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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,250
Nucresiran 300 mg administered SC q6M
Sterile Normal Saline (0.9% NaCl) administered SC once q6M
Composite outcome of all-cause mortality and recurrent cardiovascular [CV] events (CV hospitalizations and urgent heart failure [HF] visits)
All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) will be compared between treatment groups using an Andersen-Gill model.
Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)
Time to first CV event (CV hospitalizations and urgent HF visits) or all-cause mortality
Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)
All-cause mortality
Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)
Recurrent CV events (CV hospitalizations and urgent HF visits)
Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)
Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS)
The KCCQ is a 23-item self-administered questionnaire quantifying 6 domains (symptoms, physical function, quality of life, social limitation, self-efficacy, and symptom stability) and 2 summary scores (clinical and overall summary \[OS\]). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline to Month 30
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Clinical Trial Site
La Jolla, California, United States
RECRUITINGClinical Trial Site
Stanford, California, United States
RECRUITINGClinical Trial Site
Norwich, Connecticut, United States
RECRUITINGClinical Trial Site
Washington D.C., District of Columbia, United States
RECRUITINGClinical Trial Site
Brandon, Florida, United States
RECRUITINGClinical Trial Site
Miami, Florida, United States
RECRUITINGClinical Trial Site
Atlanta, Georgia, United States
RECRUITINGClinical Trial Site
Gainesville, Georgia, United States
RECRUITINGClinical Trial Site
Tucker, Georgia, United States
RECRUITINGClinical Trial Site
Indianapolis, Indiana, United States
RECRUITING...and 197 more locations