Sanofi-aventis said that the rationale of the trial was based on post-hoc findings from the Athena trial, in which a trend towards reduction of CV hospitalisation and death was seen in patients classified as ‘permanent’ (i.e. with AF/AFL at each ECG recording).
Pallas is a Phase IIIb trial comparing the efficacy of Multaq 400mg twice-daily with placebo in permanent AF patients. In the trial, all patients are expected to receive standard treatment to control heart rate and prevent blood clots (antithrombotic therapy); patients will be randomised to receive additional treatment with either Multaq 400mg BID or placebo.
The primary objective of the Pallas trial is to demonstrate a reduction in either or both of two composite outcomes which are major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or cardiovascular hospitalisation or death from any cause among patients with permanent atrial fibrillation and additional risk factors.
The secondary objectives are to evaluate the efficacy of Multaq in preventing cardiovascular death and whether the drug is well-tolerated in this patient population.
Stuart Connolly, one of the trial’s principal investigators, said: “This is a trial of major significance since no anti-arrhythmic drug has ever been shown to reduce major morbidity and mortality in permanent AF patients in a large-scale clinical trial. We designed the Pallas trial to further assess the role of Multaq to reduce cardiovascular outcomes in patients with AF.”
Marc Cluzel, executive vice president of research and development at sanofi-aventis, said: “The initiation of the Pallas trial confirms our strong belief in Multaq and our commitment to improve AF patient well-being and overall cardiovascular health. We are looking forward to first patient enrolment of Pallas in the third-quarter 2010.”