A new clinical trial led by investigators at NewYork-Presbyterian, Columbia University Medical Center (CUMC) and Weill Cornell Medicine aims to identify and treat what may be a common underlying cause of recurrent strokes. ARCADIA, a multicenter phase III trial, will study the role of abnormalities in the structure and function of the heart’s left atrium, or atrial cardiopathy, in stroke patients, and test a medication that could prevent them from experiencing recurrent strokes.
A common heart rhythm disorder called atrial fibrillation is currently thought to be required for blood clots to form in the left atrium, which can, in turn, cause strokes. When atrial fibrillation is present, physicians administer blood-thinning drugs such as apixaban that are effective in preventing recurrent strokes.
However, as many as one-third of strokes are classified as “cryptogenic,” meaning they have no known origin. These patients are generally advised to take an aspirin daily. There is evidence that atrial cardiopathy can cause clots to travel to the brain in the same way as atrial fibrillation, and thus could be responsible for many of these cryptogenic strokes.
“We strongly suspect based on several studies we have performed that atrial cardiopathy may be a common cause of stroke among patients whose strokes are otherwise unexplained,” said Dr. Mitchell Elkind, attending neurologist on the Stroke Service at NewYork-Presbyterian/Columbia University Irving Medical Center, professor of neurology and epidemiology in the Gertrude H. Sergievsky Center at CUMC and one of the lead investigators of the trial. “This trial will provide us with important insight into whether atrial cardiopathy really is an important risk factor for stroke, and could also lead to an effective treatment for many patients.”
“As it stands now, many neurologists will only treat a stroke patient with apixaban if the patient has atrial fibrillation,” said Dr. Hooman Kamel, assistant attending neurologist at NewYork-Presbyterian/Weill Cornell Medical Center, associate professor of neurology and director of the Clinical and Translational Neuroscience Unit of the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine, and one of the lead investigators on the trial. “However, apixaban might also prevent clotting in patients with atrial cardiopathy. If apixaban can prevent recurrent strokes in these patients, it will have an immediate impact on how we think about stroke care going forward. Strokes are the leading cause of disability in the United States, and it’s important that we develop new treatments to prevent them.”
The trial, sponsored by the National Institute of Neurological Diseases and Stroke (NINDS), will recruit 1,100 patients who have experienced an ischemic stroke and have atrial cardiopathy at 120 sites in the NINDS StrokeNet consortium. Patients will be randomized in two groups – one treated with a traditional aspirin regimen and the other group with apixaban. The researchers will then assess long-term outcomes in the two groups to see if apixaban improves outcomes in stroke patients with atrial cardiopathy.
The trial will begin recruiting patients early this fall. The researchers will follow these patients for a minimum of a year and a half and a maximum of four years.
NewYork-Presbyterian, CUMC and Weill Cornell Medicine are among the nation’s leading providers of stroke care in the nation, treating approximately 2,000 stroke patients each year. In December 2013, investigators from NewYork-Presbyterian/Columbia University Irving Medical Center and NewYork-Presbyterian/Weill Cornell Medical Center created the New York Stroke Trials Network of Columbia and Cornell, one of 25 regional stroke centers across the country funded by the National Institutes of Health Stroke Trials Network (NIH StrokeNet).
Filed Under: Drug Discovery