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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00327691
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : May 3, 2007
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cardiovascular Disease Cerebrovascular Accident Coronary Heart Disease Drug: Atorvastatin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 8600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 1998
Study Completion Date : August 2004

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome is the time to occurrence of a major
  2. cardiovascular event, defined as the composite outcome of the
  3. following clinical endpoints
  4. CHD death
  5. Non-fatal/Non-procedure related MI
  6. Resuscitated cardiac arrest or fatal/non-fatal stroke

Secondary Outcome Measures :
  1. The occurrence of the following clinical events
  2. Major coronary event (CHD death, non fatal myocardial infarction or resuscitated cardiac arrest)
  3. any coronary event (major coronary event or CABG
  4. PTCA, other revascularization procedure, procedure-related myocardial infarction, or documented angina)
  5. cerebrovascular event (fatal or non fatal stroke, TIA)
  6. peripheral vascular disease; hospitalization with primary diagnosis' of CHF
  7. any cardiovascular event (any of the above); and all-cause mortality.

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327691


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Publications of Results:

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

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ClinicalTrials.gov Identifier: NCT00327691    
Other Study ID Numbers: 0981-117
A2581136
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: May 3, 2007
Last Verified: May 2007
Keywords provided by Pfizer:
Major cardiovascular event
Major Coronary event
Revascularization
Additional relevant MeSH terms:
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Stroke
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors