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CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events (CARDS)

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ClinicalTrials.gov Identifier: NCT00327418
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : May 10, 2007
Diabetes UK
Department of Health, United Kingdom
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Major Coronary Event Cerebrovascular Accident Coronary Artery Bypass Graft Angina, Unstable Revascularization Drug: Atorvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 2800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : January 1997
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327418

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Sponsors and Collaborators
Diabetes UK
Department of Health, United Kingdom
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Study Director: Pfizer CT.gov Call Center Pfizer
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00327418    
Other Study ID Numbers: 0981-430-102
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: May 10, 2007
Last Verified: May 2007
Additional relevant MeSH terms:
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Angina, Unstable
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Chest Pain
Neurologic Manifestations
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors