Thomas Ortel, MD, PhD, professor of medicine and pathology, chief of the Division of Hematology and medical director of the Clinical Coagulation Laboratory, has received a funding award from the Patient-Centered Outcomes Research Institute (PCORI).
Dr. Ortel will receive $15 million over five years for the project "Warfarin versus Direct Oral Anticoagulants for Secondary Prevention of Recurrent Venous Thromboembolism: A Randomized Comparative Effectiveness Trial."
The project will compare three anticoagulants in patients with a deep vein thrombosis or pulmonary embolism who need to take anticoagulant therapy long-term: warfarin (Coumadin), rivaroxaban (Xarelto), and apixaban (Eliquis).
Warfarin has been around the longest, and requires having regular blood checks to make sure it is in the right range. Rivaroxaban and apixaban are newer and do not require any laboratory testing. Warfarin also interacts with many foods, which is not a problem with rivaroxaban and apixaban.
The research study will determine whether the new medications are as good as warfarin and whether they have fewer problems with bleeding complications, which can occur with any anticoagulant.
“Our study will be the first to compare the safety and efficacy of rivaroxaban and apixaban, two direct oral anticoagulants that target factor Xa, to warfarin for patients who remain on indefinite anticoagulation following an initial, unprovoked venous thromboembolism," Ortel said. "A unique component of this proposal is the engagement of patients and key stakeholders, and the inclusion of patient partners in the conduct of the study.”
The study was selected for funding through a PCORI funding announcement specifically focused on the use of new oral anticoagulants (NOACs) in the extended treatment of venous thromboembolic disease. Input from and discussion with a variety of stakeholders identified this research gap and narrowed the topic to the extended use of anticoagulation treatment for patients who have completed of a course of treatment after an initial episode of deep vein thrombosis (DVT) or pulmonary embolism (PE).
“There have been no studies comparing the newer oral blood thinning drugs for extended treatment of blood clots in veins and lungs. This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other stakeholders, but also for its potential to fill an important gap in our health knowledge,” said PCORI Executive Director Joe Selby, MD, MPH. “We look forward to following the study’s progress and working with Duke University to share the results.”
Ortel's award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
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.