Astellas Pharama U.S., a co-development partner of Cardiome Pharma, has suspended patient enrollment for the ACT 5 study evaluating the safety and efficacy of vernakalant hydrochloride (Kynapid) injection, after cardiogenic shock occurred in an atrial fibrillation (AF) patient receiving the drug.
The randomized, double-blind, placebo controlled ACT 5 trial’s Data Safety Monitoring Board (DSMB) has reviewed the case and suggested that the trial continue, but the FDA has requested the full data from the South American trial site for further review.
The ACT 5 is set to enroll 470 patients at 100 sites and will study the safety and efficacy of vernakalant hydrochloride in patients with a recent onset—more than three hours but less than seven days—of AF.
"Patient safety has been and continues to be the primary concern of both Cardiome and Astellas," stated Doug Janzen, president and CEO of Cardiome. "We and Astellas will work closely with the clinical trial site, the DSMB and the FDA to review this serious adverse event, and seek to resume patient enrollment and treatment in the ACT 5 study as soon as it is appropriate to do so."