CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events - Full Text View

Sponsor:	Pfizer
Collaborators:	Diabetes UK Department of Health, United Kingdom
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00327418

Purpose

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.

Condition	Intervention	Phase
Major Coronary Event Cerebrovascular Accident Coronary Artery Bypass Graft Angina, Unstable Revascularization	Drug: Atorvastatin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
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)

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Angina Coronary Artery Bypass Surgery Diabetes Diabetes Type 2 High Blood Pressure

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Pfizer:

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.

Estimated Enrollment:	2800
Study Start Date:	January 1997
Estimated Study Completion Date:	February 2004

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327418

Show 135 Study Locations

Sponsors and Collaborators

Pfizer

Diabetes UK

Department of Health, United Kingdom

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. 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. Epub 2008 Oct 30.

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.

ClinicalTrials.gov Identifier:	NCT00327418 History of Changes
Other Study ID Numbers:	0981-430-102, A2581143
Study First Received:	May 16, 2006
Last Updated:	May 8, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Angina, Unstable
Diabetes Mellitus, Type 2
Cerebral Infarction
Stroke
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012