Clinical trial NCT00327691: A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
Cerebrovascular Accident
Coronary Heart Disease
Keywords: Major cardiovascular event
Major Coronary event
Revascularization
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 8600
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: The primary outcome is the time to occurrence of a major
measure: cardiovascular event, defined as the composite outcome of the
measure: following clinical endpoints
measure: CHD death
measure: Non-fatal/Non-procedure related MI
measure: Resuscitated cardiac arrest or fatal/non-fatal stroke
Secondary outcomes:
measure: The occurrence of the following clinical events
measure: Major coronary event (CHD death, non fatal myocardial infarction or resuscitated cardiac arrest)
measure: any coronary event (major coronary event or CABG
measure: PTCA, other revascularization procedure, procedure-related myocardial infarction, or documented angina)
measure: cerebrovascular event (fatal or non fatal stroke, TIA)
measure: peripheral vascular disease; hospitalization with primary diagnosis' of CHF
measure: any cardiovascular event (any of the above); and all-cause mortality.
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Hoover
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Burbank
country: United States
facility: Pfizer Investigational Site
state: California
city: Camp Pendleton
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Loma Linda
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Modesto
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Rosa
country: United States
facility: Pfizer Investigational Site
state: California
city: Stanford
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Bridgeport
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainsville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainsville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Inverness
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lakeland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port Charlotte
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Stuart
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tamarac
country: United States
facility: Pfizer Investigational Site
state: Florida
city: The Villages
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Canton
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Berwyn
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Blue Island
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: DuQuoin
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Evanston
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Lake Forest
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Marion
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Pekin
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Beech Grove
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fort Wayne
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fort Wayne
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Scottsburg
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lathe
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Edgewood
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Erlanger
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Marrero
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Bel Air
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Westminster
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Dearborn
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Farmington Hill
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Sterling Heights
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: West Bloomfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Duluth
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Maplewood
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St. Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Papillion
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Manchester
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Hawthorne
country: United States
facility: Pfizer Investigational Site
state: New York
city: Manlius
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Valhalla
country: United States
facility: Pfizer Investigational Site
state: New York
city: Asheville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Eden
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Kettering
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lorain
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Sandusky
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lansdale
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lehighton
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pawtucket
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Sioux Falls
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Denton
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lackland AFB
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: St. Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Auchenflower
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Brisbane
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Chermside
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Greenslopes
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Herston
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Milton
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Bedford Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Hobart
country: Australia
facility: Pfizer Investigational Site
state: Tasmania
city: Clayton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Prahran
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Feldkirch
country: Austria
facility: Pfizer Investigational Site
city: Oberpullendorf
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Aalst
country: Belgium
facility: Pfizer Investigational Site
city: Antwerpen
country: Belgium
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Godinne
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Lommel
country: Belgium
facility: Pfizer Investigational Site
city: Neerpelt
country: Belgium
facility: Pfizer Investigational Site
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Nanaimo
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St-foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Pessac
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Agen
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Brest
country: France
facility: Pfizer Investigational Site
city: Clermont-ferrand
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Paris CEDEX 05
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: Roubaix Cdx
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Schwerte
country: Germany
facility: Pfizer Investigational Site
city: Tostedt
country: Germany
facility: Pfizer Investigational Site
city: Wurzburg
country: Germany
facility: Pfizer Investigational Site
city: Cork
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Cuneo
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Rome
country: Italy
facility: Pfizer Investigational Site
city: Udine
country: Italy
facility: Pfizer Investigational Site
city: 's-Hertogenbosch
country: Netherlands
facility: Pfizer Investigational Site
city: Alkmaar
country: Netherlands
facility: Pfizer Investigational Site
city: Amersfoort
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Enschede
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Leiden
country: Netherlands
facility: Pfizer Investigational Site
city: Nieuwegein
country: Netherlands
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Zwolle
country: Netherlands
facility: Pfizer Investigational Site
city: Zwolle
country: Netherlands
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Sunninghill
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Parow
country: South Africa
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Cordoba
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: San Sebastian
country: Spain
facility: Pfizer Investigational Site
city: Santiago de Compostela
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valladolid
country: Spain
facility: Pfizer Investigational Site
city: Zaragoza
country: Spain
facility: Pfizer Investigational Site
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
city: Geneve 14
country: Switzerland
facility: Pfizer Investigational Site
city: Lausanne
country: Switzerland
facility: Pfizer Investigational Site
city: Lugano
country: Switzerland
facility: Pfizer Investigational Site
city: St Gallen
country: Switzerland
facility: Pfizer Investigational Site
city: Romford
country: United Kingdom
facility: Pfizer Investigational Site
state: Essex
city: London
country: United Kingdom
facility: Pfizer Investigational Site
state: Greater London
city: London
country: United Kingdom
facility: Pfizer Investigational Site
state: Greater London
city: London
country: United Kingdom
facility: Pfizer Investigational Site
state: Greater London
city: Aldershot
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: Farnborough
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Blackpool
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancashire
city: Leicester
country: United Kingdom
facility: Pfizer Investigational Site
state: Leicestershire
city: London
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
state: West Midlands
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
state: West Midlands
city: Swindon
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Barnet
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Paisley
country: United Kingdom
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/j.jacc.2006.07.041. Epub 2006 Oct 17.
citation: Vogt L, Bangalore S, Fayyad R, Melamed S, Hovingh GK, DeMicco DA, Waters DD. Atorvastatin Has a Dose-Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double-Blind Randomized Controlled Trials. J Am Heart Assoc. 2019 May 7;8(9):e010827. doi: 10.1161/JAHA.118.010827.
citation: Bangalore S, Fayyad R, DeMicco DA, Colhoun HM, Waters DD. Body Weight Variability and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004724. doi: 10.1161/CIRCOUTCOMES.118.004724.
citation: Kaasenbrood L, Ray KK, Boekholdt SM, Smulders YM, LaRosa JC, Kastelein JJP, van der Graaf Y, Dorresteijn JAN, Visseren FLJ. Estimated individual lifetime benefit from PCSK9 inhibition in statin-treated patients with coronary artery disease. Heart. 2018 Oct;104(20):1699-1705. doi: 10.1136/heartjnl-2017-312510. Epub 2018 Apr 5.
citation: Vallejo-Vaz AJ, Fayyad R, Boekholdt SM, Hovingh GK, Kastelein JJ, Melamed S, Barter P, Waters DD, Ray KK. Triglyceride-Rich Lipoprotein Cholesterol and Risk of Cardiovascular Events Among Patients Receiving Statin Therapy in the TNT Trial. Circulation. 2018 Aug 21;138(8):770-781. doi: 10.1161/CIRCULATIONAHA.117.032318.
citation: Ong KL, Waters DD, Fayyad R, Vogt L, Melamed S, DeMicco DA, Rye KA, Barter PJ. Relationship of High-Density Lipoprotein Cholesterol With Renal Function in Patients Treated With Atorvastatin. J Am Heart Assoc. 2018 Jan 22;7(2):e007387. doi: 10.1161/JAHA.117.007387.
citation: Ports WC, Fayyad R, DeMicco DA, Laskey R, Wolk R. Effectiveness of Lipid-Lowering Statin Therapy in Patients With and Without Psoriasis. Clin Drug Investig. 2017 Aug;37(8):775-785. doi: 10.1007/s40261-017-0533-0.
citation: Bangalore S, Fayyad R, Laskey R, DeMicco DA, Messerli FH, Waters DD. Body-Weight Fluctuations and Outcomes in Coronary Disease. N Engl J Med. 2017 Apr 6;376(14):1332-1340. doi: 10.1056/NEJMoa1606148.
citation: Stam-Slob MC, van der Graaf Y, Greving JP, Dorresteijn JA, Visseren FL. Cost-Effectiveness of Intensifying Lipid-Lowering Therapy With Statins Based on Individual Absolute Benefit in Coronary Artery Disease Patients. J Am Heart Assoc. 2017 Feb 18;6(2):e004648. doi: 10.1161/JAHA.116.004648.
citation: Deedwania PC, Pedersen TR, DeMicco DA, Breazna A, Betteridge DJ, Hitman GA, Durrington P, Neil A; TNT, CARDS and IDEAL Steering Committees and Investigators. Differing predictive relationships between baseline LDL-C, systolic blood pressure, and cardiovascular outcomes. Int J Cardiol. 2016 Nov 1;222:548-556. doi: 10.1016/j.ijcard.2016.07.201. Epub 2016 Jul 30.
citation: Byun YS, Lee JH, Arsenault BJ, Yang X, Bao W, DeMicco D, Laskey R, Witztum JL, Tsimikas S; TNT Trial Investigators. Relationship of oxidized phospholipids on apolipoprotein B-100 to cardiovascular outcomes in patients treated with intensive versus moderate atorvastatin therapy: the TNT trial. J Am Coll Cardiol. 2015 Apr 7;65(13):1286-1295. doi: 10.1016/j.jacc.2015.01.050.
citation: Arsenault BJ, Barter P, DeMicco DA, Bao W, Preston GM, LaRosa JC, Grundy SM, Deedwania P, Greten H, Wenger NK, Shepherd J, Waters DD, Kastelein JJ; Treating to New Targets (TNT) Investigators. Prediction of cardiovascular events in statin-treated stable coronary patients of the treating to new targets randomized controlled trial by lipid and non-lipid biomarkers. PLoS One. 2014 Dec 22;9(12):e114519. doi: 10.1371/journal.pone.0114519. eCollection 2014.
citation: Dorresteijn JA, Boekholdt SM, van der Graaf Y, Kastelein JJ, LaRosa JC, Pedersen TR, DeMicco DA, Ridker PM, Cook NR, Visseren FL. High-dose statin therapy in patients with stable coronary artery disease: treating the right patients based on individualized prediction of treatment effect. Circulation. 2013 Jun 25;127(25):2485-93. doi: 10.1161/CIRCULATIONAHA.112.000712. Epub 2013 May 14.
citation: Semb AG, Kvien TK, DeMicco DA, Fayyad R, Wun CC, LaRosa JC, Betteridge J, Pedersen TR, Holme I. Effect of intensive lipid-lowering therapy on cardiovascular outcome in patients with and those without inflammatory joint disease. Arthritis Rheum. 2012 Sep;64(9):2836-46. doi: 10.1002/art.34524.
citation: Huijgen R, Boekholdt SM, Arsenault BJ, Bao W, Davaine JM, Tabet F, Petrides F, Rye KA, DeMicco DA, Barter PJ, Kastelein JJ, Lambert G. Plasma PCSK9 levels and clinical outcomes in the TNT (Treating to New Targets) trial: a nested case-control study. J Am Coll Cardiol. 2012 May 15;59(20):1778-84. doi: 10.1016/j.jacc.2011.12.043.
citation: Mora S, Wenger NK, Demicco DA, Breazna A, Boekholdt SM, Arsenault BJ, Deedwania P, Kastelein JJ, Waters DD. Determinants of residual risk in secondary prevention patients treated with high- versus low-dose statin therapy: the Treating to New Targets (TNT) study. Circulation. 2012 Apr 24;125(16):1979-87. doi: 10.1161/CIRCULATIONAHA.111.088591. Epub 2012 Mar 29.
citation: Arsenault BJ, Boekholdt SM, Hovingh GK, Hyde CL, DeMicco DA, Chatterjee A, Barter P, Deedwania P, Waters DD, LaRosa JC, Pedersen TR, Kastelein JJ; TNT and IDEAL Investigators. The 719Arg variant of KIF6 and cardiovascular outcomes in statin-treated, stable coronary patients of the treating to new targets and incremental decrease in end points through aggressive lipid-lowering prospective studies. Circ Cardiovasc Genet. 2012 Feb 1;5(1):51-7. doi: 10.1161/CIRCGENETICS.111.960252. Epub 2011 Dec 1.
citation: Arsenault BJ, Barter P, DeMicco DA, Bao W, Preston GM, LaRosa JC, Grundy SM, Deedwania P, Greten H, Wenger NK, Shepherd J, Waters DD, Kastelein JJ; TNT Study Investigators. Prediction of cardiovascular events in statin-treated stable coronary patients by lipid and nonlipid biomarkers. J Am Coll Cardiol. 2011 Jan 4;57(1):63-9. doi: 10.1016/j.jacc.2010.06.052.
citation: Hyde CL, Macinnes A, Sanders FA, Thompson JF, Mazzarella RA, Faergeman O, van Wijk DF, Wood L, Lira M, Paciga SA. Genetic association of the CCR5 region with lipid levels in at-risk cardiovascular patients. Circ Cardiovasc Genet. 2010 Apr;3(2):162-8. doi: 10.1161/CIRCGENETICS.109.897793. Epub 2010 Feb 3.
citation: Waters DD. Clinical insights from the Treating to New Targets trial. Prog Cardiovasc Dis. 2009 May-Jun;51(6):487-502. doi: 10.1016/j.pcad.2009.01.001.
citation: Shepherd J, Kastelein JP, Bittner VA, Carmena R, Deedwania PC, Breazna A, Dobson S, Wilson DJ, Zuckerman AL, Wenger NK; Treating to New Targets Steering Committee and Investigators. Intensive lipid lowering with atorvastatin in patients with coronary artery disease, diabetes, and chronic kidney disease. Mayo Clin Proc. 2008 Aug;83(8):870-9.
citation: Shah SJ, Waters DD, Barter P, Kastelein JJ, Shepherd J, Wenger NK, DeMicco DA, Breazna A, LaRosa JC. Intensive lipid-lowering with atorvastatin for secondary prevention in patients after coronary artery bypass surgery. J Am Coll Cardiol. 2008 May 20;51(20):1938-43. doi: 10.1016/j.jacc.2007.12.054.
citation: 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. doi: 10.1016/j.jacc.2007.11.072.
citation: 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. doi: 10.1056/NEJMoa064278.