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Completed

NCT Number: 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)

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ezetimibe (+) simvastatin

Drug

Duration of Treatment: 4 years

Other names: MK0653A

Comparator: placebo

Drug

matching Placebo

Primary outcomes

  1. 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

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

    Time frame: 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

  2. Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events)

    Time frame: 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

  3. 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

    Mean change from baseline in peak transaortic jet velocity

Other outcomes

  1. Cardiovascular Death

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

    Number of participants that experienced cardiovascular death

  2. Aortic Valve Replacement (AVR)

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

    Number of participants that experienced aortic valve replacement (AVR)

  3. Congestive Heart Failure (CHF) Due to Progression of Aortic Stenosis (AS)

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

    Number of participants that experienced Congestive Heart Failure (CHF) due to progression of aortic stenosis (AS)

  4. Nonfatal Myocardial Infarction (MI)

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

    Number of participants that experienced nonfatal myocardial infarction (MI)

  5. Coronary Artery Bypass Grafting (CABG)

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

    Number of participants that experienced coronary artery bypass grafting (CABG)

  6. Percutaneous Coronary Intervention (PCI)

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

    Number of participants that experienced percutaneous coronary intervention (PCI)

  7. Hospitalization for Unstable Angina

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

    Number of participants that experienced hospitalization for unstable angina

  8. Nonhemorrhagic Stroke

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

    Number of participants that experienced nonhemorrhagic stroke

  9. Death (Any Cause)

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

    Number of participants that died (any cause)

  10. Percent Change in Time Weighted Average Total Cholesterol From Baseline to End of Follow-up

    Time frame: Baseline to End of follow-up (median = 4.35 years)

    Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.

  11. Percent Change in Time Weighted Average Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to End of Follow-up

    Time frame: Baseline to End of follow-up (median = 4.35 years)

    Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.

  12. Percent Change in Time Weighted Average High-density Lipoprotein Cholesterol (HDL-C) From Baseline to End of Follow-up

    Time frame: Baseline to End of follow-up (median = 4.35 years)

    Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.

  13. Percent Change in Time Weighted Average Triglycerides From Baseline to End of Follow-up

    Time frame: Baseline to End of follow-up (median = 4.35 years)

    Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Ezetimibe + Simvastatin on Clinical Outcomes in Patients With Aortic Stenosis

Important dates

Study start
2001
Primary completion
2008
Study completion
2008
First posted
Sep 28, 2004
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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