Back to resultsCARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events (CARDS)
Primary Purpose
Major Coronary Event, Cerebrovascular Accident, Coronary Artery Bypass Graft
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
About this trial
This is an interventional prevention trial for Major Coronary Event
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
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
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.
Full Information
NCT ID
NCT00327418
First Posted
May 16, 2006
Last Updated
May 8, 2007
Sponsor
Pfizer
Collaborators
Diabetes UK, Department of Health, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT00327418
Brief Title
CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events
Acronym
CARDS
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
Collaborators
Diabetes UK, Department of Health, United Kingdom
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Coronary Event, Cerebrovascular Accident, Coronary Artery Bypass Graft, Angina, Unstable, Revascularization
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2800 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
Time from randomization to the occurrence of a primary clinical endpoint
Title
i.e. major coronary event or CABG or other coronary revascularization procedure
Title
or unstable angina or resuscitated cardiac arrest or stroke.
Secondary Outcome Measure Information:
Title
The incidence rate of a primary clinical and endpoint; the time from randomization
Title
to the occurrence of and the incidence rate of other parameters e.g. total
Title
mortality, any cardiovascular event, new PVD etc. and the percent change from
Title
baseline in various lipid and lipoprotein parameters.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Fosterhill
State/Province
Aberdeen
ZIP/Postal Code
AB25 2XG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Irvine
State/Province
Ayrshire
ZIP/Postal Code
KA12 0AY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Midsomer Norton
State/Province
Bath
ZIP/Postal Code
BA3 2UH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG2 7AG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Slough
State/Province
Berkshire
ZIP/Postal Code
SL1 2AD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Maidenhead
State/Province
Berskhire
ZIP/Postal Code
SL6 6EL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Edgbaston
State/Province
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Frenchay
State/Province
Bristol
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Llanishen
State/Province
Cardiff
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wrexham
State/Province
Clwydd
ZIP/Postal Code
LL13 7TD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bocastle
State/Province
Cornwall
ZIP/Postal Code
PL35 0BG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Falmouth
State/Province
Cornwall
ZIP/Postal Code
TR11 2LH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Fowey
State/Province
Cornwall
ZIP/Postal Code
PL23 1DT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Penzance
State/Province
Cornwall
ZIP/Postal Code
TR18 4JH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Penzance
State/Province
Cornwall
ZIP/Postal Code
TR19 7HX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Redruth
State/Province
Cornwall
ZIP/Postal Code
TR15 2LL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Saltash
State/Province
Cornwall
ZIP/Postal Code
PL12 6DL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
St. Austell
State/Province
Cornwall
ZIP/Postal Code
PL26 7RL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chesterfield
State/Province
Derbyshire
ZIP/Postal Code
S40 4TF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Crownhill, Plymouth
State/Province
Devon
ZIP/Postal Code
PL5 3JB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 7TH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Plympton
State/Province
Devon
ZIP/Postal Code
PL7 1AD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH8 9EW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Epping
State/Province
Essex
ZIP/Postal Code
CM16 6TN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Southend on Sea
State/Province
Essex
ZIP/Postal Code
SS1 2AB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Langside
State/Province
Glasgow
ZIP/Postal Code
G42 9TY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO31 7DQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Titchfield
State/Province
Hampshire
ZIP/Postal Code
PO14 4EH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Hemel Hempstead
State/Province
Hertfordshire
ZIP/Postal Code
HP2 4AD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Watford
State/Province
Hertfordshire
ZIP/Postal Code
WD18 0HB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ryde
State/Province
Isle of Wight
ZIP/Postal Code
PO33 2EH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Gillingham
State/Province
Kent
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Hildenborough
State/Province
Kent
ZIP/Postal Code
TN11 9HL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Tunbridge Wells
State/Province
Kent
ZIP/Postal Code
TN1 2DX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bolton
State/Province
Lancashire
ZIP/Postal Code
BL4 0JR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ormskirk
State/Province
Lancashire
ZIP/Postal Code
L39 2AZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Waterloo
State/Province
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
State/Province
M15 6sx
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ashford
State/Province
Middlesex
ZIP/Postal Code
TW15 2TU
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Southall
State/Province
Middlesex
ZIP/Postal Code
UB1 3HW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Scunthorpe
State/Province
North Lincolnshire
ZIP/Postal Code
DN15 7BH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Harrogate
State/Province
North Yorkshire
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Northallerton
State/Province
North Yorkshire
ZIP/Postal Code
DL6 1JG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sutton-in-Ashfield
State/Province
Nottinghamshire
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Worksop
State/Province
Nottinghamshire
ZIP/Postal Code
S80 1HP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Huthwaite
State/Province
Nottingham
ZIP/Postal Code
NG17 2LR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Haverfordwest
State/Province
Pembrokeshire
ZIP/Postal Code
SA61 1QX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Haverfordwest
State/Province
Pembrokeshire
ZIP/Postal Code
SA61 2PZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Shrewsbury
State/Province
Shropshire
ZIP/Postal Code
SY3 8XG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Frome
State/Province
Somerset
ZIP/Postal Code
BA11 1EZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Weston-Super-Mare
State/Province
Somerset
ZIP/Postal Code
BS23 4TQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S5 7HD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S5 7QB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S7 2DW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Stirling
State/Province
Stirlingshire
ZIP/Postal Code
FK8 2AU
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Carshalton
State/Province
Surrey
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Epsom
State/Province
Surrey
ZIP/Postal Code
KT18 7EG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Pontarddulais
State/Province
Swansea
ZIP/Postal Code
SA4 1TL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
State/Province
Tayside
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
State/Province
Tayside
ZIP/Postal Code
DD2 5NH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Hetton le Hole
State/Province
Tyne & Wear
ZIP/Postal Code
DH5 9EZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Gateshead
State/Province
Tyne and Wear
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Nuneaton
State/Province
Warwickshire
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Rugby
State/Province
Warwickshire
ZIP/Postal Code
CV22 5PX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Lyndon
State/Province
West Bromwich, West Midlands
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Livingston
State/Province
West Lothian
ZIP/Postal Code
EH54 6PP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Crawley
State/Province
West Sussex
ZIP/Postal Code
RH10 1LL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Crawley
State/Province
West Sussex
ZIP/Postal Code
RH10 7DX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Haywards Heath
State/Province
West Sussex
ZIP/Postal Code
RH16 4EX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Corsham
State/Province
Wiltshire
ZIP/Postal Code
SN13 9DL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Trowbridge
State/Province
Wiltshire
ZIP/Postal Code
BA14 7EG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Trowbridge
State/Province
Wiltshire
ZIP/Postal Code
BA14 9AR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Warminster
State/Province
Wiltshire
ZIP/Postal Code
BA14 9AA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Westbury
State/Province
Wiltshire
ZIP/Postal Code
BA13 3JD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
York
State/Province
Yorkshire
ZIP/Postal Code
YO31 8HE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ayr
ZIP/Postal Code
KA6 6DX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ayr
ZIP/Postal Code
KA7 2AA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
ZIP/Postal Code
BA1 2SR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
ZIP/Postal Code
BA2 1NH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
ZIP/Postal Code
BA2 3HT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
ZIP/Postal Code
BA2 4BY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Belfast
ZIP/Postal Code
BT14 6AB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Birmingham
ZIP/Postal Code
B37 7TR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chippenham, Wiltshire
ZIP/Postal Code
SN15 2SB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Co. Dublin
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Coventry
ZIP/Postal Code
CV1 4FH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Derby
ZIP/Postal Code
DE22 3DT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dewsbury
ZIP/Postal Code
WF13 4HS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dublin 8
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dumfries
ZIP/Postal Code
DG1 4AP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
East Kilbride
ZIP/Postal Code
G75 8RG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Hartlepool
ZIP/Postal Code
TS24 9AH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Hertfordshire
ZIP/Postal Code
AL7 4HQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Hertfordshire
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Inverness
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Llantrisant
ZIP/Postal Code
CF72 8XR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M41 5SL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Oldham
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Paisley
ZIP/Postal Code
PA2 9PN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Pontefract
ZIP/Postal Code
WF8 1PL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Southampton
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Swansea
ZIP/Postal Code
SA1 1HW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Swansea
ZIP/Postal Code
SA1 4DF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wigan
ZIP/Postal Code
WN1 1XX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wiltshire
ZIP/Postal Code
BA15 1DQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wiltshire
ZIP/Postal Code
SN12 7EA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wiltshire
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wishaw
ZIP/Postal Code
ML2 0DP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
17065671
Citation
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.
Results Reference
result
PubMed Identifier
31020900
Citation
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.
Results Reference
derived
PubMed Identifier
30571333
Citation
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.
Results Reference
derived
PubMed Identifier
28573499
Citation
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.
Results Reference
derived
PubMed Identifier
27513651
Citation
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.
Results Reference
derived
PubMed Identifier
27174798
Citation
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.
Results Reference
derived
PubMed Identifier
25899452
Citation
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.
Results Reference
derived
PubMed Identifier
22368281
Citation
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.
Results Reference
derived
PubMed Identifier
19540640
Citation
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.
Results Reference
derived
PubMed Identifier
18972097
Citation
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.
Results Reference
derived
PubMed Identifier
18777490
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0981-430-102&StudyName=CARDS+is+designed+to+show+if+lowering+cholesterol+with+atorvastatin+in+Type+2+diabetics+without+CV+disease+reduces+
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events
We'll reach out to this number within 24 hrs