Additional Relevant Details
The ENDEAVOUR Phase 3 trial is a randomized, double-blind, placebo-controlled, global study designed to evaluate the efficacy and safety of revusiran in patients with hATTR-CM. The co-primary endpoints of the study are the change compared to baseline in six-minute walk distance (6-MWD) and the percent reduction in TTR level between placebo- and revusiran-treated patients at 18 months. Secondary endpoints include a composite endpoint of cardiovascular (CV) mortality and cardiovascular hospitalization, New York Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ), and all-cause mortality. The trial was designed to enroll up to 200 hATTR-CM patients with a documented TTR mutation, including V122I or other mutations, in addition to amyloid deposits as identified by biopsy or technetium scan. Patients were randomized 2:1, revusiran to placebo, with revusiran administered subcutaneously at 500 mg daily for five days then weekly for 18 months.