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)

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.

Study Overview

• Status: Completed
• Conditions: Angina, Unstable; Cerebrovascular Accident; Coronary Artery Bypass Graft; Revascularization; Major Coronary Event
• Intervention / Treatment: Drug: Atorvastatin

• Study Type: Interventional
• Enrollment: 2800
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Ayr, United Kingdom, KA6 6DX
    • Pfizer Investigational Site
  • Ayr, United Kingdom, KA7 2AA
    • Pfizer Investigational Site
  • Bath, United Kingdom, BA2 3HT
    • Pfizer Investigational Site
  • Bath, United Kingdom, BA2 4BY
    • Pfizer Investigational Site
  • Bath, United Kingdom, BA1 2SR
    • Pfizer Investigational Site
  • Bath, United Kingdom, BA1 3NG
    • Pfizer Investigational Site
  • Bath, United Kingdom, BA2 1NH
    • Pfizer Investigational Site
  • Belfast, United Kingdom, BT9 7AB
    • Pfizer Investigational Site
  • Belfast, United Kingdom, BT12 6BA
    • Pfizer Investigational Site
  • Belfast, United Kingdom, BT14 6AB
    • Pfizer Investigational Site
  • Birmingham, United Kingdom, B37 7TR
    • Pfizer Investigational Site
  • Birmingham, United Kingdom, B9 5SS
    • Pfizer Investigational Site
  • Birmingham, United Kingdom, B15 2SQ
    • Pfizer Investigational Site
  • Cambridge, United Kingdom, CB2 2QQ
    • Pfizer Investigational Site
  • Chippenham, Wiltshire, United Kingdom, SN15 2SB
    • Pfizer Investigational Site
  • Co. Dublin, United Kingdom
    • Pfizer Investigational Site
  • Coventry, United Kingdom, CV1 4FH
    • Pfizer Investigational Site
  • Derby, United Kingdom, DE22 3DT
    • Pfizer Investigational Site
  • Dewsbury, United Kingdom, WF13 4HS
    • Pfizer Investigational Site
  • Dublin 8, United Kingdom
    • Pfizer Investigational Site
  • Dumfries, United Kingdom, DG1 4AP
    • Pfizer Investigational Site
  • East Kilbride, United Kingdom, G75 8RG
    • Pfizer Investigational Site
  • Edinburgh, United Kingdom, EH4 2XU
    • Pfizer Investigational Site
  • Edinburgh, United Kingdom, EH16 4SA
    • Pfizer Investigational Site
  • Glasgow, United Kingdom, G12 0YN
    • Pfizer Investigational Site
  • Glasgow, United Kingdom, G4 0SF
    • Pfizer Investigational Site
  • Glasgow, United Kingdom, G51 4TF
    • Pfizer Investigational Site
  • Hartlepool, United Kingdom, TS24 9AH
    • Pfizer Investigational Site
  • Hertfordshire, United Kingdom, AL7 4HQ
    • Pfizer Investigational Site
  • Hertfordshire, United Kingdom, SG1 4AB
    • Pfizer Investigational Site
  • Inverness, United Kingdom, IV2 3UJ
    • Pfizer Investigational Site
  • Leicester, United Kingdom, LE5 4PW
    • Pfizer Investigational Site
  • Liverpool, United Kingdom, L7 8XP
    • Pfizer Investigational Site
  • Llantrisant, United Kingdom, CF72 8XR
    • Pfizer Investigational Site
  • London, United Kingdom, W6 8RF
    • Pfizer Investigational Site
  • London, United Kingdom, NW3 2QG
    • Pfizer Investigational Site
  • London, United Kingdom, N18 1QX
    • Pfizer Investigational Site
  • London, United Kingdom, W12 0NN
    • Pfizer Investigational Site
  • Manchester, United Kingdom, M8 5RB
    • Pfizer Investigational Site
  • Manchester, United Kingdom, M41 5SL
    • Pfizer Investigational Site
  • Manchester, United Kingdom, M6 8HD
    • Pfizer Investigational Site
  • Newcastle upon Tyne, United Kingdom, NE4 6BE
    • Pfizer Investigational Site
  • Nottingham, United Kingdom, NG7 2UH
    • Pfizer Investigational Site
  • Oldham, United Kingdom, OL1 2JH
    • Pfizer Investigational Site
  • Paisley, United Kingdom, PA2 9PN
    • Pfizer Investigational Site
  • Pontefract, United Kingdom, WF8 1PL
    • Pfizer Investigational Site
  • Southampton, United Kingdom, SO14 0YG
    • Pfizer Investigational Site
  • Swansea, United Kingdom, SA1 1HW
    • Pfizer Investigational Site
  • Swansea, United Kingdom, SA1 4DF
    • Pfizer Investigational Site
  • Wakefield, United Kingdom, WF1 4DG
    • Pfizer Investigational Site
  • Wigan, United Kingdom, WN1 1XX
    • Pfizer Investigational Site
  • Wiltshire, United Kingdom, BA15 1DQ
    • Pfizer Investigational Site
  • Wiltshire, United Kingdom, SN12 7EA
    • Pfizer Investigational Site
  • Wiltshire, United Kingdom, SP2 8BJ
    • Pfizer Investigational Site
  • Wishaw, United Kingdom, ML2 0DP
    • Pfizer Investigational Site
  • Aberdeen
    • Fosterhill, Aberdeen, United Kingdom, AB25 2XG
      • Pfizer Investigational Site
  • Ayrshire
    • Irvine, Ayrshire, United Kingdom, KA12 0AY
      • Pfizer Investigational Site
  • Bath
    • Midsomer Norton, Bath, United Kingdom, BA3 2UH
      • Pfizer Investigational Site
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG2 7AG
      • Pfizer Investigational Site
    • Slough, Berkshire, United Kingdom, SL1 2AD
      • Pfizer Investigational Site
  • Berskhire
    • Maidenhead, Berskhire, United Kingdom, SL6 6EL
      • Pfizer Investigational Site
  • Birmingham
    • Edgbaston, Birmingham, United Kingdom, B15 2TH
      • Pfizer Investigational Site
  • Bristol
    • Frenchay, Bristol, United Kingdom, BS16 1LE
      • Pfizer Investigational Site
  • Cardiff
    • Llanishen, Cardiff, United Kingdom, CF14 5GJ
      • Pfizer Investigational Site
  • Clwydd
    • Wrexham, Clwydd, United Kingdom, LL13 7TD
      • Pfizer Investigational Site
  • Cornwall
    • Bocastle, Cornwall, United Kingdom, PL35 0BG
      • Pfizer Investigational Site
    • Falmouth, Cornwall, United Kingdom, TR11 2LH
      • Pfizer Investigational Site
    • Fowey, Cornwall, United Kingdom, PL23 1DT
      • Pfizer Investigational Site
    • Penzance, Cornwall, United Kingdom, TR18 4JH
      • Pfizer Investigational Site
    • Penzance, Cornwall, United Kingdom, TR19 7HX
      • Pfizer Investigational Site
    • Redruth, Cornwall, United Kingdom, TR15 2LL
      • Pfizer Investigational Site
    • Saltash, Cornwall, United Kingdom, PL12 6DL
      • Pfizer Investigational Site
    • St. Austell, Cornwall, United Kingdom, PL26 7RL
      • Pfizer Investigational Site
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • Pfizer Investigational Site
  • Derbyshire
    • Chesterfield, Derbyshire, United Kingdom, S40 4TF
      • Pfizer Investigational Site
  • Devon
    • Crownhill, Plymouth, Devon, United Kingdom, PL5 3JB
      • Pfizer Investigational Site
    • Plymouth, Devon, United Kingdom, PL6 7TH
      • Pfizer Investigational Site
    • Plympton, Devon, United Kingdom, PL7 1AD
      • Pfizer Investigational Site
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH8 9EW
      • Pfizer Investigational Site
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Pfizer Investigational Site
  • Essex
    • Epping, Essex, United Kingdom, CM16 6TN
      • Pfizer Investigational Site
    • Southend on Sea, Essex, United Kingdom, SS1 2AB
      • Pfizer Investigational Site
  • Glasgow
    • Langside, Glasgow, United Kingdom, G42 9TY
      • Pfizer Investigational Site
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Pfizer Investigational Site
    • Southampton, Hampshire, United Kingdom, SO31 7DQ
      • Pfizer Investigational Site
    • Titchfield, Hampshire, United Kingdom, PO14 4EH
      • Pfizer Investigational Site
  • Hertfordshire
    • Hemel Hempstead, Hertfordshire, United Kingdom, HP2 4AD
      • Pfizer Investigational Site
    • Watford, Hertfordshire, United Kingdom, WD18 0HB
      • Pfizer Investigational Site
  • Isle of Wight
    • Ryde, Isle of Wight, United Kingdom, PO33 2EH
      • Pfizer Investigational Site
  • Kent
    • Gillingham, Kent, United Kingdom, ME7 5NY
      • Pfizer Investigational Site
    • Hildenborough, Kent, United Kingdom, TN11 9HL
      • Pfizer Investigational Site
    • Tunbridge Wells, Kent, United Kingdom, TN1 2DX
      • Pfizer Investigational Site
  • Lancashire
    • Bolton, Lancashire, United Kingdom, BL4 0JR
      • Pfizer Investigational Site
    • Ormskirk, Lancashire, United Kingdom, L39 2AZ
      • Pfizer Investigational Site
  • Liverpool
    • Waterloo, Liverpool, United Kingdom, L22 0LG
      • Pfizer Investigational Site
  • M15 6sx
    • Manchester, M15 6sx, United Kingdom
      • Pfizer Investigational Site
  • Middlesex
    • Ashford, Middlesex, United Kingdom, TW15 2TU
      • Pfizer Investigational Site
    • Southall, Middlesex, United Kingdom, UB1 3HW
      • Pfizer Investigational Site
  • North Lincolnshire
    • Scunthorpe, North Lincolnshire, United Kingdom, DN15 7BH
      • Pfizer Investigational Site
  • North Yorkshire
    • Harrogate, North Yorkshire, United Kingdom, HG2 7SX
      • Pfizer Investigational Site
    • Northallerton, North Yorkshire, United Kingdom, DL6 1JG
      • Pfizer Investigational Site
  • Nottingham
    • Huthwaite, Nottingham, United Kingdom, NG17 2LR
      • Pfizer Investigational Site
  • Nottinghamshire
    • Sutton-in-Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
      • Pfizer Investigational Site
    • Worksop, Nottinghamshire, United Kingdom, S80 1HP
      • Pfizer Investigational Site
  • Oxford
    • Headington, Oxford, United Kingdom, OX3 7LJ
      • Pfizer Investigational Site
  • Pembrokeshire
    • Haverfordwest, Pembrokeshire, United Kingdom, SA61 1QX
      • Pfizer Investigational Site
    • Haverfordwest, Pembrokeshire, United Kingdom, SA61 2PZ
      • Pfizer Investigational Site
  • Shropshire
    • Shrewsbury, Shropshire, United Kingdom, SY3 8XG
      • Pfizer Investigational Site
  • Somerset
    • Frome, Somerset, United Kingdom, BA11 1EZ
      • Pfizer Investigational Site
    • Weston-Super-Mare, Somerset, United Kingdom, BS23 4TQ
      • Pfizer Investigational Site
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S5 7HD
      • Pfizer Investigational Site
    • Sheffield, South Yorkshire, United Kingdom, S5 7QB
      • Pfizer Investigational Site
    • Sheffield, South Yorkshire, United Kingdom, S7 2DW
      • Pfizer Investigational Site
  • Stirlingshire
    • Stirling, Stirlingshire, United Kingdom, FK8 2AU
      • Pfizer Investigational Site
  • Surrey
    • Carshalton, Surrey, United Kingdom, SM5 1AA
      • Pfizer Investigational Site
    • Epsom, Surrey, United Kingdom, KT18 7EG
      • Pfizer Investigational Site
  • Swansea
    • Pontarddulais, Swansea, United Kingdom, SA4 1TL
      • Pfizer Investigational Site
  • Tayside
    • Dundee, Tayside, United Kingdom, DD1 9SY
      • Pfizer Investigational Site
    • Dundee, Tayside, United Kingdom, DD2 5NH
      • Pfizer Investigational Site
  • Tyne & Wear
    • Hetton le Hole, Tyne & Wear, United Kingdom, DH5 9EZ
      • Pfizer Investigational Site
  • Tyne and Wear
    • Gateshead, Tyne and Wear, United Kingdom, NE9 6SX
      • Pfizer Investigational Site
  • Warwickshire
    • Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
      • Pfizer Investigational Site
    • Rugby, Warwickshire, United Kingdom, CV22 5PX
      • Pfizer Investigational Site
  • West Bromwich, West Midlands
    • Lyndon, West Bromwich, West Midlands, United Kingdom, B71 4HJ
      • Pfizer Investigational Site
  • West Lothian
    • Livingston, West Lothian, United Kingdom, EH54 6PP
      • Pfizer Investigational Site
  • West Midlands
    • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
      • Pfizer Investigational Site
  • West Sussex
    • Crawley, West Sussex, United Kingdom, RH10 1LL
      • Pfizer Investigational Site
    • Crawley, West Sussex, United Kingdom, RH10 7DX
      • Pfizer Investigational Site
    • Haywards Heath, West Sussex, United Kingdom, RH16 4EX
      • Pfizer Investigational Site
  • Wiltshire
    • Corsham, Wiltshire, United Kingdom, SN13 9DL
      • Pfizer Investigational Site
    • Trowbridge, Wiltshire, United Kingdom, BA14 9AR
      • Pfizer Investigational Site
    • Trowbridge, Wiltshire, United Kingdom, BA14 7EG
      • Pfizer Investigational Site
    • Warminster, Wiltshire, United Kingdom, BA14 9AA
      • Pfizer Investigational Site
    • Westbury, Wiltshire, United Kingdom, BA13 3JD
      • Pfizer Investigational Site
  • Yorkshire
    • York, Yorkshire, United Kingdom, YO31 8HE
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Type I Diabetes Mellitus
• Any major Coronary event prior to entry into the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Diabetes UK; Department of Health, United Kingdom

Publications and helpful links

General Publications

• Vogt 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.
• Bangalore 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.
• 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.
• 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.
• Kaasenbrood 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.
• 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.
• Soedamah-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.
• Deshmukh 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.
• Colhoun 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.
• Charlton-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. Erratum In: Diabetologia. 2009 Mar;52(3):556.
• Newman 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 1997
• Study Completion: February 1, 2004

Study Registration Dates

• First Submitted: May 16, 2006
• First Submitted That Met QC Criteria: May 16, 2006
• First Posted (Estimate): May 18, 2006

Study Record Updates

• Last Update Posted (Estimate): May 10, 2007
• Last Update Submitted That Met QC Criteria: May 8, 2007
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Stroke; Angina, Unstable; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 0981-430-102; A2581143