A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels

Pfizer8,600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

8,600

Conditions

Cardiovascular Disease Cerebrovascular Accident Coronary Heart Disease

Interventions

AtorvastatinDRUG

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (314)

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Alabaster, Alabama, United States

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Hoover, Alabama, United States

Pfizer Investigational Site

Montgomery, Alabama, United States

Pfizer Investigational Site

Mesa, Arizona, United States

Pfizer Investigational Site

Mesa, Arizona, United States

Pfizer Investigational Site

Burbank, California, United States

Pfizer Investigational Site

Camp Pendleton, California, United States

...and 304 more locations