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

Phase 4

Completed

• Conditions: Major Coronary Event; Cerebrovascular Accident; Coronary Artery Bypass Graft; Angina, Unstable; Revascularization

• Registration Number: NCT00327418
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-01
• Study Completion: 2004-02
• Study First Submitted: 2006-05-16
• Study First Submitted QC: 2006-05-16
• Study First Posted: 2006-05-18
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-08
• Last Update Posted: 2007-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Wishaw, United Kingdom