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)
NCT ID: NCT00092677
Last Updated: 2024-05-16
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1873 participants
Study Classification
INTERVENTIONAL
Study Start Date
2001-01-31
Study Completion Date
2008-04-30
Brief Summary
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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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Detailed Description
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Conditions
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Aortic Stenosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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EZ/Simva 10/40 mg
Ezetimibe 10 mg + Simvastatin 40 mg
Group Type
EXPERIMENTAL
ezetimibe (+) simvastatin
Intervention Type
DRUG
Duration of Treatment: 4 years
Placebo
Group Type
PLACEBO_COMPARATOR
Comparator: Placebo
Intervention Type
DRUG
matching Placebo
Interventions
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ezetimibe (+) simvastatin
Duration of Treatment: 4 years
Intervention Type
DRUG
Comparator: Placebo
matching Placebo
Intervention Type
DRUG
Other Intervention Names
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MK0653A
Eligibility Criteria
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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.
Minimum Eligible Age
45 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Organon and Co
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Bahlmann E, Gerdts E, Einarsen E, Midtbo H, Pedersen ER, Rossebo A, Willems S, Cramariuc D. Impact of sex-specific thresholds for low flow in assessment of prognosis in concordantly and discordantly graded aortic valve stenosis. Eur Heart J Cardiovasc Imaging. 2025 Jan 31;26(2):280-286. doi: 10.1093/ehjci/jeae272.
Reference Type
DERIVED
Hadziselimovic E, Greve AM, Sajadieh A, Olsen MH, Kesaniemi YA, Nienaber CA, Ray SG, Rossebo AB, Wachtell K, Nielsen OW. Association of high-sensitivity troponin T with outcomes in asymptomatic non-severe aortic stenosis: a post-hoc substudy of the SEAS trial. EClinicalMedicine. 2023 Feb 28;58:101875. doi: 10.1016/j.eclinm.2023.101875. eCollection 2023 Apr.
Reference Type
DERIVED
Bahlmann E, Einarsen E, Cramariuc D, Pedersen ER, Rossebo AB, Midtbo H, Willems S, Gerdts E. Prognosis in asymptomatic patients with discordantly graded aortic valve stenosis based on pressure recovery adjusted valve area. Open Heart. 2022 Nov;9(2):e002159. doi: 10.1136/openhrt-2022-002159.
Reference Type
DERIVED
Hadziselimovic E, Greve AM, Sajadieh A, Olsen MH, Kesaniemi YA, Nienaber CA, Ray SG, Rossebo AB, Willenheimer R, Wachtell K, Nielsen OW. Association of Annual N-Terminal Pro-Brain Natriuretic Peptide Measurements With Clinical Events in Patients With Asymptomatic Nonsevere Aortic Stenosis: A Post Hoc Substudy of the SEAS Trial. JAMA Cardiol. 2022 Apr 1;7(4):435-444. doi: 10.1001/jamacardio.2021.5916.
Reference Type
DERIVED
Bahlmann E, Einarsen E, Cramariuc D, Midtbo H, Mancusi C, Rossebo A, Willems S, Gerdts E. Low myocardial energetic efficiency is associated with increased mortality in aortic stenosis. Open Heart. 2021 Aug;8(2):e001720. doi: 10.1136/openhrt-2021-001720.
Reference Type
DERIVED
Einarsen E, Cramariuc D, Bahlmann E, Midtbo H, Chambers JB, Gerdts E. Higher Acceleration/Ejection Time Ratio Predicts Impaired Outcome in Aortic Valve Stenosis. Circ Cardiovasc Imaging. 2021 Jan;14(1):e011467. doi: 10.1161/CIRCIMAGING.120.011467. Epub 2021 Jan 19.
Reference Type
DERIVED
Greve AM, Bang CN, Boman K, Egstrup K, Kesaniemi YA, Ray S, Pedersen TR, Wachtell K. Relation of Lipid-Lowering Therapy to Need for Aortic Valve Replacement in Patients With Asymptomatic Mild to Moderate Aortic Stenosis. Am J Cardiol. 2019 Dec 1;124(11):1736-1740. doi: 10.1016/j.amjcard.2019.08.037. Epub 2019 Sep 7.
Reference Type
DERIVED
Gerdts E, Saeed S, Midtbo H, Rossebo A, Chambers JB, Einarsen E, Bahlmann E, Devereux R. Higher left ventricular mass-wall stress-heart rate product and outcome in aortic valve stenosis. Heart. 2019 Nov;105(21):1629-1633. doi: 10.1136/heartjnl-2018-314462. Epub 2019 Jun 1.
Reference Type
DERIVED
Bahlmann E, Cramariuc D, Saeed S, Chambers JB, Nienaber CA, Kuck KH, Lonnebakken MT, Gerdts E. Low systemic arterial compliance is associated with increased cardiovascular morbidity and mortality in aortic valve stenosis. Heart. 2019 Oct;105(19):1507-1514. doi: 10.1136/heartjnl-2018-314386. Epub 2019 May 15.
Reference Type
DERIVED
Hodges GW, Bang CN, Forman JL, Olsen MH, Boman K, Ray S, Kesaniemi YA, Eugen-Olsen J, Greve AM, Jeppesen JL, Wachtell K. Effect of simvastatin and ezetimibe on suPAR levels and outcomes. Atherosclerosis. 2018 May;272:129-136. doi: 10.1016/j.atherosclerosis.2018.03.030. Epub 2018 Mar 16.
Reference Type
DERIVED
Hodges GW, Bang CN, Eugen-Olsen J, Olsen MH, Boman K, Ray S, Kesaniemi AY, Jeppesen JL, Wachtell K. SuPAR predicts postoperative complications and mortality in patients with asymptomatic aortic stenosis. Open Heart. 2018 Jan 13;5(1):e000743. doi: 10.1136/openhrt-2017-000743. eCollection 2018.
Reference Type
DERIVED
Greve AM, Bang CN, Boman K, Egstrup K, Forman JL, Kesaniemi YA, Ray S, Pedersen TR, Best P, Rajamannan NM, Wachtell K. Effect Modifications of Lipid-Lowering Therapy on Progression of Aortic Stenosis (from the Simvastatin and Ezetimibe in Aortic Stenosis [SEAS] Study). Am J Cardiol. 2018 Mar 15;121(6):739-745. doi: 10.1016/j.amjcard.2017.12.011. Epub 2017 Dec 25.
Reference Type
DERIVED
Bang CN, Greve AM, Rossebo AB, Ray S, Egstrup K, Boman K, Nienaber C, Okin PM, Devereux RB, Wachtell K. Antihypertensive Treatment With beta-Blockade in Patients With Asymptomatic Aortic Stenosis and Association With Cardiovascular Events. J Am Heart Assoc. 2017 Nov 27;6(12):e006709. doi: 10.1161/JAHA.117.006709.
Reference Type
DERIVED
Saeed S, Senior R, Chahal NS, Lonnebakken MT, Chambers JB, Bahlmann E, Gerdts E. Lower Transaortic Flow Rate Is Associated With Increased Mortality in Aortic Valve Stenosis. JACC Cardiovasc Imaging. 2017 Aug;10(8):912-920. doi: 10.1016/j.jcmg.2017.05.008.
Reference Type
DERIVED
Thomassen HK, Cioffi G, Gerdts E, Einarsen E, Midtbo HB, Mancusi C, Cramariuc D. Echocardiographic aortic valve calcification and outcomes in women and men with aortic stenosis. Heart. 2017 Oct;103(20):1619-1624. doi: 10.1136/heartjnl-2016-311040. Epub 2017 Jul 11.
Reference Type
DERIVED
Lonnebakken MT, De Simone G, Saeed S, Boman K, Rossebo AB, Bahlmann E, Gohlke-Barwolf C, Gerdts E. Impact of stroke volume on cardiovascular risk during progression of aortic valve stenosis. Heart. 2017 Sep;103(18):1443-1448. doi: 10.1136/heartjnl-2016-310917. Epub 2017 Apr 28.
Reference Type
DERIVED
Bahlmann E, Cramariuc D, Minners J, Lonnebakken MT, Ray S, Gohlke-Baerwolf C, Nienaber CA, Jander N, Seifert R, Chambers JB, Kuck KH, Gerdts E. Small aortic root in aortic valve stenosis: clinical characteristics and prognostic implications. Eur Heart J Cardiovasc Imaging. 2017 Apr 1;18(4):404-412. doi: 10.1093/ehjci/jew159.
Reference Type
DERIVED
Nielsen OW, Sajadieh A, Sabbah M, Greve AM, Olsen MH, Boman K, Nienaber CA, Kesaniemi YA, Pedersen TR, Willenheimer R, Wachtell K. Assessing Optimal Blood Pressure in Patients With Asymptomatic Aortic Valve Stenosis: The Simvastatin Ezetimibe in Aortic Stenosis Study (SEAS). Circulation. 2016 Aug 9;134(6):455-68. doi: 10.1161/CIRCULATIONAHA.115.021213. Epub 2016 Aug 2.
Reference Type
DERIVED
Bang CN, Greve AM, La Cour M, Boman K, Gohlke-Barwolf C, Ray S, Pedersen T, Rossebo A, Okin PM, Devereux RB, Wachtell K. Effect of Randomized Lipid Lowering With Simvastatin and Ezetimibe on Cataract Development (from the Simvastatin and Ezetimibe in Aortic Stenosis Study). Am J Cardiol. 2015 Dec 15;116(12):1840-4. doi: 10.1016/j.amjcard.2015.09.026. Epub 2015 Oct 3.
Reference Type
DERIVED
Gerdts E, Rossebo AB, Pedersen TR, Cioffi G, Lonnebakken MT, Cramariuc D, Rogge BP, Devereux RB. Relation of Left Ventricular Mass to Prognosis in Initially Asymptomatic Mild to Moderate Aortic Valve Stenosis. Circ Cardiovasc Imaging. 2015 Nov;8(11):e003644; discussion e003644. doi: 10.1161/CIRCIMAGING.115.003644.
Reference Type
DERIVED
Blyme A, Asferg C, Nielsen OW, Sehestedt T, Kesaniemi YA, Gohlke-Barwolf C, Boman K, Willenheimer R, Ray S, Nienaber CA, Rossebo A, Wachtell K, Olsen MH. High sensitivity C reactive protein as a prognostic marker in patients with mild to moderate aortic valve stenosis during lipid-lowering treatment: an SEAS substudy. Open Heart. 2015 Feb 4;2(1):e000152. doi: 10.1136/openhrt-2014-000152. eCollection 2015.
Reference Type
DERIVED
Greve AM, Bang CN, Berg RM, Egstrup K, Rossebo AB, Boman K, Nienaber CA, Ray S, Gohlke-Baerwolf C, Nielsen OW, Okin PM, Devereux RB, Kober L, Wachtell K. Resting heart rate and risk of adverse cardiovascular outcomes in asymptomatic aortic stenosis: the SEAS study. Int J Cardiol. 2015 Feb 1;180:122-8. doi: 10.1016/j.ijcard.2014.11.181. Epub 2014 Nov 26.
Reference Type
DERIVED
Cramariuc D, Rogge BP, Lonnebakken MT, Boman K, Bahlmann E, Gohlke-Barwolf C, Chambers JB, Pedersen TR, Gerdts E. Sex differences in cardiovascular outcome during progression of aortic valve stenosis. Heart. 2015 Feb;101(3):209-14. doi: 10.1136/heartjnl-2014-306078. Epub 2014 Oct 9.
Reference Type
DERIVED
Jander N, Hochholzer W, Kaufmann BA, Bahlmann E, Gerdts E, Boman K, Chambers JB, Nienaber CA, Ray S, Rossebo A, Pedersen TR, Wachtell K, Gohlke-Barwolf C, Neumann FJ, Minners J. Velocity ratio predicts outcomes in patients with low gradient severe aortic stenosis and preserved EF. Heart. 2014 Dec;100(24):1946-53. doi: 10.1136/heartjnl-2014-305763. Epub 2014 Sep 12.
Reference Type
DERIVED
Greve AM, Dalsgaard M, Bang CN, Egstrup K, Rossebo AB, Boman K, Cramariuc D, Nienaber CA, Ray S, Gohlke-Baerwolf C, Okin PM, Devereux RB, Kober L, Wachtell K. Usefulness of the electrocardiogram in predicting cardiovascular mortality in asymptomatic adults with aortic stenosis (from the Simvastatin and Ezetimibe in Aortic Stenosis Study). Am J Cardiol. 2014 Sep 1;114(5):751-6. doi: 10.1016/j.amjcard.2014.06.006. Epub 2014 Jun 21.
Reference Type
DERIVED
Greve AM, Dalsgaard M, Bang CN, Egstrup K, Ray S, Boman K, Rossebo AB, Gohlke-Baerwolf C, Devereux RB, Kober L, Wachtell K. Stroke in patients with aortic stenosis: the Simvastatin and Ezetimibe in Aortic Stenosis study. Stroke. 2014 Jul;45(7):1939-46. doi: 10.1161/STROKEAHA.114.005296. Epub 2014 Jun 5.
Reference Type
DERIVED
Minners J, Gohlke-Baerwolf C, Kaufmann BA, Bahlmann E, Gerdts E, Boman K, Chambers JB, Nienaber CA, Willenheimer R, Wachtell K, Holme I, Pedersen TR, Neumann FJ, Jander N. Adjusting parameters of aortic valve stenosis severity by body size. Heart. 2014 Jul;100(13):1024-30. doi: 10.1136/heartjnl-2013-305225. Epub 2014 Apr 29.
Reference Type
DERIVED
Bahlmann E, Gerdts E, Cramariuc D, Gohlke-Baerwolf C, Nienaber CA, Wachtell K, Seifert R, Chambers JB, Kuck KH, Ray S. Prognostic value of energy loss index in asymptomatic aortic stenosis. Circulation. 2013 Mar 12;127(10):1149-56. doi: 10.1161/CIRCULATIONAHA.112.078857. Epub 2013 Jan 28.
Reference Type
DERIVED
Greve AM, Gerdts E, Boman K, Gohlke-Baerwolf C, Rossebo AB, Devereux RB, Kober L, Ray S, Willenheimer R, Wachtell K. Impact of QRS duration and morphology on the risk of sudden cardiac death in asymptomatic patients with aortic stenosis: the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Study. J Am Coll Cardiol. 2012 Mar 27;59(13):1142-9. doi: 10.1016/j.jacc.2011.12.020.
Reference Type
DERIVED
Holme I, Pedersen TR, Boman K, Egstrup K, Gerdts E, Kesaniemi YA, Malbecq W, Ray S, Rossebo AB, Wachtell K, Willenheimer R, Gohlke-Barwolf C. A risk score for predicting mortality in patients with asymptomatic mild to moderate aortic stenosis. Heart. 2012 Mar;98(5):377-83. doi: 10.1136/heartjnl-2011-300475. Epub 2011 Dec 8.
Reference Type
DERIVED
Greve AM, Boman K, Gohlke-Baerwolf C, Kesaniemi YA, Nienaber C, Ray S, Egstrup K, Rossebo AB, Devereux RB, Kober L, Willenheimer R, Wachtell K. Clinical implications of electrocardiographic left ventricular strain and hypertrophy in asymptomatic patients with aortic stenosis: the Simvastatin and Ezetimibe in Aortic Stenosis study. Circulation. 2012 Jan 17;125(2):346-53. doi: 10.1161/CIRCULATIONAHA.111.049759. Epub 2011 Dec 6.
Reference Type
DERIVED
Cramariuc D, Cioffi G, Rieck AE, Devereux RB, Staal EM, Ray S, Wachtell K, Gerdts E. Low-flow aortic stenosis in asymptomatic patients: valvular-arterial impedance and systolic function from the SEAS Substudy. JACC Cardiovasc Imaging. 2009 Apr;2(4):390-9. doi: 10.1016/j.jcmg.2008.12.021.
Reference Type
DERIVED
Peto R, Emberson J, Landray M, Baigent C, Collins R, Clare R, Califf R. Analyses of cancer data from three ezetimibe trials. N Engl J Med. 2008 Sep 25;359(13):1357-66. doi: 10.1056/NEJMsa0806603. Epub 2008 Sep 2.
Reference Type
DERIVED
Other Identifiers
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2004_050
Identifier Type: OTHER
Identifier Source: secondary_id
0653A-043
Identifier Type: -
Identifier Source: org_study_id
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