CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events
CARDS
A Double Blind Placebo Controlled Study of Atorvastatin as Prevention of CHD in High Risk Patients With Non-Insulin Dependent Diabetes Mellitus (Collaborative Atorvastatin Study - CARDS)
2 other identifiers
interventional
2,800
1 country
135
Brief Summary
A study to assess the efficacy of once daily atorvastatin 10 mg versus placebo on cardiovascular endpoints in patients with non-insulin-dependent diabetes mellitus (NIDDM) who have a history of either hypertension, retinopathy, microalbuminuria, macroalbuminuria, or who currently smoke, but who do not have established corornary heart disease or other macrovascular disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 1997
Longer than P75 for phase_4
135 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 16, 2006
CompletedFirst Posted
Study publicly available on registry
May 18, 2006
CompletedMay 10, 2007
May 1, 2007
May 16, 2006
May 8, 2007
Conditions
Outcome Measures
Primary Outcomes (3)
Time from randomization to the occurrence of a primary clinical endpoint
i.e. major coronary event or CABG or other coronary revascularization procedure
or unstable angina or resuscitated cardiac arrest or stroke.
Secondary Outcomes (4)
The incidence rate of a primary clinical and endpoint; the time from randomization
to the occurrence of and the incidence rate of other parameters e.g. total
mortality, any cardiovascular event, new PVD etc. and the percent change from
baseline in various lipid and lipoprotein parameters.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have a documented history of at least one of the following:
- Hypertension (defined as systolic blood pressure 140 mmHg or a diastolic blood pressure 90 mmHg (defined as the disapperance of all sound \[Korotkoff Phase V\] or receiving anti-hypertensive treatment. Blood pressure should be measured after sitting the patient quietly for 3 minutes).
- Retinopathy (defined as any of the following; non-proliferative retinopathy, pre-pre-proliferative retinopathy, proliferative retinopathy, maculopathy, advanced diabetic eye disease or history of photocoagulation).
- Microalbuminuria (defined as either, Albumin creatinine ratio \> than = to 2.5 mg/mmol, or Albumin excretion rate on a timed collection \> than = to 20 mcg/min (\> than = to 30 mg/24hrs) on two successive occasions, or a positive micral or other strip test).
- Macroalbuminuria (defined as either; Albustix or other dipstick evidence of gross proteinuria, Albumin creatinine ratio \> than = to 25 mg/mmol; or Albumin excretion rate on a timed collection \> than = 200 mcg/min (\> than = 300 mg/24hrs) on two sucessive occasions).
- Current smoker
You may not qualify if:
- Type I Diabetes Mellitus
- Any major Coronary event prior to entry into the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Diabetes UKcollaborator
- Department of Health, United Kingdomcollaborator
Study Sites (135)
Pfizer Investigational Site
Fosterhill, Aberdeen, AB25 2XG, United Kingdom
Pfizer Investigational Site
Irvine, Ayrshire, KA12 0AY, United Kingdom
Pfizer Investigational Site
Midsomer Norton, Bath, BA3 2UH, United Kingdom
Pfizer Investigational Site
Reading, Berkshire, RG2 7AG, United Kingdom
Pfizer Investigational Site
Slough, Berkshire, SL1 2AD, United Kingdom
Pfizer Investigational Site
Maidenhead, Berskhire, SL6 6EL, United Kingdom
Pfizer Investigational Site
Edgbaston, Birmingham, B15 2TH, United Kingdom
Pfizer Investigational Site
Frenchay, Bristol, BS16 1LE, United Kingdom
Pfizer Investigational Site
Llanishen, Cardiff, CF14 5GJ, United Kingdom
Pfizer Investigational Site
Wrexham, Clwydd, LL13 7TD, United Kingdom
Pfizer Investigational Site
Bocastle, Cornwall, PL35 0BG, United Kingdom
Pfizer Investigational Site
Falmouth, Cornwall, TR11 2LH, United Kingdom
Pfizer Investigational Site
Fowey, Cornwall, PL23 1DT, United Kingdom
Pfizer Investigational Site
Penzance, CORNWALL, TR18 4JH, United Kingdom
Pfizer Investigational Site
Penzance, Cornwall, TR19 7HX, United Kingdom
Pfizer Investigational Site
Redruth, Cornwall, TR15 2LL, United Kingdom
Pfizer Investigational Site
Saltash, CORNWALL, PL12 6DL, United Kingdom
Pfizer Investigational Site
St Austell, Cornwall, PL26 7RL, United Kingdom
Pfizer Investigational Site
Truro, Cornwall, TR1 3LJ, United Kingdom
Pfizer Investigational Site
Chesterfield, Derbyshire, S40 4TF, United Kingdom
Pfizer Investigational Site
Crownhill, Plymouth, DEVON, PL5 3JB, United Kingdom
Pfizer Investigational Site
Plymouth, Devon, PL6 7TH, United Kingdom
Pfizer Investigational Site
Plympton, Devon, PL7 1AD, United Kingdom
Pfizer Investigational Site
Bournemouth, Dorset, BH7 7DW, United Kingdom
Pfizer Investigational Site
Bournemouth, Dorset, BH8 9EW, United Kingdom
Pfizer Investigational Site
Epping, Essex, CM16 6TN, United Kingdom
Pfizer Investigational Site
Southend-on-Sea, Essex, SS1 2AB, United Kingdom
Pfizer Investigational Site
Langside, Glasgow, G42 9TY, United Kingdom
Pfizer Investigational Site
Portsmouth, Hampshire, PO6 3LY, United Kingdom
Pfizer Investigational Site
Southampton, Hampshire, SO31 7DQ, United Kingdom
Pfizer Investigational Site
Titchfield, Hampshire, PO14 4EH, United Kingdom
Pfizer Investigational Site
Hemel Hempstead, Hertfordshire, HP2 4AD, United Kingdom
Pfizer Investigational Site
Watford, Hertfordshire, WD18 0HB, United Kingdom
Pfizer Investigational Site
Ryde, Isle of Wight, PO33 2EH, United Kingdom
Pfizer Investigational Site
Gillingham, Kent, ME7 5NY, United Kingdom
Pfizer Investigational Site
Hildenborough, Kent, TN11 9HL, United Kingdom
Pfizer Investigational Site
Royal Tunbridge Wells, Kent, TN1 2DX, United Kingdom
Pfizer Investigational Site
Bolton, Lancashire, BL4 0JR, United Kingdom
Pfizer Investigational Site
Ormskirk, Lancashire, L39 2AZ, United Kingdom
Pfizer Investigational Site
Waterloo, Liverpool, L22 0LG, United Kingdom
Pfizer Investigational Site
Manchester, M15 6SX, United Kingdom
Pfizer Investigational Site
Ashford, Middlesex, TW15 2TU, United Kingdom
Pfizer Investigational Site
Southall, Middlesex, UB1 3HW, United Kingdom
Pfizer Investigational Site
Scunthorpe, North Lincolnshire, DN15 7BH, United Kingdom
Pfizer Investigational Site
Harrogate, North Yorkshire, HG2 7SX, United Kingdom
Pfizer Investigational Site
Northallerton, North Yorkshire, DL6 1JG, United Kingdom
Pfizer Investigational Site
Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom
Pfizer Investigational Site
Worksop, Nottinghamshire, S80 1HP, United Kingdom
Pfizer Investigational Site
Huthwaite, Nottingham, NG17 2LR, United Kingdom
Pfizer Investigational Site
Headington, Oxford, OX3 7LJ, United Kingdom
Pfizer Investigational Site
Haverfordwest, Pembrokeshire, SA61 1QX, United Kingdom
Pfizer Investigational Site
Haverfordwest, Pembrokeshire, SA61 2PZ, United Kingdom
Pfizer Investigational Site
Shrewsbury, Shropshire, SY3 8XG, United Kingdom
Pfizer Investigational Site
Frome, Somerset, BA11 1EZ, United Kingdom
Pfizer Investigational Site
Weston-super-Mare, Somerset, BS23 4TQ, United Kingdom
Pfizer Investigational Site
Sheffield, South Yorkshire, S5 7HD, United Kingdom
Pfizer Investigational Site
Sheffield, South Yorkshire, S5 7QB, United Kingdom
Pfizer Investigational Site
Sheffield, South Yorkshire, S7 2DW, United Kingdom
Pfizer Investigational Site
Stirling, Stirlingshire, FK8 2AU, United Kingdom
Pfizer Investigational Site
Carshalton, Surrey, SM5 1AA, United Kingdom
Pfizer Investigational Site
Epsom, Surrey, KT18 7EG, United Kingdom
Pfizer Investigational Site
Pontarddulais, Swansea, SA4 1TL, United Kingdom
Pfizer Investigational Site
Dundee, Tayside, DD1 9SY, United Kingdom
Pfizer Investigational Site
Dundee, Tayside, DD2 5NH, United Kingdom
Pfizer Investigational Site
Hetton-Le-Hole, Tyne & Wear, DH5 9EZ, United Kingdom
Pfizer Investigational Site
Gateshead, Tyne and Wear, NE9 6SX, United Kingdom
Pfizer Investigational Site
Nuneaton, Warwickshire, CV10 7DJ, United Kingdom
Pfizer Investigational Site
Rugby, Warwickshire, CV22 5PX, United Kingdom
Pfizer Investigational Site
Lyndon, West Bromwich, West Midlands, B71 4HJ, United Kingdom
Pfizer Investigational Site
Livingston, West Lothian, EH54 6PP, United Kingdom
Pfizer Investigational Site
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
Pfizer Investigational Site
Crawley, West Sussex, RH10 1LL, United Kingdom
Pfizer Investigational Site
Crawley, West Sussex, RH10 7DX, United Kingdom
Pfizer Investigational Site
Haywards Heath, West Sussex, RH16 4EX, United Kingdom
Pfizer Investigational Site
Corsham, Wiltshire, SN13 9DL, United Kingdom
Pfizer Investigational Site
Trowbridge, Wiltshire, BA14 7EG, United Kingdom
Pfizer Investigational Site
Trowbridge, Wiltshire, BA14 9AR, United Kingdom
Pfizer Investigational Site
Warminster, Wiltshire, BA14 9AA, United Kingdom
Pfizer Investigational Site
Westbury, Wiltshire, BA13 3JD, United Kingdom
Pfizer Investigational Site
York, Yorkshire, YO31 8HE, United Kingdom
Pfizer Investigational Site
Ayr, KA6 6DX, United Kingdom
Pfizer Investigational Site
Ayr, KA7 2AA, United Kingdom
Pfizer Investigational Site
Bath, BA1 2SR, United Kingdom
Pfizer Investigational Site
Bath, BA1 3NG, United Kingdom
Pfizer Investigational Site
Bath, BA2 1NH, United Kingdom
Pfizer Investigational Site
Bath, BA2 3HT, United Kingdom
Pfizer Investigational Site
Bath, BA2 4BY, United Kingdom
Pfizer Investigational Site
Belfast, BT12 6BA, United Kingdom
Pfizer Investigational Site
Belfast, BT14 6AB, United Kingdom
Pfizer Investigational Site
Belfast, BT9 7AB, United Kingdom
Pfizer Investigational Site
Birmingham, B15 2SQ, United Kingdom
Pfizer Investigational Site
Birmingham, B37 7TR, United Kingdom
Pfizer Investigational Site
Birmingham, B9 5SS, United Kingdom
Pfizer Investigational Site
Cambridge, CB2 2QQ, United Kingdom
Pfizer Investigational Site
Chippenham, Wiltshire, SN15 2SB, United Kingdom
Pfizer Investigational Site
Co. Dublin, United Kingdom
Pfizer Investigational Site
Coventry, CV1 4FH, United Kingdom
Pfizer Investigational Site
Derby, DE22 3DT, United Kingdom
Pfizer Investigational Site
Dewsbury, WF13 4HS, United Kingdom
Pfizer Investigational Site
Dublin, United Kingdom
Pfizer Investigational Site
Dumfries, DG1 4AP, United Kingdom
Pfizer Investigational Site
East Kilbride, G75 8RG, United Kingdom
Pfizer Investigational Site
Edinburgh, EH16 4SA, United Kingdom
Pfizer Investigational Site
Edinburgh, EH4 2XU, United Kingdom
Pfizer Investigational Site
Glasgow, G12 0YN, United Kingdom
Pfizer Investigational Site
Glasgow, G4 0SF, United Kingdom
Pfizer Investigational Site
Glasgow, G51 4TF, United Kingdom
Pfizer Investigational Site
Hartlepool, TS24 9AH, United Kingdom
Pfizer Investigational Site
Hertfordshire, AL7 4HQ, United Kingdom
Pfizer Investigational Site
Hertfordshire, SG1 4AB, United Kingdom
Pfizer Investigational Site
Inverness, IV2 3UJ, United Kingdom
Pfizer Investigational Site
Leicester, LE5 4PW, United Kingdom
Pfizer Investigational Site
Liverpool, L7 8XP, United Kingdom
Pfizer Investigational Site
Llantrisant, CF72 8XR, United Kingdom
Pfizer Investigational Site
London, N18 1QX, United Kingdom
Pfizer Investigational Site
London, NW3 2QG, United Kingdom
Pfizer Investigational Site
London, W12 0NN, United Kingdom
Pfizer Investigational Site
London, W6 8RF, United Kingdom
Pfizer Investigational Site
Manchester, M41 5SL, United Kingdom
Pfizer Investigational Site
Manchester, M6 8HD, United Kingdom
Pfizer Investigational Site
Manchester, M8 5RB, United Kingdom
Pfizer Investigational Site
Newcastle upon Tyne, NE4 6BE, United Kingdom
Pfizer Investigational Site
Nottingham, NG7 2UH, United Kingdom
Pfizer Investigational Site
Oldham, OL1 2JH, United Kingdom
Pfizer Investigational Site
Paisley, PA2 9PN, United Kingdom
Pfizer Investigational Site
Pontefract, WF8 1PL, United Kingdom
Pfizer Investigational Site
Southampton, SO14 0YG, United Kingdom
Pfizer Investigational Site
Swansea, SA1 1HW, United Kingdom
Pfizer Investigational Site
Swansea, SA1 4DF, United Kingdom
Pfizer Investigational Site
Wakefield, WF1 4DG, United Kingdom
Pfizer Investigational Site
Wigan, WN1 1XX, United Kingdom
Pfizer Investigational Site
Wiltshire, BA15 1DQ, United Kingdom
Pfizer Investigational Site
Wiltshire, SN12 7EA, United Kingdom
Pfizer Investigational Site
Wiltshire, SP2 8BJ, United Kingdom
Pfizer Investigational Site
Wishaw, ML2 0DP, United Kingdom
Related Publications (12)
Neil HA, DeMicco DA, Luo D, Betteridge DJ, Colhoun HM, Durrington PN, Livingstone SJ, Fuller JH, Hitman GA; CARDS Study Investigators. Analysis of efficacy and safety in patients aged 65-75 years at randomization: Collaborative Atorvastatin Diabetes Study (CARDS). Diabetes Care. 2006 Nov;29(11):2378-84. doi: 10.2337/dc06-0872.
PMID: 17065671RESULTTunnicliffe 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.
PMID: 38018702DERIVEDVogt L, Bangalore S, Fayyad R, Melamed S, Hovingh GK, DeMicco DA, Waters DD. Atorvastatin Has a Dose-Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double-Blind Randomized Controlled Trials. J Am Heart Assoc. 2019 May 7;8(9):e010827. doi: 10.1161/JAHA.118.010827.
PMID: 31020900DERIVEDBangalore S, Fayyad R, DeMicco DA, Colhoun HM, Waters DD. Body Weight Variability and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004724. doi: 10.1161/CIRCOUTCOMES.118.004724.
PMID: 30571333DERIVEDPorts 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.
PMID: 28573499DERIVEDDeedwania 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.
PMID: 27513651DERIVEDKaasenbrood L, Poulter NR, Sever PS, Colhoun HM, Livingstone SJ, Boekholdt SM, Pressel SL, Davis BR, van der Graaf Y, Visseren FL; CARDS, ALLHAT, and ASCOT Investigators. Development and Validation of a Model to Predict Absolute Vascular Risk Reduction by Moderate-Intensity Statin Therapy in Individual Patients With Type 2 Diabetes Mellitus: The Anglo Scandinavian Cardiac Outcomes Trial, Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, and Collaborative Atorvastatin Diabetes Study. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):213-21. doi: 10.1161/CIRCOUTCOMES.115.001980. Epub 2016 May 11.
PMID: 27174798DERIVEDSoedamah-Muthu SS, Livingstone SJ, Charlton-Menys V, Betteridge DJ, Hitman GA, Neil HA, Bao W, DeMicco DA, Preston GM, Fuller JH, Stehouwer CD, Schalkwijk CG, Durrington PN, Colhoun HM; CARDS Investigators. Effect of atorvastatin on C-reactive protein and benefits for cardiovascular disease in patients with type 2 diabetes: analyses from the Collaborative Atorvastatin Diabetes Trial. Diabetologia. 2015 Jul;58(7):1494-502. doi: 10.1007/s00125-015-3586-8. Epub 2015 Apr 22.
PMID: 25899452DERIVEDDeshmukh HA, Colhoun HM, Johnson T, McKeigue PM, Betteridge DJ, Durrington PN, Fuller JH, Livingstone S, Charlton-Menys V, Neil A, Poulter N, Sever P, Shields DC, Stanton AV, Chatterjee A, Hyde C, Calle RA, DeMicco DA, Trompet S, Postmus I, Ford I, Jukema JW, Caulfield M, Hitman GA. Genome-wide association study of genetic determinants of LDL-c response to atorvastatin therapy: importance of Lp(a). J Lipid Res. 2012 May;53(5):1000-1011. doi: 10.1194/jlr.P021113. Epub 2012 Feb 24.
PMID: 22368281DERIVEDColhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil HA, Livingstone SJ, Charlton-Menys V, DeMicco DA, Fuller JH; CARDS Investigators. Effects of atorvastatin on kidney outcomes and cardiovascular disease in patients with diabetes: an analysis from the Collaborative Atorvastatin Diabetes Study (CARDS). Am J Kidney Dis. 2009 Nov;54(5):810-9. doi: 10.1053/j.ajkd.2009.03.022. Epub 2009 Jun 21.
PMID: 19540640DERIVEDCharlton-Menys V, Betteridge DJ, Colhoun H, Fuller J, France M, Hitman GA, Livingstone SJ, Neil HA, Newman CB, Szarek M, DeMicco DA, Durrington PN. Apolipoproteins, cardiovascular risk and statin response in type 2 diabetes: the Collaborative Atorvastatin Diabetes Study (CARDS). Diabetologia. 2009 Feb;52(2):218-25. doi: 10.1007/s00125-008-1176-8. Epub 2008 Oct 30.
PMID: 18972097DERIVEDNewman CB, Szarek M, Colhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil HA, Demicco DA, Auster S, Fuller JH; Cards Investigators. The safety and tolerability of atorvastatin 10 mg in the Collaborative Atorvastatin Diabetes Study (CARDS). Diab Vasc Dis Res. 2008 Sep;5(3):177-83. doi: 10.3132/dvdr.2008.029.
PMID: 18777490DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 16, 2006
First Posted
May 18, 2006
Study Start
January 1, 1997
Study Completion
February 1, 2004
Last Updated
May 10, 2007
Record last verified: 2007-05