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
Washington D.C., District of Columbia, United States
NOT_YET_RECRUITINGClinical Trial Site
Brandon, Florida, United States
NOT_YET_RECRUITINGClinical Trial Site
Gainesville, Georgia, United States
RECRUITINGClinical Trial Site
Tucker, Georgia, United States
RECRUITINGClinical Trial Site
Boston, Massachusetts, United States
RECRUITINGClinical Trial Site
Detroit, Michigan, United States
NOT_YET_RECRUITINGClinical Trial Site
St Louis, Missouri, United States
RECRUITINGClinical Trial Site
Manhasset, New York, United States
NOT_YET_RECRUITINGClinical Trial Site
New York, New York, United States
NOT_YET_RECRUITINGClinical Trial Site
The Bronx, New York, United States
NOT_YET_RECRUITING...and 49 more locations