A Phase IIIb randomized, double-blind clinical trial to study the clinical benefit of dronedarone (Multaq, Sanofi-Aventis) in more than 10,000 patients with atrial fibrillation will assess the drug's capability to reduce major adverse cardiovascular events (MACE).
According to Paris-based Sanofi, the PALLAS trial will evaluate two primary endpoints: whether patients with permanent AF treated with the drug have a decline in the number of MACE that occur and whether the drug will reduce cardiovascular (CV) hospitalizations or death from any cause.
Secondary endpoints will assess the ability of Multaq to prevent CV death and also how the drug is tolerated by these AF patients.
During the trial, patients will either receive a placebo or a 400 mg twice-daily dronedarone treatment. Both patient arms will receive anti-thrombotic therapy or drug treatment to control heart rates.
Eligible participants must be 65 years of age or older and have either systemic arterial embolism, MI, coronary artery disease, prior stroke or symptomatic heart failure.
Patients who are New York Heart Association Class IV HF or unstable Class III will be excluded. The trial will enroll 10,800 patients at 700 sites across 43 countries.
The PALLAS trial was initiated after results of the ATHENA trial showed that administering dronedarone on top of standard CV treatments reduced CV hospitalization or death by 24 percent.