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)

Phase 3

Completed

• Conditions: Aortic Stenosis
• Interventions: Drug: ezetimibe (+) simvastatin

• Registration Number: NCT00092677
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2004-09-23
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-03-31
• Results First Submitted QC: 2009-03-31
• Results First Posted: 2009-05-27
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1873

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EZ/Simva 10/40 mg	ezetimibe (+) simvastatin	Ezetimibe 10 mg + Simvastatin 40 mg

Primary Outcome Measures

Name	Time	Method
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)	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 Outcome Measures

Name	Time	Method
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)	Composite endpoint of AVE (aortic valve events) consists of AVR surgery, CHF (as a result of progression of AS), or cardiovascular death
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)	Composite endpoint of ICE (ischemic cardiovascular events) consists of cardiovascular death, nonfatal MI, CABG, PCI, hospitalized unstable angina, and nonhemorrhagic stroke
Change From Baseline in Peak Transaortic Jet Velocity	Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement	Mean change from baseline in peak transaortic jet velocity