A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels
Phase 4
Completed
- Conditions
- Cardiovascular DiseaseCerebrovascular AccidentCoronary Heart Disease
- Registration Number
- NCT00327691
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8600
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The occurrence of the following clinical events 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 any cardiovascular event (any of the above); and all-cause mortality.
Trial Locations
- Locations (1)
Pfizer Investigational Site