The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11,000
Zilebesiran will be administered SC
Placebo will be administered SC
Clinical Trial Site
Birmingham, Alabama, United States
RECRUITINGClinical Trial Site
Birmingham, Alabama, United States
RECRUITINGClinical Trial Site
Fairhope, Alabama, United States
RECRUITINGClinical Trial Site
Foley, Alabama, United States
Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit)
Time frame: Up to approximately 5 years
Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6
Time frame: Baseline and Month 6
Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke
Time frame: Up to approximately 5 years
Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit)
Time frame: Up to approximately 5 years
Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization
Time frame: Up to approximately 5 years
Time to All-cause Death
Time frame: Up to approximately 5 years
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Clinical Trial Site
Huntsville, Alabama, United States
NOT_YET_RECRUITINGClinical Trial Site
Huntsville, Alabama, United States
RECRUITINGClinical Trial Site
Sheffield, Alabama, United States
RECRUITINGClinical Trial Site
Chandler, Arizona, United States
RECRUITINGClinical Trial Site
Gilbert, Arizona, United States
RECRUITINGClinical Trial Site
Glendale, Arizona, United States
NOT_YET_RECRUITING...and 846 more locations