Through ADAPTABLE, the LaCDRN will be able to demonstrate its strength in recruiting trial participants and delivering faster results that work to optimize patient care and health outcomes.
New Orleans, LA (PRWEB) May 18, 2015
A three year, $14 million, national clinical trial designed to determine the best dose of aspirin to prevent heart attacks and strokes in people with heart disease will be offered to Louisiana and Texas residents by the Louisiana Clinical Data Research Network (LaCDRN).
The study called ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness), will compare the benefits and harms of a low- and regular-strength daily dose of aspirin in patients diagnosed with heart disease. The LaCDRN will implement ADAPTABLE at four institutions including Ochsner Health System, Tulane University Medical Center, Baylor Scott & White Health, Interim Louisiana State University Hospital and Healthcare Network. The LaCDRN has identified more than 100,000 eligible patients across the participating health systems to take part in the trial, which is funded by the Patient-Centered Outcomes Research Institute (PCORI).
“We are extremely excited to be a part of such an important study that’s focused on making sure patients with heart disease receive the best care,” said Thomas Carton, MS, PhD, Director of Health Services Research at the Louisiana Public Health Institute and the LaCDRN’s principal investigator. “Through ADAPTABLE, the LaCDRN will be able to demonstrate its strength in recruiting trial participants and delivering faster results that work to optimize patient care and health outcomes.”
“The ADAPTABLE trial is a prime opportunity for the LaCRDN and our partners to contribute to a nationwide study that is dedicated to heart disease, the leading cause of death for men and women in the country,” said Richard Re, MD, FACP, Scientific Director of the Ochsner Health System and the LaCDRN’s ADAPAPTABLE trial co-principal investigator. “Approximately 10,000 Louisianans die annually due to heart disease and stroke, so this study and its results could have a great impact on prolonging the lives of thousands of our residents.”
An estimated 15.4 million Americans have coronary heart disease, most of whom take either a regular-strength (325 mg) or a low-dose (81 mg) aspirin daily as recommended by their physicians. However, there is conflicting evidence about the potential benefits and risks of different doses. Regular-strength aspirin has been associated with a greater risk of bleeding in the gastrointestinal tract, but it's unclear whether low-dose aspirin is both safer and as effective for preventing heart attacks in patients with heart disease.
"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 LaCDRN is one of six health system-based data networks nationwide that will conduct ADAPTABLE, the first of several demonstration projects designed to test the capacity of PCORnet, the National Patient-Centered Clinical Research Network, to conduct comparative effectiveness and other types of research. PCORI invested $93.5 million in December 2013 to support the development and expansion of 29 individual health data networks that make up PCORnet. These include 11 CDRNs, based in large health systems, and 18 Patient-Powered Research Networks (PPRNs), based in a range of patient groups.
ADAPTABLE is a pragmatic trial designed to ensure that its results reflect "real world" medical practice. Instead of being conducted in specialized research centers under optimized conditions, it will be conducted among a broad patient population across a range of healthcare systems and practices. The study, which will be recruiting 20,000 participants nationwide, is intended to give patients and physicians evidence to inform decisions about aspirin therapy based on patients' personal characteristics, health conditions and preferences. Researchers will also 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.
For more information about the national study, click here.
The Louisiana Clinical Data Research Network (LaCDRN) is a partnership between the Louisiana Public Health Institute, Partnership for Achieving Total Health (PATH), Louisiana State University, Pennington Biomedical Research Center, Ochsner Health System, Tulane University and Baylor Scott & White Health. Awarded $6.9 M by the Patient Centered Outcomes Research Institution (PCORI), this collaborative partnership will increase the capacity to conduct robust comparative effectiveness research by building a health information technology infrastructure that provides access to comprehensive clinical data for more than one million patients in Louisiana.
Founded in 1997, The Louisiana Public Health Institute’s (LPHI) mission is to promote and improve the health and quality of life in Louisiana through public-private partnering at the community, parish and state levels. By fostering collaborative endeavors in the areas of health information, public policy, applied research, and community capacity enhancement, LPHI works to develop community-oriented solutions that improve the health of the Louisiana population. For more information, visit http://www.lphi.org.
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 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 http://www.pcori.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 comparative clinical 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 http://www.pcornet.org.