A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00327691

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

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

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

Show 330 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

Publications:

Waters DD, LaRosa JC, Barter P, Fruchart JC, Gotto AM Jr, Carter R, Breazna A, Kastelein JJ, Grundy SM. Effects of high-dose atorvastatin on cerebrovascular events in patients with stable coronary disease in the TNT (Treating to New Targets) study. J Am Coll Cardiol. 2006 Nov 7;48(9):1793-9. Epub 2006 Oct 17.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Waters DD. Clinical insights from the treating to new targets trial. Prog Cardiovasc Dis. 2009 May-Jun;51(6):487-502.

Shepherd J, Kastelein JJ, Bittner V, Deedwania P, Breazna A, Dobson S, Wilson DJ, Zuckerman A, Wenger NK; TNT (Treating to New Targets) Investigators. Intensive lipid lowering with atorvastatin in patients with coronary heart disease and chronic kidney disease: the TNT (Treating to New Targets) study. J Am Coll Cardiol. 2008 Apr 15;51(15):1448-54.

Barter P, Gotto AM, LaRosa JC, Maroni J, Szarek M, Grundy SM, Kastelein JJ, Bittner V, Fruchart JC; Treating to New Targets Investigators. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med. 2007 Sep 27;357(13):1301-10.

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

Keywords provided by Pfizer:

Major cardiovascular event
Major Coronary event
Revascularization

Study placed in the following topic categories:

Antimetabolites
Arterial Occlusive Diseases
Heart Diseases
Cerebral Infarction
Antilipemic Agents
Myocardial Ischemia
Stroke
Vascular Diseases
Central Nervous System Diseases
Anticholesteremic Agents
Ischemia

Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Brain Diseases
Cerebrovascular Disorders
Recurrence
Coronary Disease
Brain Ischemia
Brain Infarction
Infarction
Atorvastatin
Coronary Artery Disease

Additional relevant MeSH terms:

Antimetabolites
Cerebral Infarction
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Arterial Occlusive Diseases
Heart Diseases
Antilipemic Agents

Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Coronary Disease
Brain Infarction
Coronary Artery Disease
Atorvastatin

ClinicalTrials.gov processed this record on September 01, 2009