TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Condition(s) studied

Investigational drug(s) / intervention(s)

Nucresiran: Nucresiran 300 mg administered SC q6M

Sterile Normal Saline (0.9% NaCl): Sterile Normal Saline (0.9% NaCl) administered SC once q6M

Study summary

The purpose of this study is to:

* Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events
* Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death
* Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life

Eligibility

Primary outcome measure(s)

• Composite outcome of all-cause mortality and recurrent cardiovascular [CV] events (CV hospitalizations and urgent heart failure [HF] visits) — Baseline to end of double-blind period (estimated 32 months, maximum 5 years)
  All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) will be compared between treatment groups using an Andersen-Gill model.

Trial sites (251)

+ 211 more sites — see the full list on the official registry below.