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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Cerebrovascular Accident; Coronary Heart Disease; Cardiovascular Disease

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00327691

0981-117

A2581136

Details and patient eligibility

About

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.

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind