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OpenTrials
Completed

NCT Number: NCT00327418

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

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.

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Key information

Conditions

Major Coronary Event Angina Pectoris Angina, Unstable Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Chest Pain Coronary Artery Bypass Graft Heart Diseases Myocardial Ischemia Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Revascularization Signs and Symptoms Stroke Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Fosterhill, Aberdeen, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Department of Health, United Kingdom
  • Diabetes UK

Registry information

Official study 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)

Acronym: CARDS

Important dates

Study start
1997
Study completion
2004
First posted
May 18, 2006
Registry last updated
May 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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