Tampa, FL (Dec. 12, 2014) – The USF Health Morsani College of Medicine is conducting a clinical trial comparing the effectiveness of a new rapid-onset anticoagulant medication known as Apixaban with the standard anticoagulant drug warfarin in stroke patients with atrial fibrillation, the most common type of abnormal heart rhythm.
The investigator-initiated study is part of a $2.2 million research award from Bristol Myers Squibb awarded to Arthur Labovitz, MD, professor and chair of the Department of Cardiovascular Sciences for the USF Health Morsani College of Medicine and director of Non-Invasive Cardiology at Tampa General Hospital.
USF Health cardiologist Dr. Arthur Labovitz, principal investigator for the AREST study.
Dr. Labovitz is the principal investigator for the study, which is called “Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation,” or AREST. The study is the part of the USF Health Heart Institute, which is co-directed by Dr. Labovitz.
Anticoagulant therapy lowers the risk of strokes caused by embolisms (blood clots) in patients with atrial fibrillation, but its use is associated with potentially deadly bleeding. The new randomized trial will evaluate whether early treatment with Apixaban, an alternative requiring less monitoring and re-dosing than warfarin, can prevent recurrent strokes and reduce the risk of brain bleeding in patients who have suffered a first embolic stroke.
“Current guidelines suggest delaying treatment for patients with atrial fibrillation who have had a stroke, often times for two weeks or more,” Dr. Labovitz said. “This commonly results in poor outcomes in these individuals. The AREST study will more aggressively treat these patients earlier, sometimes within 24 hours of symptoms, in order to improve their outcomes. The protocol tests the hypothesis that one of the newer blood thinners, Apixaban (Eliquis), will be safe and effective in this regard.”
Early research showing that the risk of intracranial bleeding is markedly reduced (50 percent) with the new oral anticoagulant prompted him for initiate and develop the AREST study, Dr. Labovitz said.
In the USF AREST study, researchers will give either warfarin or Apixaban to 120 adult patients admitted to Tampa General Hospital with a transient ischemic attack (TIA) or small to medium ischemic stroke, who also have a history of, or current diagnosis of, atrial fibrillation. Atrial fibrillation is a common cause of stroke.
Patients will be randomly given the medications within 48 hours of stroke symptom onset and then followed for 180 days to compare the incidence of recurrent stroke, death or intracranial hemorrhage.
USF Health’s Dr. Scott Burgin directs the TGH Comprehensive Stroke Center and is a co-investigator for the AREST study.
“This study could answer a question that has long been undefined, and that is the optimal timing for giving anticoagulant medication after having an acute stroke,” said W. Scott Burgin, MD, professor of neurology and chief of the USF Cerebrovascular Division in the USF Health Morsani College of Medicine, director of the HFAP Certified Comprehensive Stroke Center at Tampa General Hospital, and a co-investigator for the AREST study.
“This new anticoagulant medication is already showing a greater effectiveness and a higher safety profile so starting the medication sooner than the standard 14 days could improve outcomes for stroke patients.”
Dr. Labovitz (left) and co-investigator Dr. David Rose stand in the heart of the Neurosciences Intensive Care Unit at TGH. The researchers will track stroke patients taking the new anticoagulant for the AREST study.
Co-Investigators for the USF AREST study, who are all USF Health faculty, are Dr. Burgin; David Rose, MD, assistant professor of Neurology and medical director, Neuro-ICU at TGH; Sanders Chae, MD, JD, assistant professor of cardiology; Michael Fradley, MD, assistant professor of cardiology; Theresa Beckie, PhD, professor in the USF Health Morsani College of Medicine and the USF College of Nursing; Waldo R. Guerrero, MD, assistant professor of vascular neurology; and Ryan Martin, MD, a fellow in the USF Department of Cardiovascular Sciences.
For more information about the AREST clinical trial at USF Health, please contact Bonnie Kirby, MSN, RN, research administrator for USF Cardiovascular Sciences, at bkirby@health.usf.edu or call (813) 259-8543.
About USF Health
USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a Top 50 research university in total research expenditures among both public and private institutions nationwide, according to the National Science Foundation. For more information, visit www.health.usf.edu
