Trial funded by Patient-Centered Outcomes Research Institute aims to compare the benefits and risks for two commonly used doses of aspirin in people with heart disease
INDIANAPOLIS – November 8, 2017 – Anthem Inc. is committed to playing an active role in identifying best approaches to health and care management. As part of that belief, Anthem’s outcomes research subsidiary, HealthCore Inc., will begin reaching out to select members of Anthem affiliated health plans regarding an opportunity to participate in an innovative research study on heart disease. The study is currently underway to help determine the most effective and safest dose of aspirin to prevent heart attacks and strokes, and Anthem’s affiliated health plans are expected to play a significant role in recruitment.
This landmark study, called ADAPTABLE, involves more than 30 leading health and medical organizations across the U.S. with a goal of enrolling 15,000 participants. The study, which is funded by the Patient-Centered Outcomes Research Institute (PCORI), will compare regular strength aspirin (325mg) to “baby” aspirin (81mg) among people with heart disease to help determine the best dose to use. While aspirin is widely prescribed to prevent strokes and heart attacks in people living with heart disease, the right dose is not established. This is because one dose may be better at preventing heart attacks while another may prevent serious side effects, such as bleeding.
Heart disease causes one in four deaths in the U.S., making it the country’s leading killer, and heart disease places enormous burdens on patients and their families as well as the U.S. healthcare system. While the ADAPTABLE trial is important on its own, it’s also the first study to be conducted through PCORnet, the National Patient-Centered Clinical Research Network. This innovative PCORI initiative is designed to empower people to make informed healthcare decisions by enabling clinical research that is faster, easier, less costly and, most importantly — more relevant to their needs.
“HealthCore and Anthem are excited to be taking part in this important trial, which is expected to yield practical, real-world guidance for the more than 15.4 million Americans living with heart disease,” said Mark Cziraky, HealthCore Executive Vice President and ADAPTABLE site primary investigator. “We’re taking the outreach for this trial to members who live across the country and many are in rural or other geographies that aren’t reached by traditional clinical trials.”
The ADAPTABLE study is one of several real-world comparative effectiveness research projects HealthCore is working on as part of a funding award received last year from PCORI.
“We hope that what we learn from ADAPTABLE will improve the care and outcomes for patients with heart disease,” said Adrian Hernandez, MD, MHS, ADAPTABLE Co-Principal Investigator. “But we are also excited by the prospect that this study will be a pragmatic model of leveraging data from multiple sources to help answer many other health questions that patients and their doctors face every day.”
Anthem plan-contracted physicians should receive letters within the next few weeks, advising them that Anthem will be sending information about this study to members who meet the study criteria. The letters will advise the selected Commercial, Medicare Advantage and Medicare Supplemental members to consult their doctor with any questions related to their ability to participate, as their enrollment may randomize them to a new aspirin dose.
Researchers will follow each participant for 30 months and look at the overall benefits and side effects of the various aspirin doses by gender, age, ethnicity and race as well as in patients with medical conditions in addition to heart disease, such as diabetes. The data will be collected electronically, reducing the burden on participants who won’t need to return to the clinic for numerous study visits. More information on the ADAPTABLE study can be found at theaspirinstudy.org.
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org.
About HealthCore, Inc.
HealthCore Inc., www.healthcore.com, uses real world data, including claims information, to provide clinical and other scientific expertise and research services to the pharmaceutical, biotechnology and device industries, in the conduct of industry-sponsored safety, health economic outcomes, comparative effectiveness, epidemiological and late stage research projects. HealthCore’s capabilities include retrospective database design and analysis, prospective observational research design and analysis, safety and epidemiologic research services, post authorization safety study (PASS), health services research, patient and/or provider survey development and implementation, and general research consultation.
About Anthem, Inc.
Anthem is working to transform health care with trusted and caring solutions. Our health plan companies deliver quality products and services that give their members access to the care they need. With over 73 million people served by its affiliated companies, including more than 40 million within its family of health plans, Anthem is one of the nation’s leading health benefits companies. For more information about Anthem’s family of companies, please visit www.antheminc.com/companies.