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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.

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

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
What is being tested?
Atorvastatin
How many people
2,800 participants
Where
135 sitesUnited Kingdom
Study dates
Jan 1997to Feb 2004
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 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

Other trials in United Kingdom

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.

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.

What is being measured

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

  1. Time from randomization to the occurrence of a primary clinical endpoint

  2. i.e. major coronary event or CABG or other coronary revascularization procedure

  3. or unstable angina or resuscitated cardiac arrest or stroke.

Secondary outcomes (4)

  1. The incidence rate of a primary clinical and endpoint; the time from randomization

  2. to the occurrence of and the incidence rate of other parameters e.g. total

  3. mortality, any cardiovascular event, new PVD etc. and the percent change from

  4. 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.

  1. First posted18 May 2006 (estimated)
  2. Study startJan 1997
  3. Study completionFeb 2004

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
2,800 participants
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 17065671

  • 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

  • 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.

    PubMed 31020900

  • 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.

    PubMed 30571333

  • 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

  • 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

  • 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.

    PubMed 27174798

  • 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.

    PubMed 25899452

  • 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.

    PubMed 22368281

  • 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.

    PubMed 19540640

  • 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.

    PubMed 18972097

  • 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.

    PubMed 18777490

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atorvastatin in people with Major Coronary Event and Cerebrovascular Accident, run by Pfizer at 135 sites in United Kingdom.

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 6 inclusion and 2 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 10 May 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United Kingdom. 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 from randomization to the occurrence of a primary clinical endpoint. The study lists 3 primary outcomes in all. 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 NCT00327418, which also lists 12 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 10 May 2007.

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