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)

May 8, 2024 updated by: Organon and Co

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1873

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Comparator: Placebo
matching Placebo
Experimental: EZ/Simva 10/40 mg
Ezetimibe 10 mg + Simvastatin 40 mg
Drug: ezetimibe (+) simvastatin
Duration of Treatment: 4 years
Other Names:
  • MK0653A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Entire follow-up (median = 4.35 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
Entire follow-up (median = 4.35 years)
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
Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Death
Time Frame: Entire follow-up (median = 4.35 years)
Number of participants that experienced cardiovascular death
Entire follow-up (median = 4.35 years)
Aortic Valve Replacement (AVR)
Time Frame: Entire follow-up (median = 4.35 years)
Number of participants that experienced aortic valve replacement (AVR)
Entire follow-up (median = 4.35 years)
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)
Entire follow-up (median = 4.35 years)
Nonfatal Myocardial Infarction (MI)
Time Frame: Entire follow-up (median = 4.35 years)
Number of participants that experienced nonfatal myocardial infarction (MI)
Entire follow-up (median = 4.35 years)
Coronary Artery Bypass Grafting (CABG)
Time Frame: Entire follow-up (median = 4.35 years)
Number of participants that experienced coronary artery bypass grafting (CABG)
Entire follow-up (median = 4.35 years)
Percutaneous Coronary Intervention (PCI)
Time Frame: Entire follow-up (median = 4.35 years)
Number of participants that experienced percutaneous coronary intervention (PCI)
Entire follow-up (median = 4.35 years)
Hospitalization for Unstable Angina
Time Frame: Entire follow-up (median = 4.35 years)
Number of participants that experienced hospitalization for unstable angina
Entire follow-up (median = 4.35 years)
Nonhemorrhagic Stroke
Time Frame: Entire follow-up (median = 4.35 years)
Number of participants that experienced nonhemorrhagic stroke
Entire follow-up (median = 4.35 years)
Death (Any Cause)
Time Frame: Entire follow-up (median = 4.35 years)
Number of participants that died (any cause)
Entire follow-up (median = 4.35 years)
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.
Baseline to End of follow-up (median = 4.35 years)
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.
Baseline to End of follow-up (median = 4.35 years)
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.
Baseline to End of follow-up (median = 4.35 years)
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.
Baseline to End of follow-up (median = 4.35 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Investigators

  • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 23, 2004

First Submitted That Met QC Criteria

September 27, 2004

First Posted (Estimated)

September 28, 2004

Study Record Updates

Last Update Posted (Estimated)

May 15, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0653A-043
  • 2004_050 (Other Identifier: Merck Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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