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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)

This study has been completed.
Diabetes UK
Department of Health, United Kingdom
Information provided by:
Pfizer Identifier:
First received: May 16, 2006
Last updated: May 8, 2007
Last verified: May 2007
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 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

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

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00327418

  Show 135 Study Locations
Sponsors and Collaborators
Diabetes UK
Department of Health, United Kingdom
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00327418     History of Changes
Other Study ID Numbers: 0981-430-102
Study First Received: May 16, 2006
Last Updated: May 8, 2007

Additional relevant MeSH terms:
Angina, Unstable
Diabetes Mellitus, Type 2
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Myocardial Ischemia
Heart Diseases
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on August 23, 2017