CAPriCORN to Help Determine Best Aspirin Dose to Protect Patients with Heart Disease

CAPriCORN to Help Determine Best Aspirin Dose to Protect Patients with Heart Disease

First PCORnet Demonstration Study Could Help Guide Treatment Options for Millions

May 4, 2015 – CAPriCORN will play a key role in a new $14 million research study announced today by the Patient-Centered Outcomes Research Institute (PCORI) to determine the best daily dose of aspirin to use in preventing heart attacks and strokes among people living with heart disease. CAPriCORN is one of six health system-based data networks that will conduct the three-year clinical trial funded by PCORI.

The study, approved today for funding by PCORI’s Board of Governors, is called ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness) and will compare the benefits and harms associated with different doses of aspirin taken daily. Most of the 15.4 million Americans with heart disease take either a regular strength aspirin (325 mg) or a low-dose aspirin (81 mg) each day as recommended by their clinicians.

However, there is conflicting evidence about the potential benefits and risks of these different doses. Regular strength aspirin has been associated with a greater risk of gastrointestinal bleeding. At the same time, there is insufficient evidence to clearly state whether low-dose aspirin is both safer and as effective for patients with heart disease.

The trial is the first demonstration project to be conducted through PCORnet, the National Patient-Centered Clinical Research Network, which PCORI is developing to enhance the nation’s capacity to conduct much-needed health outcomes studies more quickly and efficiently, less expensively, and with greater potential impact than is now possible. CAPriCORN is one of the 29 health data networks participating in PCORnet with PCORI funding support.

“Aspirin has been used for more than 40 years to prevent heart attacks and strokes in people diagnosed with heart disease, but the best dose has yet to be determined,” said PCORI Executive Director Joe Selby, MD, MPH. “We know aspirin can help, but we also know it can cause serious side effects, such as increased bleeding. So we’re very pleased to fund a study designed to answer this question. We’re especially pleased to do so as a way to demonstrate the power of PCORnet to recruit trial participants more efficiently and potentially generate results faster than would be possible otherwise.”

The trial will randomly assign a total of 20,000 patients who have had a heart attack or have significant blockage of their coronary arteries to use a daily aspirin dose of either 81 mg or 325 mg. Patients will be enrolled over 24 months, with a maximum follow-up of 30 months.

The study is designed to provide patients and providers with detailed information about aspirin therapy given patients’ personal characteristics, conditions, and preferences. 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.

ADAPTABLE is a pragmatic trial, designed to ensure that its results reflect “real-world” medical practice. Instead of being performed in specialized research centers under optimized conditions, it will be conducted in a variety of clinical settings among a broad population and range of patients, healthcare systems, and practices. This is possible because the trial will use PCORnet’s vast “network of networks,” each of which engages a variety of patients, providers, and health systems working together to harness the power of health data for clinical research.

To facilitate more-efficient recruitment, the trial aims to enroll patients via a unique patient-friendly web portal (Health eHeart) and use a patient-friendly electronic informed consent and information process. Paper-based consent material will also be available as needed.

ADAPTABLE will be the first of several demonstration projects designed to test PCORnet’s capacity to conduct comparative effectiveness and other types of research. PCORI invested $93.5 million in December 2013 to support the development and expansion of the 29 individual health data networks that make up PCORnet. These include 11 Clinical Data Research Networks (CDRNs), based in large health systems, and 18 Patient-Powered Research Networks (PPRNs), based in a range of patient groups. PCORI plans to offer up to an additional $150.7 million to support further development of PCORnet.

The award to support the aspirin trial was approved by PCORI’s Board pending completion of a business programmatic review by PCORI staff and issuance of a formal award contract.

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About CAPriCORN

The Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN) is an unprecedented collaboration with a mission to develop, test, and implement strategies to impact health care quality, health outcomes, and health equity for diverse residents in the metropolitan Chicago region and the nation. Within the Chicago metropolitan area, CAPriCORN seeks to address the needs of an estimated 9.5 million residents, including groups that experience significant health inequities partly due to variable access to high-quality care. Nationally, as a Clinical Data Research Network (CDRN), CAPriCORN is able to contribute data and expertise to strengthen the capacity of PCORnet to engage in sustainable, population-wide, and patient-centered outcomes research.

About PCORI

The Patient-Centered Outcomes Research Institute (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 the better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

About PCORnet

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 comparative effectiveness research efficiently by creating a large, highly

representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research. More information is available at www.pcornet.org