Atorvastatin Versus Simvastatin In The Prevention Of Coronary Heart Disease (CHD) In Patients With Known CHD (IDEAL)

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ClinicalTrials.gov Identifier: NCT00159835

Recruitment Status : Completed

First Posted : September 12, 2005

Last Update Posted : April 22, 2015

Sponsor:

Information provided by:

Pfizer

Study Description

Brief Summary:

To investigate whether a long-term strategy to lower LDL cholesterol with atorvastatin as much as possible will improve prognosis in CHD patients compared with a strategy reflecting current best clinical practice with simvastatin.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases	Drug: atorvastatin Drug: simvastatin	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	8600 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Atorvastatin Compared With Simvastatin In The Prevention of CHD Morbidity And Mortality In Patients With CHD
Study Start Date :	February 1999
Study Completion Date :	March 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Time to of a major coronary event: 1) non-fatal acute myocardial infarction 2) coronary death 3) resuscitated cardiac arrest

Secondary Outcome Measures :

1) Time to any CHD event, 2) Time to Hospitalization with primary diagnosis of CHF, 3) Time to Cerbrovascular Event, 4) Time to PAD, 5) Time to any CV event and 6) All Cause Mortality

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 80 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previous myocardial infarction

Exclusion Criteria:

Women who are breast feeding or are pregnant

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159835

Show 193 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

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Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Publications of Results:

Pedersen TR, Faergeman O, Kastelein JJ, Olsson AG, Tikkanen MJ, Holme I, Larsen ML, Bendiksen FS, Lindahl C, Szarek M, Tsai J; Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) Study Group. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA. 2005 Nov 16;294(19):2437-45. Erratum in: JAMA. 2005 Dec 28;294(24):3092.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ports WC, Fayyad R, DeMicco DA, Laskey R, Wolk R. Effectiveness of Lipid-Lowering Statin Therapy in Patients With and Without Psoriasis. Clin Drug Investig. 2017 Aug;37(8):775-785. doi: 10.1007/s40261-017-0533-0.

Stam-Slob MC, van der Graaf Y, Greving JP, Dorresteijn JA, Visseren FL. Cost-Effectiveness of Intensifying Lipid-Lowering Therapy With Statins Based on Individual Absolute Benefit in Coronary Artery Disease Patients. J Am Heart Assoc. 2017 Feb 18;6(2). pii: e004648. doi: 10.1161/JAHA.116.004648.

Deedwania PC, Pedersen TR, DeMicco DA, Breazna A, Betteridge DJ, Hitman GA, Durrington P, Neil A; TNT, CARDS and IDEAL Steering Committees and Investigators. Differing predictive relationships between baseline LDL-C, systolic blood pressure, and cardiovascular outcomes. Int J Cardiol. 2016 Nov 1;222:548-556. doi: 10.1016/j.ijcard.2016.07.201. Epub 2016 Jul 30.

Stoekenbroek RM, Boekholdt SM, Fayyad R, Laskey R, Tikkanen MJ, Pedersen TR, Hovingh GK; Incremental Decrease in End Points Through Aggressive Lipid Lowering Study Group. High-dose atorvastatin is superior to moderate-dose simvastatin in preventing peripheral arterial disease. Heart. 2015 Mar;101(5):356-62. doi: 10.1136/heartjnl-2014-306906. Epub 2015 Jan 16.

Dorresteijn JA, Boekholdt SM, van der Graaf Y, Kastelein JJ, LaRosa JC, Pedersen TR, DeMicco DA, Ridker PM, Cook NR, Visseren FL. High-dose statin therapy in patients with stable coronary artery disease: treating the right patients based on individualized prediction of treatment effect. Circulation. 2013 Jun 25;127(25):2485-93. doi: 10.1161/CIRCULATIONAHA.112.000712. Epub 2013 May 14.

Semb AG, Kvien TK, DeMicco DA, Fayyad R, Wun CC, LaRosa JC, Betteridge J, Pedersen TR, Holme I. Effect of intensive lipid-lowering therapy on cardiovascular outcome in patients with and those without inflammatory joint disease. Arthritis Rheum. 2012 Sep;64(9):2836-46. doi: 10.1002/art.34524.

Hyde CL, Macinnes A, Sanders FA, Thompson JF, Mazzarella RA, Faergeman O, van Wijk DF, Wood L, Lira M, Paciga SA. Genetic association of the CCR5 region with lipid levels in at-risk cardiovascular patients. Circ Cardiovasc Genet. 2010 Apr;3(2):162-8. doi: 10.1161/CIRCGENETICS.109.897793. Epub 2010 Feb 3.

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ClinicalTrials.gov Identifier:	NCT00159835 History of Changes
Other Study ID Numbers:	ATV-N-98-001 A2581145
First Posted:	September 12, 2005 Key Record Dates
Last Update Posted:	April 22, 2015
Last Verified:	April 2015

Additional relevant MeSH terms:

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Cardiovascular Diseases Atorvastatin Simvastatin Anticholesteremic Agents Hypolipidemic Agents	Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

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