CARDIO-TTRansform
A Phase 3 Global, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 (Eplontersen) in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 1,438 patients with transthyretin amyloid cardiomyopathy, eplontersen was compared with placebo on cardiovascular death or recurrent cardiovascular events at 140 weeks.
N
1 438
Schéma
Phase 3 double-blind, placebo-controlled RCT, 1:1, subcutaneous dosing every 4 weeks for up to 140 weeks on top of local standard of care (TTR stabilisers permitted), followed by a 20-week post-treatment period or open-label extension
Critère
Composite of cardiovascular mortality and recurrent cardiovascular clinical events through week 140