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.
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.
"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."
Provided by University of South Florida
