian HernandezDiscussion and debate about disease management is vital to prevention and, ultimately, to population health. But what about patients with a prior history of heart disease? How should they prevent having another heart attack? And for aspirin what’s the right dose?

Today, more than 15 million Americans have coronary artery disease.  Current practice shows marked variation in the dosing used for aspirin ranging from 75 to 325 mg once daily for patients with a history of heart attack. This highlights that the optimal dose of aspirin for these patients—one that will provide the best balance between maximizing cardiovascular protection while minimizing the risk of bleeding—remains unclear.

These questions and more are to be addressed in The Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) study—the first demonstration project to be conducted through PCORnet, the National Patient-Centered Clinical Research Network. In the ADAPTABLE Study, 20,000 patients who are at high risk for ischemic events will be randomly assigned in a 1:1 ratio to receive an aspirin dose of either 81 mg per day or 325 mg per day. For up to 30 months, researchers will conduct follow-up centrally via a patient web portal or by telephone and by PCORnet’s data platform.

“ADAPTABLE involves several PCORnet partner networks that will compare the effect of two different aspirin doses given to prevent heart attacks and strokes in high-risk patients with a history of heart disease,” said Adrian Hernandez, MD, MHS, director, Health Services and Outcomes Research and co-principal investigator for the study (pictured left). “It’s a different kind of study for an evolving era of clinical research. We’re publicly requesting advice and feedback on key aspects of the study from patients, physicians, and research communities and therefore ushering in a new research paradigm defined by unprecedented transparency.”

“Approaches to patient-centered clinical research like those being applied in ADAPTABLE matthew-roe-news2enable patients to inform researchers about what matters most to them and their families,” said Matthew Roe, MD, MHS, FACC, director of the DCRI’s Global Outcomes Commercial MegaTrials group and co-principal investigator for the study (pictured right). “In turn, researchers can design trials that focus on the clinical outcomes most meaningful to patients. Study designs tailored to reflect patient values build trust throughout the entire research enterprise.”

ADAPTABLE, which is based on a model of sharing knowledge, provides a unique opportunity for collaboration among physicians, patients, patient representatives, investigators, research study team members, and support staff.

To learn more about the ADAPTABLE Aspirin Study, visit: www.pcornet.org/aspirin. And to learn more about the USPSTF draft recommendation, click here.