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.
Is 18 years or older for patients with established cardiovascular disease (CVD)
Is 55 years or older for patients with high risk for CVD
Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic
Has known history of secondary hypertension
Has symptomatic orthostatic hypotension
Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3×upper limit of normal (ULN)
Has total serum bilirubin >1.5×ULN
Parallel
Zilebesiran
DrugZilebesiran will be administered SC
Placebo
DrugPlacebo will be administered SC
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)
Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6
Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke
Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit)
Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization
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Alnylam Pharmaceuticals
Lead sponsor
Hoffmann-La Roche
Collaborator
