Cardiovascular Disease, Cerebrovascular Accident, Coronary Heart Disease
Conditions
Keywords
Major cardiovascular event, Major Coronary event, Revascularization
Brief summary
The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.
Interventions
DRUGAtorvastatin
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Men and women age 35-75 who have evident CHD
Exclusion criteria
Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary hyperlipidemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the time to occurrence of a major | — |
| cardiovascular event, defined as the composite outcome of the | — |
| following clinical endpoints | — |
| CHD death | — |
| Non-fatal/Non-procedure related MI | — |
| Resuscitated cardiac arrest or fatal/non-fatal stroke | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence of the following clinical events | — |
| any cardiovascular event (any of the above); and all-cause mortality. | — |
| Major coronary event (CHD death, non fatal myocardial infarction or resuscitated cardiac arrest) | — |
| any coronary event (major coronary event or CABG | — |
| PTCA, other revascularization procedure, procedure-related myocardial infarction, or documented angina) | — |
| cerebrovascular event (fatal or non fatal stroke, TIA) | — |
| peripheral vascular disease; hospitalization with primary diagnosis' of CHF | — |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, South Africa, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed