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

This study has been completed.
Sponsor:
Collaborators:
Diabetes UK
Department of Health, United Kingdom
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00327418
First received: May 16, 2006
Last updated: May 8, 2007
Last verified: May 2007
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 29, 2014