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

Completed

Phase 4 Results

Trial Description

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.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients randomized to either atorvastatin 10 or 80 mg. Low-density lipoprotein cholesterol levels followed for approximately 5 years.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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,cognitive functioning on neuropsychological assessment measures.
Secondary 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.
Primary The primary outcome is the time to occurrence of a major
Primary cardiovascular event, defined as the composite outcome of the
Primary following clinical endpoints
Primary CHD death
Primary Non-fatal/Non-procedure related MI
Primary Resuscitated cardiac arrest or fatal/non-fatal stroke
Secondary The occurrence of the following clinical events
Secondary Major coronary event (CHD death, non fatal myocardial infarction or resuscitated cardiac arrest)
Secondary any coronary event (major coronary event or CABG
Secondary PTCA, other revascularization procedure, procedure-related myocardial infarction, or documented angina)
Secondary cerebrovascular event (fatal or non fatal stroke, TIA)
Secondary peripheral vascular disease; hospitalization with primary diagnosis' of CHF
Secondary any cardiovascular event (any of the above); and all-cause mortality.

Sponsors