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Cardiovascular DiseasesPhase 4IDEALNCT00159835

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

A Phase 4 study testing atorvastatin and simvastatin in people with Cardiovascular Diseases, run by Pfizer at 194 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 80 years
Conditions the study is for
Cardiovascular Diseases
What is being tested?
atorvastatin and simvastatin
How many people
8,600 participants
Where
194 sitesin 7 countries
Study dates
Feb 1999to Mar 2005
Phase
Phase 4
Are there results?
None posted in the registry

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 Up to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Previous myocardial infarction

Who cannot join

  • Women who are breast feeding or are pregnant

Trial locations and contacts

194 sites in 7 countries.

194 sites in 7 countries

Sweden65 sites

  • Pfizer Investigational Site

    Alingsås, 441 83

  • Pfizer Investigational Site

    Ängelholm, 262 81

  • Pfizer Investigational Site

    Bålsta, 746 32

  • Pfizer Investigational Site

    Borås, 501 82

  • Pfizer Investigational Site

    Eksjö, 575 81

  • Pfizer Investigational Site

    Eskilstuna, 631 88

  • Pfizer Investigational Site

    Fagersta, 737 81

  • Pfizer Investigational Site

    Falköping, 521 85

  • Pfizer Investigational Site

    Falun, 791 82

  • Pfizer Investigational Site

    Finspång, 612 25

  • Pfizer Investigational Site

    Gateborg, 41345

  • Pfizer Investigational Site

    Gävle, 800 02

  • Pfizer Investigational Site

    Gävle, 801 87

  • Pfizer Investigational Site

    Gävle, 802 57

  • Pfizer Investigational Site

    Gävle, 802 84

  • Pfizer Investigational Site

    Gothenburg, 413 45

  • Pfizer Investigational Site

    Gothenburg, 417 17

  • Pfizer Investigational Site

    Grästorp, 46722

  • Pfizer Investigational Site

    Halmstad, 301 85

  • Pfizer Investigational Site

    Hässleholm, 281 25

  • Pfizer Investigational Site

    Hässleholm, 281 31

  • Pfizer Investigational Site

    Helsingborg, 252 20

  • Pfizer Investigational Site

    Helsingborg, 252 21

  • Pfizer Investigational Site

    Hudiksvall, 824 81

  • Pfizer Investigational Site

    Jönköping, 55185

  • Pfizer Investigational Site

    Kalmar, 391 85

  • Pfizer Investigational Site

    Karlshamn, 374 80

  • Pfizer Investigational Site

    Karlskoga, S-691 81

  • Pfizer Investigational Site

    Karlskrona, 371 85

  • Pfizer Investigational Site

    Karlstad, 651 85

  • Pfizer Investigational Site

    Katarineholm, 641 22

  • Pfizer Investigational Site

    Köping, 731 80

  • Pfizer Investigational Site

    Kristinehamn, 681 80

  • Pfizer Investigational Site

    Lidköping, 531 85

  • Pfizer Investigational Site

    Linka Ping, 581 85

  • Pfizer Investigational Site

    Ljungby, 341 82

  • Pfizer Investigational Site

    Ludvika, 771 81

  • Pfizer Investigational Site

    Luleå, 971 80

  • Pfizer Investigational Site

    Lycksele, 921 82

  • Pfizer Investigational Site

    Malmö, 205 02

  • Pfizer Investigational Site

    Malmö, 211 20

  • Pfizer Investigational Site

    Malmö, 211 38

  • Pfizer Investigational Site

    Malmö, 214 22

  • Pfizer Investigational Site

    Mariestad, 542 24

  • Pfizer Investigational Site

    Mölndal, 431 80

  • Pfizer Investigational Site

    Motala, 591 85

  • Pfizer Investigational Site

    Norrköping, 601 82

  • Pfizer Investigational Site

    Sala, 733 25

  • Pfizer Investigational Site

    Sandviken, 811 89

  • Pfizer Investigational Site

    Skellefteå, 931 86

  • Pfizer Investigational Site

    Skene, 511 81

  • Pfizer Investigational Site

    Skövde, 541 85

  • Pfizer Investigational Site

    Södertälje, 151 72

  • Pfizer Investigational Site

    Stockholm, 111 35

  • Pfizer Investigational Site

    Stockholm, 113 22

  • Pfizer Investigational Site

    Stockholm, 113 82

  • Pfizer Investigational Site

    Stockholm, 114 86

  • Pfizer Investigational Site

    Stockholm, 116 25

  • Pfizer Investigational Site

    Stockholm, 118 83

  • Pfizer Investigational Site

    Strömstad, 452 83

  • Pfizer Investigational Site

    Uddevalla, 451 80

  • Pfizer Investigational Site

    Umeå, 901 85

  • Pfizer Investigational Site

    Vänersborg, 46235

  • Pfizer Investigational Site

    Varberg, 432 81

  • Pfizer Investigational Site

    Västervik, 593 81

Other trials in Sweden

Norway58 sites

  • Pfizer Investigational Site

    Ålesund, 6002

  • Pfizer Investigational Site

    Ålesund, 6026

  • Pfizer Investigational Site

    Bergen, 5008

  • Pfizer Investigational Site

    Bergen, 5009

  • Pfizer Investigational Site

    Bergen, 5012

  • Pfizer Investigational Site

    Bergen, 5015

  • Pfizer Investigational Site

    Bergen, 5021

  • Pfizer Investigational Site

    Bodø, 8092

  • Pfizer Investigational Site

    Flekkefjord, 4400

  • Pfizer Investigational Site

    Førde, 6807

  • Pfizer Investigational Site

    Hammerfest, 9613

  • Pfizer Investigational Site

    Haugesund, 5500

  • Pfizer Investigational Site

    Hobøl, 1827

  • Pfizer Investigational Site

    Jessheim, 2050

  • Pfizer Investigational Site

    Karasjok, 9735

  • Pfizer Investigational Site

    Kongsberg, 3600

  • Pfizer Investigational Site

    Kongsvinger, 2226

  • Pfizer Investigational Site

    Kragerø, 3770

  • Pfizer Investigational Site

    Kristiansand, 4612

  • Pfizer Investigational Site

    Kristiansund N, 6508

  • Pfizer Investigational Site

    Larvik, 3257

  • Pfizer Investigational Site

    Levanger, 7600

  • Pfizer Investigational Site

    Lillestom, 2000

  • Pfizer Investigational Site

    Lorenskog, 1478

  • Pfizer Investigational Site

    Mo i Rana, 8607

  • Pfizer Investigational Site

    Molde, 6407

  • Pfizer Investigational Site

    Molde, 6415

  • Pfizer Investigational Site

    Mosjøen, 8656

  • Pfizer Investigational Site

    Moss, 1502

  • Pfizer Investigational Site

    Mysen, 1850

  • Pfizer Investigational Site

    Nesttun, 5221

  • Pfizer Investigational Site

    Notodden, 3675

  • Pfizer Investigational Site

    Odda, 5750

  • Pfizer Investigational Site

    Oslo, 0027

  • Pfizer Investigational Site

    Oslo, 0160

  • Pfizer Investigational Site

    Oslo, 0264

  • Pfizer Investigational Site

    Oslo, 0303

  • Pfizer Investigational Site

    Oslo, 0407

  • Pfizer Investigational Site

    Oslo, 0456

  • Pfizer Investigational Site

    Oslo, 0514

  • Pfizer Investigational Site

    Oslo, 0913

  • Pfizer Investigational Site

    Paradis, 5231

  • Pfizer Investigational Site

    Porsgrunn, 3922

  • Pfizer Investigational Site

    Rud, 1309

  • Pfizer Investigational Site

    Sandvika, 1301

  • Pfizer Investigational Site

    Skedsmokorset, N-2020

  • Pfizer Investigational Site

    Ski, 1400

  • Pfizer Investigational Site

    Stavanger, 4004

  • Pfizer Investigational Site

    Stavanger, 4006

  • Pfizer Investigational Site

    Stavanger, 4023

  • Pfizer Investigational Site

    Stavanger, 4095

  • Pfizer Investigational Site

    Stord, 5400

  • Pfizer Investigational Site

    Tansberg, 3191

  • Pfizer Investigational Site

    Tønsberg, 3103

  • Pfizer Investigational Site

    Trondheim, 7001

  • Pfizer Investigational Site

    Trondheim, 7011

  • Pfizer Investigational Site

    Tynset, 2500

  • Pfizer Investigational Site

    Volda, 6100

Other trials in Norway

Denmark28 sites

  • Pfizer Investigational Site

    Arhus C, DK-8000

  • Pfizer Investigational Site

    Copenhagen, 2100

  • Pfizer Investigational Site

    Elsinore, 3000

  • Pfizer Investigational Site

    Esbjerg, 6700

  • Pfizer Investigational Site

    Fredericia, 7000

  • Pfizer Investigational Site

    Frederiksberg, 2000

  • Pfizer Investigational Site

    Frederikssund, 3600

  • Pfizer Investigational Site

    Grenå, 8500

  • Pfizer Investigational Site

    Hjørring, 9800

  • Pfizer Investigational Site

    Holbak, 4300

  • Pfizer Investigational Site

    Holstebro, 7500

  • Pfizer Investigational Site

    Hvidovre, 2650

  • Pfizer Investigational Site

    København NV, 2400

  • Pfizer Investigational Site

    Kabenhavn S, 2300

  • Pfizer Investigational Site

    Kalundborg, 4400

  • Pfizer Investigational Site

    Kobenhavn K, 1256

  • Pfizer Investigational Site

    København NV, 2400

  • Pfizer Investigational Site

    Køge, 4600

  • Pfizer Investigational Site

    Middelfart, 5500

  • Pfizer Investigational Site

    Næstved, 4700

  • Pfizer Investigational Site

    Nykøbing Falster, 4800

  • Pfizer Investigational Site

    Odder, 8300

  • Pfizer Investigational Site

    Randers, 8900

  • Pfizer Investigational Site

    Roskilde, 4000

  • Pfizer Investigational Site

    Silkeborg, 8600

  • Pfizer Investigational Site

    Skive, 7800

  • Pfizer Investigational Site

    Slagelse, 4200

  • Pfizer Investigational Site

    Svendborg, 5700

Other trials in Denmark

Netherlands23 sites

  • Pfizer Investigational Site

    's-Hertogenbosch, 5211 NL

  • Pfizer Investigational Site

    Alkmaar, 1815 JD

  • Pfizer Investigational Site

    Amsterdam, 1061 AE

  • Pfizer Investigational Site

    Assen, 9401 RK

  • Pfizer Investigational Site

    Breda, 4818 CK

  • Pfizer Investigational Site

    Capelle aan den IJssel, 2906 ZC

  • Pfizer Investigational Site

    Delft, 2625 AD

  • Pfizer Investigational Site

    Deventer, 7415 CM

  • Pfizer Investigational Site

    Ede, 6716 RP

  • Pfizer Investigational Site

    Eindhoven, 5623 EJ

  • Pfizer Investigational Site

    Enschede, 7511 JX

  • Pfizer Investigational Site

    Goes, 4462 RA

  • Pfizer Investigational Site

    Groningen, 9721 SW

  • Pfizer Investigational Site

    Hoorn, 1624 GM

  • Pfizer Investigational Site

    Nijmegen, 6532 SZ

  • Pfizer Investigational Site

    Oss, NL-5342 BT

  • Pfizer Investigational Site

    Rotterdam, 3045 PM

  • Pfizer Investigational Site

    Tilburg, 5022 GC

  • Pfizer Investigational Site

    Tilurg, 5022 GC

  • Pfizer Investigational Site

    Utrecht, NL-3508-TG

  • Pfizer Investigational Site

    Weert, 6001 BE

  • Pfizer Investigational Site

    Zwijndrecht, 3331 LZ

  • Pfizer Investigational Site

    Zwolle, 8011 JW

Other trials in Netherlands

Finland17 sites

  • Pfizer Investigational Site

    Ekenäs, 10600

  • Pfizer Investigational Site

    Heinola, 18100

  • Pfizer Investigational Site

    Helsinki, 00029

  • Pfizer Investigational Site

    Helsinki, 00100

  • Pfizer Investigational Site

    Joensuu, 80210

  • Pfizer Investigational Site

    Jyväskylä, 40100

  • Pfizer Investigational Site

    Kerava, 04200

  • Pfizer Investigational Site

    Kuopio, 70210

  • Pfizer Investigational Site

    Lahti, 15110

  • Pfizer Investigational Site

    Lappeenranta, 53130

  • Pfizer Investigational Site

    Lohja, 08200

  • Pfizer Investigational Site

    Mikkeli, 50100

  • Pfizer Investigational Site

    Rauma, 26100

  • Pfizer Investigational Site

    Salo, 24130

  • Pfizer Investigational Site

    Siaraalamaki, 45750

  • Pfizer Investigational Site

    Tampere, 33520

  • Pfizer Investigational Site

    Vantaa, 01400

Other trials in Finland

Iceland2 sites

  • Pfizer Investigational Site

    Reykjavik, 101

  • Pfizer Investigational Site

    Reykjavik, 108

Other trials in Iceland

Location not given1 site

  • Pfizer Investigational Site

About this study

Official title: Atorvastatin Compared With Simvastatin In The Prevention of CHD Morbidity And Mortality In Patients With CHD

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.

Medical subject headings
Cardiovascular Diseases

What participants receive

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

What is being measured

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

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

Secondary outcomes (1)

  1. 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

Timeline

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

  1. First posted12 Sep 2005 (estimated)
  2. Study startFeb 1999
  3. Study completionMar 2005

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8,600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00159835
Sponsor's protocol ID
ATV-N-98-001
Other IDs
A2581145
Acronym
IDEAL
Status last verified
Apr 2015
First submitted
8 Sep 2005
Last updated
22 Apr 2015
Results posted
No

Publications

  • 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.

    PubMed 16287954

  • Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

    PubMed 38018702

  • 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.

    PubMed 28573499

  • 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.

    PubMed 28214794

  • 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.

    PubMed 27513651

  • 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.

    PubMed 25595417

  • 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.

    PubMed 23674398

  • 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.

    PubMed 22576673

  • 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.

    PubMed 20130232

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing atorvastatin and simvastatin in people with Cardiovascular Diseases, run by Pfizer at 194 sites in 7 countries.

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 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 194 sites in Sweden, Norway, Denmark, Netherlands, Finland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to of a major coronary event: 1) non-fatal acute myocardial infarction 2) coronary death 3) resuscitated cardiac arrest. 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 NCT00159835, which also lists 9 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 22 Apr 2015.

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