Aortic StenosisPhase 3NCT00092677

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)

A Phase 3 study testing ezetimibe (+) simvastatin in people with Aortic Stenosis, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 45 to 85 years
Conditions the study is for: Aortic Stenosis
What is being tested?: ezetimibe (+) simvastatin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,873 participants
Where: No sites listed yet
Study dates: Jan 2001to Apr 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients aged 45 to 85 with mild abnormalities of the aortic valve as confirmed by an echocardiogram.

Who cannot join

Patients previously in a trial using the study drug, or currently taking any medications that are not allowed in this study.

About this study

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

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.

Conditions: Aortic Stenosis
Being tested: ezetimibe (+) simvastatin, Comparator: Placebo
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ezetimibe (+) simvastatinDrug
Also called MK0653A
Duration of Treatment: 4 years
Comparator: PlaceboDrug
matching Placebo

Study groups in NCT00092677
Study group	Role	What they receive
EZ/Simva 10/40 mg	Experimental	Ezetimibe 10 mg + Simvastatin 40 mg Receives: Drug: ezetimibe (+) simvastatin
Placebo	Placebo comparator	Not described Receives: Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Entire follow-up (median = 4.35 years)

Secondary outcomes (3)

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
Measured: 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)
Composite endpoint of ICE (ischemic cardiovascular events) consists of cardiovascular death, nonfatal MI, CABG, PCI, hospitalized unstable angina, and nonhemorrhagic stroke
Measured: Entire follow-up (median = 4.35 years)
Change From Baseline in Peak Transaortic Jet Velocity
Mean change from baseline in peak transaortic jet velocity
Measured: Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2001Apr 2008

First posted28 Sep 2004 (estimated)
Study startJan 2001
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Aortic StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,873 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00092677
Sponsor's protocol ID: 0653A-043
Other IDs: 2004_050
Status last verified: Feb 2022
First submitted: 23 Sep 2004
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

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.
PubMed 18765433
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.
PubMed 18805118
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.
PubMed 39467305
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.
PubMed 36915288
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.
PubMed 36428084
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.
PubMed 35171199
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.
PubMed 34426527
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.
PubMed 33461302
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.
PubMed 31586530
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.
PubMed 31154431
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.
PubMed 31092548
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.
PubMed 29602140
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.
PubMed 29387432
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.
PubMed 29361285
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.
PubMed 29180457

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00092677
Acronym / sponsor ID: 0653A-043
Conditions: Aortic Stenosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,873 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jan 2001
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 28 Sep 2004 (estimated)
Results: Posted 27 May 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
EZ/Simva 10/40 mg	Experimental	Drug: ezetimibe (+) simvastatinEzetimibe 10 mg + Simvastatin 40 mg
Placebo	Placebo comparator	Drug: Comparator: Placebo

Who may qualify

Ages: 45 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients aged 45 to 85 with mild abnormalities of the aortic valve as confirmed by an echocardiogram.

Key exclusion criteria (1 listed)

Patients previously in a trial using the study drug, or currently taking any medications that are not allowed in this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ezetimibe (+) simvastatinAlso: MK0653ADuration of Treatment: 4 years	Drug	EZ/Simva 10/40 mg
Comparator: Placebomatching Placebo	Drug	Placebo

Primary outcome

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

3 secondary outcomes

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)
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)
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

Results and safety

Results posted to the registry on 27 May 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EZ/Simva 10/40 mg	944	939
Placebo	929	918

Primary outcome: 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). Number. Unit: Participants

Measure	EZ/Simva 10/40 mg n = 944	Placebo n = 929
Value	333	355

EZ/Simva 10/40 mg vs Placebo: Hazard Ratio (HR): 0.960 (95% CI 0.826 to 1.115), p = 0.591, Regression, Cox

Population analysed: Intention-to-Treat

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EZ/Simva 10/40 mg	471 of ?	703 of ?	Not reported
Placebo	465 of ?	706 of ?	Not reported

Limitations and caveats (from the sponsor): It is important to note that several of the ischemic outcomes making up the composite ischemic endpoint can occur as a causal consequence of aortic stenosis progression itself, or in association with its standard treatment (aortic valve replacement).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18765433Rossebo 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.
Background: PubMed 18805118Steine 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.
Derived from this study: PubMed 39467305Bahlmann 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.
Derived from this study: PubMed 36915288Hadziselimovic 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.
Derived from this study: PubMed 36428084Bahlmann 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.
Derived from this study: PubMed 35171199Hadziselimovic 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.
Derived from this study: PubMed 34426527Bahlmann 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.
Derived from this study: PubMed 33461302Einarsen 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.
Derived from this study: PubMed 31586530Greve 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.
Derived from this study: PubMed 31154431Gerdts 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.
Derived from this study: PubMed 31092548Bahlmann 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.
Derived from this study: PubMed 29602140Hodges 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.
Individual participant dataSharing planned: No

Related trials for Aortic Stenosis

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Aortic Stenosis Treated With TAVI, Aortic Diseases
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ezetimibe (+) simvastatin in people with Aortic Stenosis, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00092677, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.