Angina, Unstable, Cerebrovascular Accident, Coronary Artery Bypass Graft, Major Coronary Event, Revascularization
Conditions
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.
Interventions
DRUGAtorvastatin
Sponsors
Diabetes UK
Department of Health, United Kingdom
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The incidence rate of a primary clinical and endpoint; the time from randomization | — |
| baseline in various lipid and lipoprotein parameters. | — |
| 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 | — |
Countries
United Kingdom
Outcome results
None listed