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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00327691
First received: May 16, 2006
Last updated: May 1, 2007
Last verified: May 2007

May 16, 2006
May 1, 2007
April 1998
Not Provided
  • 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
  • The primary outcome is the time to occurrence of a major cardiovascular event, defined as the composite outcome of the following clinical endpoints:
  • Resuscitated cardiac arrest or,
  • CHD death,
  • Non-fatal/non-procedure related MI,
  • Fatal/non-fatal stroke
Complete list of historical versions of study NCT00327691 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
Not Provided
Not Provided
 
A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels
The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Cardiovascular Disease
  • Cerebrovascular Accident
  • Coronary Heart Disease
Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8600
August 2004
Not Provided

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

Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Ireland,   Italy,   Netherlands,   South Africa,   Spain,   Switzerland,   United Kingdom
 
NCT00327691
0981-117, A2581136
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP