Clinical trial NCT00092677: 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)
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Ezetimibe + Simvastatin on Clinical Outcomes in Patients With Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aortic Stenosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 1873
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)
timeFrame: Entire follow-up (median = 4.35 years)
Secondary outcomes:
measure: Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)
timeFrame: Entire follow-up (median = 4.35 years)
measure: Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events)
timeFrame: Entire follow-up (median = 4.35 years)
measure: Change From Baseline in Peak Transaortic Jet Velocity
timeFrame: Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement
Other outcomes:
measure: Cardiovascular Death
timeFrame: Entire follow-up (median = 4.35 years)
measure: Aortic Valve Replacement (AVR)
timeFrame: Entire follow-up (median = 4.35 years)
measure: Congestive Heart Failure (CHF) Due to Progression of Aortic Stenosis (AS)
timeFrame: Entire follow-up (median = 4.35 years)
measure: Nonfatal Myocardial Infarction (MI)
timeFrame: Entire follow-up (median = 4.35 years)
measure: Coronary Artery Bypass Grafting (CABG)
timeFrame: Entire follow-up (median = 4.35 years)
measure: Percutaneous Coronary Intervention (PCI)
timeFrame: Entire follow-up (median = 4.35 years)
measure: Hospitalization for Unstable Angina
timeFrame: Entire follow-up (median = 4.35 years)
measure: Nonhemorrhagic Stroke
timeFrame: Entire follow-up (median = 4.35 years)
measure: Death (Any Cause)
timeFrame: Entire follow-up (median = 4.35 years)
measure: Percent Change in Time Weighted Average Total Cholesterol From Baseline to End of Follow-up
timeFrame: Baseline to End of follow-up (median = 4.35 years)
measure: Percent Change in Time Weighted Average Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to End of Follow-up
timeFrame: Baseline to End of follow-up (median = 4.35 years)
measure: Percent Change in Time Weighted Average High-density Lipoprotein Cholesterol (HDL-C) From Baseline to End of Follow-up
timeFrame: Baseline to End of follow-up (median = 4.35 years)
measure: Percent Change in Time Weighted Average Triglycerides From Baseline to End of Follow-up
timeFrame: Baseline to End of follow-up (median = 4.35 years)
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
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