An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)

Organon and Co1,873 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,873

Conditions

Aortic Stenosis

Interventions

ezetimibe (+) simvastatinDRUG

Duration of Treatment: 4 years

Comparator: PlaceboDRUG

matching Placebo

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)

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

Time frame: Entire follow-up (median = 4.35 years)

Secondary Outcomes

Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)

Composite endpoint of AVE (aortic valve events) consists of AVR surgery, CHF (as a result of progression of AS), or cardiovascular death

Time frame: 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)

Composite endpoint of ICE (ischemic cardiovascular events) consists of cardiovascular death, nonfatal MI, CABG, PCI, hospitalized unstable angina, and nonhemorrhagic stroke

Time frame: Entire follow-up (median = 4.35 years)

Change From Baseline in Peak Transaortic Jet Velocity

Mean change from baseline in peak transaortic jet velocity

Time frame: Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement

Data from ClinicalTrials.gov

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