A pragmatic clinical trial—CHANGE AFib—will determine whether early treatment with the antiarrhythmic drug dronedarone improves cardiovascular and long-term outcomes in patients presenting with first-detected atrial fibrillation (AF). The trial represents a collaboration between the American Heart Association (AHA) and the Duke Clinical Research Institute (DCRI), with support from Sanofi US.
According to a press release from AHA, patients with AF are hospitalised twice as often as patients without AF and are three times more likely to have multiple admissions. According to a report published in the journal Circulation, up to 84% of strokes in AF patients could be prevented with effective treatment, but about half of patients do not receive proper therapy.
”Although several clinical trials have addressed the optimal treatment strategy for patients with symptomatic and recurrent AF, we do not yet have evidence on the best early treatment plan for those who have just been diagnosed with first-detected cases,” said Jonathan Piccini, cardiac electrophysiologist and associate professor of medicine at Duke University (Durham, USA) and principal investigator for the trial. “CHANGE AFib seeks to fill this gap in evidence and determine whether we can better deliver early treatment to help improve long-term outcomes in patients with first-detected AF.”
The CHANGE AFib trial will conclude in 2024 and will be conducted using patient data from hospitals participating in the AHA’s Get With The Guidelines–AFib registry.
“It is estimated that by 2030, atrial fibrillation will affect 12.1 million people in the USA, more than double the number in 2010,” said Mariell Jessup, chief staff science and medical officer at the AHA. “People living with AF are nearly five times more likely to have a stroke. Establishing treatment options for newly diagnosed patients is an integral part of a care plan that helps them live longer, healthier lives.”
“We are honoured to support the AHA and the Duke Clinical Research Institute on this important initiative that could potentially shift the paradigm of how we take care of people living with AF,” said Rogelio Braceras, North America head of medical for General Medicines, Sanofi. “CHANGE AFib represents a unique opportunity to investigate the role of dronedarone when used early in the course of the condition.”