Cerebrovascular Accident Clinical Trial
— CARDSOfficial 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)
| Verified date | May 2007 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 2800 |
| Est. completion date | February 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Pfizer Investigational Site | Ashford | Middlesex |
| United Kingdom | Pfizer Investigational Site | Ayr | |
| United Kingdom | Pfizer Investigational Site | Ayr | |
| United Kingdom | Pfizer Investigational Site | Bath | |
| United Kingdom | Pfizer Investigational Site | Bath | |
| United Kingdom | Pfizer Investigational Site | Bath | |
| United Kingdom | Pfizer Investigational Site | Bath | |
| United Kingdom | Pfizer Investigational Site | Bath | |
| United Kingdom | Pfizer Investigational Site | Belfast | |
| United Kingdom | Pfizer Investigational Site | Belfast | |
| United Kingdom | Pfizer Investigational Site | Belfast | |
| United Kingdom | Pfizer Investigational Site | Birmingham | |
| United Kingdom | Pfizer Investigational Site | Birmingham | |
| United Kingdom | Pfizer Investigational Site | Birmingham | |
| United Kingdom | Pfizer Investigational Site | Bocastle | Cornwall |
| United Kingdom | Pfizer Investigational Site | Bolton | Lancashire |
| United Kingdom | Pfizer Investigational Site | Bournemouth | Dorset |
| United Kingdom | Pfizer Investigational Site | Bournemouth | Dorset |
| United Kingdom | Pfizer Investigational Site | Cambridge | |
| United Kingdom | Pfizer Investigational Site | Carshalton | Surrey |
| United Kingdom | Pfizer Investigational Site | Chesterfield | Derbyshire |
| United Kingdom | Pfizer Investigational Site | Chippenham, Wiltshire | |
| United Kingdom | Pfizer Investigational Site | Co. Dublin | |
| United Kingdom | Pfizer Investigational Site | Corsham | Wiltshire |
| United Kingdom | Pfizer Investigational Site | Coventry | |
| United Kingdom | Pfizer Investigational Site | Crawley | West Sussex |
| United Kingdom | Pfizer Investigational Site | Crawley | West Sussex |
| United Kingdom | Pfizer Investigational Site | Crownhill, Plymouth | Devon |
| United Kingdom | Pfizer Investigational Site | Derby | |
| United Kingdom | Pfizer Investigational Site | Dewsbury | |
| United Kingdom | Pfizer Investigational Site | Dublin 8 | |
| United Kingdom | Pfizer Investigational Site | Dumfries | |
| United Kingdom | Pfizer Investigational Site | Dundee | Tayside |
| United Kingdom | Pfizer Investigational Site | Dundee | Tayside |
| United Kingdom | Pfizer Investigational Site | East Kilbride | |
| United Kingdom | Pfizer Investigational Site | Edgbaston | Birmingham |
| United Kingdom | Pfizer Investigational Site | Edinburgh | |
| United Kingdom | Pfizer Investigational Site | Edinburgh | |
| United Kingdom | Pfizer Investigational Site | Epping | Essex |
| United Kingdom | Pfizer Investigational Site | Epsom | Surrey |
| United Kingdom | Pfizer Investigational Site | Falmouth | Cornwall |
| United Kingdom | Pfizer Investigational Site | Fosterhill | Aberdeen |
| United Kingdom | Pfizer Investigational Site | Fowey | Cornwall |
| United Kingdom | Pfizer Investigational Site | Frenchay | Bristol |
| United Kingdom | Pfizer Investigational Site | Frome | Somerset |
| United Kingdom | Pfizer Investigational Site | Gateshead | Tyne and Wear |
| United Kingdom | Pfizer Investigational Site | Gillingham | Kent |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Harrogate | North Yorkshire |
| United Kingdom | Pfizer Investigational Site | Hartlepool | |
| United Kingdom | Pfizer Investigational Site | Haverfordwest | Pembrokeshire |
| United Kingdom | Pfizer Investigational Site | Haverfordwest | Pembrokeshire |
| United Kingdom | Pfizer Investigational Site | Haywards Heath | West Sussex |
| United Kingdom | Pfizer Investigational Site | Headington | Oxford |
| United Kingdom | Pfizer Investigational Site | Hemel Hempstead | Hertfordshire |
| United Kingdom | Pfizer Investigational Site | Hertfordshire | |
| United Kingdom | Pfizer Investigational Site | Hertfordshire | |
| United Kingdom | Pfizer Investigational Site | Hetton le Hole | Tyne & Wear |
| United Kingdom | Pfizer Investigational Site | Hildenborough | Kent |
| United Kingdom | Pfizer Investigational Site | Huthwaite | Nottingham |
| United Kingdom | Pfizer Investigational Site | Inverness | |
| United Kingdom | Pfizer Investigational Site | Irvine | Ayrshire |
| United Kingdom | Pfizer Investigational Site | Langside | Glasgow |
| United Kingdom | Pfizer Investigational Site | Leicester | |
| United Kingdom | Pfizer Investigational Site | Liverpool | |
| United Kingdom | Pfizer Investigational Site | Livingston | West Lothian |
| United Kingdom | Pfizer Investigational Site | Llanishen | Cardiff |
| United Kingdom | Pfizer Investigational Site | Llantrisant | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | Lyndon | West Bromwich, West Midlands |
| United Kingdom | Pfizer Investigational Site | Maidenhead | Berskhire |
| United Kingdom | Pfizer Investigational Site | Manchester | M15 6sx |
| United Kingdom | Pfizer Investigational Site | Manchester | |
| United Kingdom | Pfizer Investigational Site | Manchester | |
| United Kingdom | Pfizer Investigational Site | Manchester | |
| United Kingdom | Pfizer Investigational Site | Midsomer Norton | Bath |
| United Kingdom | Pfizer Investigational Site | Newcastle upon Tyne | |
| United Kingdom | Pfizer Investigational Site | Northallerton | North Yorkshire |
| United Kingdom | Pfizer Investigational Site | Nottingham | |
| United Kingdom | Pfizer Investigational Site | Nuneaton | Warwickshire |
| United Kingdom | Pfizer Investigational Site | Oldham | |
| United Kingdom | Pfizer Investigational Site | Ormskirk | Lancashire |
| United Kingdom | Pfizer Investigational Site | Paisley | |
| United Kingdom | Pfizer Investigational Site | Penzance | Cornwall |
| United Kingdom | Pfizer Investigational Site | Penzance | Cornwall |
| United Kingdom | Pfizer Investigational Site | Plymouth | Devon |
| United Kingdom | Pfizer Investigational Site | Plympton | Devon |
| United Kingdom | Pfizer Investigational Site | Pontarddulais | Swansea |
| United Kingdom | Pfizer Investigational Site | Pontefract | |
| United Kingdom | Pfizer Investigational Site | Portsmouth | Hampshire |
| United Kingdom | Pfizer Investigational Site | Reading | Berkshire |
| United Kingdom | Pfizer Investigational Site | Redruth | Cornwall |
| United Kingdom | Pfizer Investigational Site | Rugby | Warwickshire |
| United Kingdom | Pfizer Investigational Site | Ryde | Isle of Wight |
| United Kingdom | Pfizer Investigational Site | Saltash | Cornwall |
| United Kingdom | Pfizer Investigational Site | Scunthorpe | North Lincolnshire |
| United Kingdom | Pfizer Investigational Site | Sheffield | South Yorkshire |
| United Kingdom | Pfizer Investigational Site | Sheffield | South Yorkshire |
| United Kingdom | Pfizer Investigational Site | Sheffield | South Yorkshire |
| United Kingdom | Pfizer Investigational Site | Shrewsbury | Shropshire |
| United Kingdom | Pfizer Investigational Site | Slough | Berkshire |
| United Kingdom | Pfizer Investigational Site | Southall | Middlesex |
| United Kingdom | Pfizer Investigational Site | Southampton | Hampshire |
| United Kingdom | Pfizer Investigational Site | Southampton | |
| United Kingdom | Pfizer Investigational Site | Southend on Sea | Essex |
| United Kingdom | Pfizer Investigational Site | St. Austell | Cornwall |
| United Kingdom | Pfizer Investigational Site | Stirling | Stirlingshire |
| United Kingdom | Pfizer Investigational Site | Sutton-in-Ashfield | Nottinghamshire |
| United Kingdom | Pfizer Investigational Site | Swansea | |
| United Kingdom | Pfizer Investigational Site | Swansea | |
| United Kingdom | Pfizer Investigational Site | Titchfield | Hampshire |
| United Kingdom | Pfizer Investigational Site | Trowbridge | Wiltshire |
| United Kingdom | Pfizer Investigational Site | Trowbridge | Wiltshire |
| United Kingdom | Pfizer Investigational Site | Truro | Cornwall |
| United Kingdom | Pfizer Investigational Site | Tunbridge Wells | Kent |
| United Kingdom | Pfizer Investigational Site | Wakefield | |
| United Kingdom | Pfizer Investigational Site | Warminster | Wiltshire |
| United Kingdom | Pfizer Investigational Site | Waterloo | Liverpool |
| United Kingdom | Pfizer Investigational Site | Watford | Hertfordshire |
| United Kingdom | Pfizer Investigational Site | Westbury | Wiltshire |
| United Kingdom | Pfizer Investigational Site | Weston-Super-Mare | Somerset |
| United Kingdom | Pfizer Investigational Site | Wigan | |
| United Kingdom | Pfizer Investigational Site | Wiltshire | |
| United Kingdom | Pfizer Investigational Site | Wiltshire | |
| United Kingdom | Pfizer Investigational Site | Wiltshire | |
| United Kingdom | Pfizer Investigational Site | Wishaw | |
| United Kingdom | Pfizer Investigational Site | Wolverhampton | West Midlands |
| United Kingdom | Pfizer Investigational Site | Worksop | Nottinghamshire |
| United Kingdom | Pfizer Investigational Site | Wrexham | Clwydd |
| United Kingdom | Pfizer Investigational Site | York | Yorkshire |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer | Department of Health, United Kingdom, Diabetes UK |
United Kingdom,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time from randomization to the occurrence of a primary clinical endpoint | |||
| Primary | i.e. major coronary event or CABG or other coronary revascularization procedure | |||
| Primary | or unstable angina or resuscitated cardiac arrest or stroke. | |||
| Secondary | The incidence rate of a primary clinical and endpoint; the time from randomization | |||
| Secondary | to the occurrence of and the incidence rate of other parameters e.g. total | |||
| Secondary | mortality, any cardiovascular event, new PVD etc. and the percent change from | |||
| Secondary | baseline in various lipid and lipoprotein parameters. |
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