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)

Aortic Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092677
• Other study ID #: 0653A-043
• Secondary ID: 2004_050
• Status: Completed
• Phase: Phase 3
• Start date: January 2001
• Est. completion date: April 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1873
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Drug:
• ezetimibe (+) simvastatin
Duration of Treatment: 4 years
• Comparator: Placebo
matching Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (2)

Rossebo AB, Pedersen TR, Boman K, Brudi P, Chambers JB, Egstrup K, Gerdts E, Gohlke-Barwolf C, Holme I, Kesaniemi YA, Malbecq W, Nienaber CA, Ray S, Skjaerpe T, Wachtell K, Willenheimer R; SEAS Investigators. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med. 2008 Sep 25;359(13):1343-56. doi: 10.1056/NEJMoa0804602. Epub 2008 Sep 2. — View Citation

Steine K, Rossebo AB, Stugaard M, Pedersen TR. Left ventricular systolic and diastolic function in asymptomatic patients with moderate aortic stenosis. Am J Cardiol. 2008 Oct 1;102(7):897-901. doi: 10.1016/j.amjcard.2008.07.001. Epub 2008 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiovascular Death	Number of participants that experienced cardiovascular death	Entire follow-up (median = 4.35 years)
Other	Aortic Valve Replacement (AVR)	Number of participants that experienced aortic valve replacement (AVR)	Entire follow-up (median = 4.35 years)
Other	Congestive Heart Failure (CHF) Due to Progression of Aortic Stenosis (AS)	Number of participants that experienced Congestive Heart Failure (CHF) due to progression of aortic stenosis (AS)	Entire follow-up (median = 4.35 years)
Other	Nonfatal Myocardial Infarction (MI)	Number of participants that experienced nonfatal myocardial infarction (MI)	Entire follow-up (median = 4.35 years)
Other	Coronary Artery Bypass Grafting (CABG)	Number of participants that experienced coronary artery bypass grafting (CABG)	Entire follow-up (median = 4.35 years)
Other	Percutaneous Coronary Intervention (PCI)	Number of participants that experienced percutaneous coronary intervention (PCI)	Entire follow-up (median = 4.35 years)
Other	Hospitalization for Unstable Angina	Number of participants that experienced hospitalization for unstable angina	Entire follow-up (median = 4.35 years)
Other	Nonhemorrhagic Stroke	Number of participants that experienced nonhemorrhagic stroke	Entire follow-up (median = 4.35 years)
Other	Death (Any Cause)	Number of participants that died (any cause)	Entire follow-up (median = 4.35 years)
Other	Percent Change in Time Weighted Average Total Cholesterol From Baseline to End of Follow-up	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)
Other	Percent Change in Time Weighted Average Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to End of Follow-up	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)
Other	Percent Change in Time Weighted Average High-density Lipoprotein Cholesterol (HDL-C) From Baseline to End of Follow-up	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)
Other	Percent Change in Time Weighted Average Triglycerides From Baseline to End of Follow-up	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)
Primary	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	Entire follow-up (median = 4.35 years)
Secondary	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	Entire follow-up (median = 4.35 years)
Secondary	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	Entire follow-up (median = 4.35 years)
Secondary	Change From Baseline in Peak Transaortic Jet Velocity	Mean change from baseline in peak transaortic jet velocity	Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement