Clinical trial NCT00159835: Atorvastatin Versus Simvastatin In The Prevention Of Coronary Heart Disease (CHD) In Patients With Known CHD
Official title: Atorvastatin Compared With Simvastatin In The Prevention of CHD Morbidity And Mortality In Patients With CHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 8600
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Previous myocardial infarction

Exclusion Criteria:

* Women who are breast feeding or are pregnant

Primary outcomes:
measure: Time to of a major coronary event: 1) non-fatal acute myocardial infarction 2) coronary death 3) resuscitated cardiac arrest
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Arhus C
country: Denmark
facility: Pfizer Investigational Site
city: Copenhagen
country: Denmark
facility: Pfizer Investigational Site
city: Esbjerg
country: Denmark
facility: Pfizer Investigational Site
city: Fredericia
country: Denmark
facility: Pfizer Investigational Site
city: Frederiksberg
country: Denmark
facility: Pfizer Investigational Site
city: Frederikssund
country: Denmark
facility: Pfizer Investigational Site
city: Grena
country: Denmark
facility: Pfizer Investigational Site
city: Helsingoer
country: Denmark
facility: Pfizer Investigational Site
city: Hjorring
country: Denmark
facility: Pfizer Investigational Site
city: Holbak
country: Denmark
facility: Pfizer Investigational Site
city: Holstebro
country: Denmark
facility: Pfizer Investigational Site
city: Hvidovre
country: Denmark
facility: Pfizer Investigational Site
city: Kabenhavn S
country: Denmark
facility: Pfizer Investigational Site
city: Kalundborg
country: Denmark
facility: Pfizer Investigational Site
city: Kobenhavn K
country: Denmark
facility: Pfizer Investigational Site
city: Kobenhavn Nv
country: Denmark
facility: Pfizer Investigational Site
city: Koge
country: Denmark
facility: Pfizer Investigational Site
city: KÃ¸benhavn NV
country: Denmark
facility: Pfizer Investigational Site
city: Middelfart
country: Denmark
facility: Pfizer Investigational Site
city: Naestved
country: Denmark
facility: Pfizer Investigational Site
city: Nykobing F
country: Denmark
facility: Pfizer Investigational Site
city: Odder
country: Denmark
facility: Pfizer Investigational Site
city: Randers
country: Denmark
facility: Pfizer Investigational Site
city: Roskilde
country: Denmark
facility: Pfizer Investigational Site
city: Silkeborg
country: Denmark
facility: Pfizer Investigational Site
city: Skive
country: Denmark
facility: Pfizer Investigational Site
city: Slagelse
country: Denmark
facility: Pfizer Investigational Site
city: Svendborg
country: Denmark
facility: Pfizer Investigational Site
city: Heinola
country: Finland
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Joensuu
country: Finland
facility: Pfizer Investigational Site
city: Jyvaskyla
country: Finland
facility: Pfizer Investigational Site
city: Kerava
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Lahti
country: Finland
facility: Pfizer Investigational Site
city: Lappeenranta
country: Finland
facility: Pfizer Investigational Site
city: Lohja
country: Finland
facility: Pfizer Investigational Site
city: Mikkeli
country: Finland
facility: Pfizer Investigational Site
city: Rauma
country: Finland
facility: Pfizer Investigational Site
city: Salo
country: Finland
facility: Pfizer Investigational Site
city: Siaraalamaki
country: Finland
facility: Pfizer Investigational Site
city: Tammisaari
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Vantaa
country: Finland
facility: Pfizer Investigational Site
city: Reykjavik
country: Iceland
facility: Pfizer Investigational Site
city: Reykjavik
country: Iceland
facility: Pfizer Investigational Site
city: 's-Hertogenbosch
country: Netherlands
facility: Pfizer Investigational Site
city: Alkmaar
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Assen
country: Netherlands
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Capelle Aan Den Ijssel
country: Netherlands
facility: Pfizer Investigational Site
city: Delft
country: Netherlands
facility: Pfizer Investigational Site
city: Deventer
country: Netherlands
facility: Pfizer Investigational Site
city: EDE
country: Netherlands
facility: Pfizer Investigational Site
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Enschede
country: Netherlands
facility: Pfizer Investigational Site
city: Goes
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Hoorn
country: Netherlands
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Oss
country: Netherlands
facility: Pfizer Investigational Site
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Tilburg
country: Netherlands
facility: Pfizer Investigational Site
city: Tilurg
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Weert
country: Netherlands
facility: Pfizer Investigational Site
city: Zwijndrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Zwolle
country: Netherlands
facility: Pfizer Investigational Site
city: Alesund
country: Norway
facility: Pfizer Investigational Site
city: Alesund
country: Norway
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Bodo
country: Norway
facility: Pfizer Investigational Site
city: Flekkefjord
country: Norway
facility: Pfizer Investigational Site
city: Forde
country: Norway
facility: Pfizer Investigational Site
city: Hammerfest
country: Norway
facility: Pfizer Investigational Site
city: Haugesund
country: Norway
facility: Pfizer Investigational Site
city: HobÃ¸l
country: Norway
facility: Pfizer Investigational Site
city: Jessheim
country: Norway
facility: Pfizer Investigational Site
city: Karasjok
country: Norway
facility: Pfizer Investigational Site
city: Kongsberg
country: Norway
facility: Pfizer Investigational Site
city: Kongsvinger
country: Norway
facility: Pfizer Investigational Site
city: Kragero
country: Norway
facility: Pfizer Investigational Site
city: Kristiansand
country: Norway
facility: Pfizer Investigational Site
city: Kristiansund N
country: Norway
facility: Pfizer Investigational Site
city: Larvik
country: Norway
facility: Pfizer Investigational Site
city: Levanger
country: Norway
facility: Pfizer Investigational Site
city: Lillestom
country: Norway
facility: Pfizer Investigational Site
city: Lorenskog
country: Norway
facility: Pfizer Investigational Site
city: Mo I Rana
country: Norway
facility: Pfizer Investigational Site
city: Molde
country: Norway
facility: Pfizer Investigational Site
city: Molde
country: Norway
facility: Pfizer Investigational Site
city: MosjÃ¸en
country: Norway
facility: Pfizer Investigational Site
city: Moss
country: Norway
facility: Pfizer Investigational Site
city: Mysen
country: Norway
facility: Pfizer Investigational Site
city: Nesttun
country: Norway
facility: Pfizer Investigational Site
city: Notodden
country: Norway
facility: Pfizer Investigational Site
city: Odda
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Paradis
country: Norway
facility: Pfizer Investigational Site
city: Porsgrunn
country: Norway
facility: Pfizer Investigational Site
city: Rud
country: Norway
facility: Pfizer Investigational Site
city: Sandvika
country: Norway
facility: Pfizer Investigational Site
city: Skedsmokorset
country: Norway
facility: Pfizer Investigational Site
city: Ski
country: Norway
facility: Pfizer Investigational Site
city: Stavanger
country: Norway
facility: Pfizer Investigational Site
city: Stavanger
country: Norway
facility: Pfizer Investigational Site
city: Stavanger
country: Norway
facility: Pfizer Investigational Site
city: Stavanger
country: Norway
facility: Pfizer Investigational Site
city: Stord
country: Norway
facility: Pfizer Investigational Site
city: Tansberg
country: Norway
facility: Pfizer Investigational Site
city: Tonsberg
country: Norway
facility: Pfizer Investigational Site
city: Trondheim
country: Norway
facility: Pfizer Investigational Site
city: Trondheim
country: Norway
facility: Pfizer Investigational Site
city: Tynset
country: Norway
facility: Pfizer Investigational Site
city: Volda
country: Norway
facility: Pfizer Investigational Site
city: Alingsas
country: Sweden
facility: Pfizer Investigational Site
city: Angelholm
country: Sweden
facility: Pfizer Investigational Site
city: Balsta
country: Sweden
facility: Pfizer Investigational Site
city: Boras
country: Sweden
facility: Pfizer Investigational Site
city: Eksjo
country: Sweden
facility: Pfizer Investigational Site
city: Eskilstuna
country: Sweden
facility: Pfizer Investigational Site
city: Fagersta
country: Sweden
facility: Pfizer Investigational Site
city: Falkoping
country: Sweden
facility: Pfizer Investigational Site
city: Falun
country: Sweden
facility: Pfizer Investigational Site
city: Finspang
country: Sweden
facility: Pfizer Investigational Site
city: Gateborg
country: Sweden
facility: Pfizer Investigational Site
city: Gavle
country: Sweden
facility: Pfizer Investigational Site
city: Gavle
country: Sweden
facility: Pfizer Investigational Site
city: Gavle
country: Sweden
facility: Pfizer Investigational Site
city: Gavle
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Gothenburg
country: Sweden
facility: Pfizer Investigational Site
city: Grastorp
country: Sweden
facility: Pfizer Investigational Site
city: Halmstad
country: Sweden
facility: Pfizer Investigational Site
city: Hassleholm
country: Sweden
facility: Pfizer Investigational Site
city: Hassleholm
country: Sweden
facility: Pfizer Investigational Site
city: Helsingborg
country: Sweden
facility: Pfizer Investigational Site
city: Helsingborg
country: Sweden
facility: Pfizer Investigational Site
city: Hudiksvall
country: Sweden
facility: Pfizer Investigational Site
city: Jonkoping
country: Sweden
facility: Pfizer Investigational Site
city: Kalmar
country: Sweden
facility: Pfizer Investigational Site
city: Karlshamn
country: Sweden
facility: Pfizer Investigational Site
city: Karlskoga
country: Sweden
facility: Pfizer Investigational Site
city: Karlskrona
country: Sweden
facility: Pfizer Investigational Site
city: Karlstad
country: Sweden
facility: Pfizer Investigational Site
city: Katarineholm
country: Sweden
facility: Pfizer Investigational Site
city: Koping
country: Sweden
facility: Pfizer Investigational Site
city: Kristinehamn
country: Sweden
facility: Pfizer Investigational Site
city: Lidkoping
country: Sweden
facility: Pfizer Investigational Site
city: Linka Ping
country: Sweden
facility: Pfizer Investigational Site
city: Ljungby
country: Sweden
facility: Pfizer Investigational Site
city: Ludvika
country: Sweden
facility: Pfizer Investigational Site
city: Lulea
country: Sweden
facility: Pfizer Investigational Site
city: Lycksele
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Mariestad
country: Sweden
facility: Pfizer Investigational Site
city: Molndal
country: Sweden
facility: Pfizer Investigational Site
city: Motala
country: Sweden
facility: Pfizer Investigational Site
city: Norrkoping
country: Sweden
facility: Pfizer Investigational Site
city: Sala
country: Sweden
facility: Pfizer Investigational Site
city: Sandviken
country: Sweden
facility: Pfizer Investigational Site
city: Skelleftea
country: Sweden
facility: Pfizer Investigational Site
city: Skene
country: Sweden
facility: Pfizer Investigational Site
city: Skovde
country: Sweden
facility: Pfizer Investigational Site
city: Sodertalje
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stromstad
country: Sweden
facility: Pfizer Investigational Site
city: Uddevalla
country: Sweden
facility: Pfizer Investigational Site
city: Umea
country: Sweden
facility: Pfizer Investigational Site
city: Varberg
country: Sweden
facility: Pfizer Investigational Site
city: Vastervik
country: Sweden
facility: Pfizer Investigational Site
city: VÃ¤nersborg
country: Sweden
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1001/jama.294.19.2437.
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citation: 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):e004648. doi: 10.1161/JAHA.116.004648.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.