A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Ezetimibe + Simvastatin on Clinical Outcomes in Patients With Aortic Stenosis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 1,873
- Primary Endpoint
- Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)
Study Overview
Brief Summary
The purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 45 to 85 with mild abnormalities of the aortic valve as confirmed by an echocardiogram.
Exclusion Criteria
- •Patients previously in a trial using the study drug, or currently taking any medications that are not allowed in this study.
Arms & Interventions
EZ/Simva 10/40 mg
Ezetimibe 10 mg + Simvastatin 40 mg
Intervention: ezetimibe (+) simvastatin (Drug)
Outcomes
Primary Outcomes
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)
Time Frame: Entire follow-up (median = 4.35 years)
Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke
Secondary Outcomes
- Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)(Entire follow-up (median = 4.35 years))
- Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events)(Entire follow-up (median = 4.35 years))
- Change From Baseline in Peak Transaortic Jet Velocity(Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement)