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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
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Cerebrovascular Accident
Coronary Heart Disease
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 8600
Study Start Date: April 1998
Estimated Study Completion Date: August 2004
  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327691

  Show 314 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00327691     History of Changes
Other Study ID Numbers: 0981-117, A2581136
Study First Received: May 16, 2006
Last Updated: May 1, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Major cardiovascular event
Major Coronary event
Revascularization

Additional relevant MeSH terms:
Cardiovascular Diseases
Cerebral Infarction
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Stroke
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Brain Infarction
Brain Ischemia
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014