Trial will enroll 1,100 patients to gain insights into stroke risk factors and secondary stroke prevention

Aug 15, 2017
NewYork-Presbyterian
New York - 

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).

For more information about the ARCADIA trial, visit clinicaltrials.gov.

NewYork-Presbyterian

NewYork-Presbyterian is one of the nation’s most comprehensive, integrated academic healthcare delivery systems, whose organizations are dedicated to providing the highest quality, most compassionate care and service to patients in the New York metropolitan area, nationally, and throughout the globe. In collaboration with two renowned medical schools, Weill Cornell Medicine and Columbia University Medical Center, NewYork-Presbyterian is consistently recognized as a leader in medical education, groundbreaking research and innovative, patient-centered clinical care.

NewYork-Presbyterian has four major divisions:

  • NewYork-Presbyterian Hospital is ranked #1 in the New York metropolitan area by U.S. News and World Report and repeatedly named to the Honor Roll of “America’s Best Hospitals.”
  • NewYork-Presbyterian Regional Hospital Network comprises hospitals and other facilities in the New York metropolitan region.
  • NewYork-Presbyterian Physician Services, which connects medical experts with patients in their communities.
  • NewYork-Presbyterian Community and Population Health, encompassing ambulatory care network sites and community healthcare initiatives, including NewYork Quality Care, the Accountable Care Organization jointly established by NewYork-Presbyterian Hospital, Weill Cornell Medicine and Columbia.

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Columbia University Medical Center

Columbia University Medical Center provides international leadership in basic, preclinical, and clinical research; medical and health sciences education; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Columbia University Medical Center is home to the largest medical research enterprise in New York City and State and one of the largest faculty medical practices in the Northeast. The campus that Columbia University Medical Center shares with its hospital partner, NewYork-Presbyterian, is now called the Columbia University Irving Medical Center. For more information, visit cumc.columbia.edu or columbiadoctors.org.

Weill Cornell Medicine

Weill Cornell Medicine is committed to excellence in patient care, scientific discovery and the education of future physicians in New York City and around the world. The doctors and scientists of Weill Cornell Medicine — faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and Weill Cornell Physician Organization—are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies. Located in the heart of the Upper East Side's scientific corridor, Weill Cornell Medicine's powerful network of collaborators extends to its parent university Cornell University; to Qatar, where an international campus offers a U.S. medical degree; and to programs in Tanzania, Haiti, Brazil, Austria and Turkey. Weill Cornell Medicine faculty provide comprehensive patient care at NewYork-Presbyterian/Weill Cornell Medical Center, NewYork-Presbyterian Lower Manhattan Hospital and NewYork-Presbyterian Queens. Weill Cornell Medicine is also affiliated with Houston Methodist. For more information, visit weill.cornell.edu.

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