Major Coronary EventPhase 4CARDSNCT00327418
CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events
A Phase 4 study testing Atorvastatin in people with Major Coronary Event and Cerebrovascular Accident, run by Pfizer at 135 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Major Coronary Event, Cerebrovascular Accident, Coronary Artery Bypass Graft
- What is being tested?
- Atorvastatin
- How many people
- 2,800 participants
- Where
- 135 sitesUnited Kingdom
- Study dates
- Jan 1997to Feb 2004
- Phase
- Phase 4
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Type I Diabetes Mellitus
- Any major Coronary event prior to entry into the study
Trial locations and contacts
135 sites in 1 country.
135 sites in 1 country
United Kingdom135 sites
Pfizer Investigational Site
Ashford, Middlesex, TW15 2TU
Pfizer Investigational Site
Ayr, KA6 6DX
Pfizer Investigational Site
Ayr, KA7 2AA
Pfizer Investigational Site
Bath, BA1 2SR
Pfizer Investigational Site
Bath, BA1 3NG
Pfizer Investigational Site
Bath, BA2 1NH
Pfizer Investigational Site
Bath, BA2 3HT
Pfizer Investigational Site
Bath, BA2 4BY
Pfizer Investigational Site
Belfast, BT12 6BA
Pfizer Investigational Site
Belfast, BT14 6AB
Pfizer Investigational Site
Belfast, BT9 7AB
Pfizer Investigational Site
Birmingham, B15 2SQ
Pfizer Investigational Site
Birmingham, B37 7TR
Pfizer Investigational Site
Birmingham, B9 5SS
Pfizer Investigational Site
Bocastle, Cornwall, PL35 0BG
Pfizer Investigational Site
Bolton, Lancashire, BL4 0JR
Pfizer Investigational Site
Bournemouth, Dorset, BH7 7DW
Pfizer Investigational Site
Bournemouth, Dorset, BH8 9EW
Pfizer Investigational Site
Cambridge, CB2 2QQ
Pfizer Investigational Site
Carshalton, Surrey, SM5 1AA
Pfizer Investigational Site
Chesterfield, Derbyshire, S40 4TF
Pfizer Investigational Site
Chippenham, Wiltshire, SN15 2SB
Pfizer Investigational Site
Co. Dublin
Pfizer Investigational Site
Corsham, Wiltshire, SN13 9DL
Pfizer Investigational Site
Coventry, CV1 4FH
Pfizer Investigational Site
Crawley, West Sussex, RH10 1LL
Pfizer Investigational Site
Crawley, West Sussex, RH10 7DX
Pfizer Investigational Site
Crownhill, Plymouth, DEVON, PL5 3JB
Pfizer Investigational Site
Derby, DE22 3DT
Pfizer Investigational Site
Dewsbury, WF13 4HS
Pfizer Investigational Site
Dublin
Pfizer Investigational Site
Dumfries, DG1 4AP
Pfizer Investigational Site
Dundee, Tayside, DD1 9SY
Pfizer Investigational Site
Dundee, Tayside, DD2 5NH
Pfizer Investigational Site
East Kilbride, G75 8RG
Pfizer Investigational Site
Edgbaston, Birmingham, B15 2TH
Pfizer Investigational Site
Edinburgh, EH16 4SA
Pfizer Investigational Site
Edinburgh, EH4 2XU
Pfizer Investigational Site
Epping, Essex, CM16 6TN
Pfizer Investigational Site
Epsom, Surrey, KT18 7EG
Pfizer Investigational Site
Falmouth, Cornwall, TR11 2LH
Pfizer Investigational Site
Fosterhill, Aberdeen, AB25 2XG
Pfizer Investigational Site
Fowey, Cornwall, PL23 1DT
Pfizer Investigational Site
Frenchay, Bristol, BS16 1LE
Pfizer Investigational Site
Frome, Somerset, BA11 1EZ
Pfizer Investigational Site
Gateshead, Tyne and Wear, NE9 6SX
Pfizer Investigational Site
Gillingham, Kent, ME7 5NY
Pfizer Investigational Site
Glasgow, G12 0YN
Pfizer Investigational Site
Glasgow, G4 0SF
Pfizer Investigational Site
Glasgow, G51 4TF
Pfizer Investigational Site
Harrogate, North Yorkshire, HG2 7SX
Pfizer Investigational Site
Hartlepool, TS24 9AH
Pfizer Investigational Site
Haverfordwest, Pembrokeshire, SA61 1QX
Pfizer Investigational Site
Haverfordwest, Pembrokeshire, SA61 2PZ
Pfizer Investigational Site
Haywards Heath, West Sussex, RH16 4EX
Pfizer Investigational Site
Headington, Oxford, OX3 7LJ
Pfizer Investigational Site
Hemel Hempstead, Hertfordshire, HP2 4AD
Pfizer Investigational Site
Hertfordshire, AL7 4HQ
Pfizer Investigational Site
Hertfordshire, SG1 4AB
Pfizer Investigational Site
Hetton-Le-Hole, Tyne & Wear, DH5 9EZ
Pfizer Investigational Site
Hildenborough, Kent, TN11 9HL
Pfizer Investigational Site
Huthwaite, Nottingham, NG17 2LR
Pfizer Investigational Site
Inverness, IV2 3UJ
Pfizer Investigational Site
Irvine, Ayrshire, KA12 0AY
Pfizer Investigational Site
Langside, Glasgow, G42 9TY
Pfizer Investigational Site
Leicester, LE5 4PW
Pfizer Investigational Site
Liverpool, L7 8XP
Pfizer Investigational Site
Livingston, West Lothian, EH54 6PP
Pfizer Investigational Site
Llanishen, Cardiff, CF14 5GJ
Pfizer Investigational Site
Llantrisant, CF72 8XR
Pfizer Investigational Site
London, N18 1QX
Pfizer Investigational Site
London, NW3 2QG
Pfizer Investigational Site
London, W12 0NN
Pfizer Investigational Site
London, W6 8RF
Pfizer Investigational Site
Lyndon, West Bromwich, West Midlands, B71 4HJ
Pfizer Investigational Site
Maidenhead, Berskhire, SL6 6EL
Pfizer Investigational Site
Manchester, M15 6SX
Pfizer Investigational Site
Manchester, M41 5SL
Pfizer Investigational Site
Manchester, M6 8HD
Pfizer Investigational Site
Manchester, M8 5RB
Pfizer Investigational Site
Midsomer Norton, Bath, BA3 2UH
Pfizer Investigational Site
Newcastle upon Tyne, NE4 6BE
Pfizer Investigational Site
Northallerton, North Yorkshire, DL6 1JG
Pfizer Investigational Site
Nottingham, NG7 2UH
Pfizer Investigational Site
Nuneaton, Warwickshire, CV10 7DJ
Pfizer Investigational Site
Oldham, OL1 2JH
Pfizer Investigational Site
Ormskirk, Lancashire, L39 2AZ
Pfizer Investigational Site
Paisley, PA2 9PN
Pfizer Investigational Site
Penzance, CORNWALL, TR18 4JH
Pfizer Investigational Site
Penzance, Cornwall, TR19 7HX
Pfizer Investigational Site
Plymouth, Devon, PL6 7TH
Pfizer Investigational Site
Plympton, Devon, PL7 1AD
Pfizer Investigational Site
Pontarddulais, Swansea, SA4 1TL
Pfizer Investigational Site
Pontefract, WF8 1PL
Pfizer Investigational Site
Portsmouth, Hampshire, PO6 3LY
Pfizer Investigational Site
Reading, Berkshire, RG2 7AG
Pfizer Investigational Site
Redruth, Cornwall, TR15 2LL
Pfizer Investigational Site
Royal Tunbridge Wells, Kent, TN1 2DX
Pfizer Investigational Site
Rugby, Warwickshire, CV22 5PX
Pfizer Investigational Site
Ryde, Isle of Wight, PO33 2EH
Pfizer Investigational Site
Saltash, CORNWALL, PL12 6DL
Pfizer Investigational Site
Scunthorpe, North Lincolnshire, DN15 7BH
Pfizer Investigational Site
Sheffield, South Yorkshire, S5 7HD
Pfizer Investigational Site
Sheffield, South Yorkshire, S5 7QB
Pfizer Investigational Site
Sheffield, South Yorkshire, S7 2DW
Pfizer Investigational Site
Shrewsbury, Shropshire, SY3 8XG
Pfizer Investigational Site
Slough, Berkshire, SL1 2AD
Pfizer Investigational Site
Southall, Middlesex, UB1 3HW
Pfizer Investigational Site
Southampton, Hampshire, SO31 7DQ
Pfizer Investigational Site
Southampton, SO14 0YG
Pfizer Investigational Site
Southend-on-Sea, Essex, SS1 2AB
Pfizer Investigational Site
St Austell, Cornwall, PL26 7RL
Pfizer Investigational Site
Stirling, Stirlingshire, FK8 2AU
Pfizer Investigational Site
Sutton in Ashfield, Nottinghamshire, NG17 4JL
Pfizer Investigational Site
Swansea, SA1 1HW
Pfizer Investigational Site
Swansea, SA1 4DF
Pfizer Investigational Site
Titchfield, Hampshire, PO14 4EH
Pfizer Investigational Site
Trowbridge, Wiltshire, BA14 7EG
Pfizer Investigational Site
Trowbridge, Wiltshire, BA14 9AR
Pfizer Investigational Site
Truro, Cornwall, TR1 3LJ
Pfizer Investigational Site
Wakefield, WF1 4DG
Pfizer Investigational Site
Warminster, Wiltshire, BA14 9AA
Pfizer Investigational Site
Waterloo, Liverpool, L22 0LG
Pfizer Investigational Site
Watford, Hertfordshire, WD18 0HB
Pfizer Investigational Site
Westbury, Wiltshire, BA13 3JD
Pfizer Investigational Site
Weston-super-Mare, Somerset, BS23 4TQ
Pfizer Investigational Site
Wigan, WN1 1XX
Pfizer Investigational Site
Wiltshire, BA15 1DQ
Pfizer Investigational Site
Wiltshire, SN12 7EA
Pfizer Investigational Site
Wiltshire, SP2 8BJ
Pfizer Investigational Site
Wishaw, ML2 0DP
Pfizer Investigational Site
Wolverhampton, West Midlands, WV10 0QP
Pfizer Investigational Site
Worksop, Nottinghamshire, S80 1HP
Pfizer Investigational Site
Wrexham, Clwydd, LL13 7TD
Pfizer Investigational Site
York, Yorkshire, YO31 8HE
About this study
Official title: 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.
- Conditions
- Major Coronary Event, Cerebrovascular Accident, Coronary Artery Bypass Graft, Angina, Unstable, Revascularization
- Being tested
- Atorvastatin
- Medical subject headings
- Stroke, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startJan 1997
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Major Coronary EventStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 2,800 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Diabetes UK, Department of Health, United Kingdom
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327418
- Sponsor's protocol ID
- 0981-430-102
- Other IDs
- A2581143
- Acronym
- CARDS
- Status last verified
- May 2007
- First submitted
- 16 May 2006
- Last updated
- 10 May 2007
- Results posted
- No
Publications
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.
PubMed 17065671Tunnicliffe 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 38018702Vogt 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.
PubMed 31020900Bangalore 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.
PubMed 30571333Ports 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 28573499Deedwania 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 27513651Kaasenbrood 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.
PubMed 27174798Soedamah-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.
PubMed 25899452Deshmukh 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.
PubMed 22368281Colhoun 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.
PubMed 19540640Charlton-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.
PubMed 18972097Newman 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.
PubMed 18777490