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

Completed

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Time from randomization to the occurrence of a primary clinical endpoint
Primary i.e. major coronary event or CABG or other coronary revascularization procedure
Primary or unstable angina or resuscitated cardiac arrest or stroke.
Secondary The incidence rate of a primary clinical and endpoint; the time from randomization
Secondary to the occurrence of and the incidence rate of other parameters e.g. total
Secondary mortality, any cardiovascular event, new PVD etc. and the percent change from
Secondary baseline in various lipid and lipoprotein parameters.

Sponsors