Conducted in 35 centres in Korea, Taiwan, Hong Kong and India, the trial is designed to assess the safety and efficacy of intravenous Brinavess in patients with recent-onset AF lasting three hours to seven days.
Initially, the trial was planned to enroll 615 patients, however it was completed after randomizing 123 patients.
The trial remained sufficiently powered and it achieved the primary endpoint. The trial’s primary endpoint was conversion of recent-onset AF to normal heart rhythm for a period of at least one minute post-dosing within 90 minutes of the start of dosing.
Of the 111 treated patients with recent-onset AF lasting three hours to seven days, 53% of those receiving an IV dose of Brinavess converted to normal heart rhythm within 90 minutes, compared to 12% of placebo patients.
The results show that Brinavess was generally well-tolerated in the targeted patient population.
In the 30 day interval after drug administration, serious adverse events were seen in six placebo patients and seven patients dosed with Brinavess.
Cardiome medical director Dr Steen Juul-Möller said: "The results from this study provide additional support for rapid and effective cardioversion combined with high level of safety as observed in Brinavess Phase III clinical studies; ACT I and ACT III."