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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Coronary Heart Disease; Cerebrovascular Accident
• Intervention / Treatment: Drug: Atorvastatin

• Study Type: Interventional
• Enrollment: 8600
• Phase: Phase 4

Contacts and Locations

Study Locations

• • • Pfizer Investigational Site
• Australia
  • New South Wales
    • St. Leonards, New South Wales, Australia, 2065
      • Pfizer Investigational Site
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Pfizer Investigational Site
    • Brisbane, Queensland, Australia, 4029
      • Pfizer Investigational Site
    • Chermside, Queensland, Australia, 4032
      • Pfizer Investigational Site
    • Greenslopes, Queensland, Australia, 4130
      • Pfizer Investigational Site
    • Herston, Queensland, Australia, 4029
      • Pfizer Investigational Site
    • Milton, Queensland, Australia, 4064
      • Pfizer Investigational Site
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Pfizer Investigational Site
    • Bedford Park, South Australia, Australia, 5042
      • Pfizer Investigational Site
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Pfizer Investigational Site
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Pfizer Investigational Site
    • Parkville, Victoria, Australia, 3050
      • Pfizer Investigational Site
    • Prahran, Victoria, Australia, 3181
      • Pfizer Investigational Site
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Pfizer Investigational Site
• Austria
  • Feldkirch, Austria, A-6807
    • Pfizer Investigational Site
  • Oberpullendorf, Austria, A-7350
    • Pfizer Investigational Site
  • Wien, Austria, A-1090
    • Pfizer Investigational Site
  • Wien, Austria, 1100
    • Pfizer Investigational Site
• Belgium
  • Aalst, Belgium, 9300
    • Pfizer Investigational Site
  • Antwerpen, Belgium, B-2020
    • Pfizer Investigational Site
  • Genk, Belgium, 3600
    • Pfizer Investigational Site
  • Genk, Belgium, B-3600
    • Pfizer Investigational Site
  • Godinne, Belgium, 5530
    • Pfizer Investigational Site
  • Leuven, Belgium, 3000
    • Pfizer Investigational Site
  • Lommel, Belgium, 3920
    • Pfizer Investigational Site
  • Neerpelt, Belgium, 3910
    • Pfizer Investigational Site
• Canada
  • Quebec, Canada, G1R 2J6
    • Pfizer Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2E 7C5
      • Pfizer Investigational Site
    • Calgary, Alberta, Canada, T2N 4N1
      • Pfizer Investigational Site
    • Edmonton, Alberta, Canada, T5R 4H5
      • Pfizer Investigational Site
    • Edmonton, Alberta, Canada, T6G 2B7
      • Pfizer Investigational Site
  • British Columbia
    • Nanaimo, British Columbia, Canada, V9S 2B8
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada, V6R 1Y6
      • Pfizer Investigational Site
    • Victoria, British Columbia, Canada, V8T 5G4
      • Pfizer Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Pfizer Investigational Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Pfizer Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Pfizer Investigational Site
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Pfizer Investigational Site
    • London, Ontario, Canada, N6A 4G5
      • Pfizer Investigational Site
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Pfizer Investigational Site
    • Sudbury, Ontario, Canada, P3E 1B8
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5C 2T2
      • Pfizer Investigational Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H3A 1A1
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H1T 1C8
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H2W 1R7
      • Pfizer Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Pfizer Investigational Site
    • St-foy, Quebec, Canada, G1V 4G2
      • Pfizer Investigational Site
• France
  • Agen, France, 47000
    • Pfizer Investigational Site
  • Bordeaux, France, 33000
    • Pfizer Investigational Site
  • Brest, France, 29200
    • Pfizer Investigational Site
  • Clermont-ferrand, France, 63003
    • Pfizer Investigational Site
  • Lyon, France, 69003
    • Pfizer Investigational Site
  • Marseille, France, 13915 Cedex 20
    • Pfizer Investigational Site
  • Paris CEDEX 05, France, 75230
    • Pfizer Investigational Site
  • Rennes, France, 35033
    • Pfizer Investigational Site
  • Roubaix Cdx, France, 59056
    • Pfizer Investigational Site
  • Strasbourg, France, 67091
    • Pfizer Investigational Site
  • Toulouse, France, 31059
    • Pfizer Investigational Site
  • Toulouse, France, 31400
    • Pfizer Investigational Site
  • Cedex
    • Pessac, Cedex, France, 33604
      • Pfizer Investigational Site
• Germany
  • Berlin, Germany, 13353
    • Pfizer Investigational Site
  • Berlin, Germany, 13439
    • Pfizer Investigational Site
  • Essen, Germany, 45329
    • Pfizer Investigational Site
  • Hamburg, Germany, 20246
    • Pfizer Investigational Site
  • Schwerte, Germany, D-58239
    • Pfizer Investigational Site
  • Tostedt, Germany, 21255
    • Pfizer Investigational Site
  • Wurzburg, Germany, 97070
    • Pfizer Investigational Site
• Ireland
  • Cork, Ireland
    • Pfizer Investigational Site
  • Dublin, Ireland, D8
    • Pfizer Investigational Site
• Italy
  • Bologna, Italy, 40138
    • Pfizer Investigational Site
  • Bologna, Italy, 40139
    • Pfizer Investigational Site
  • Cuneo, Italy, 12100
    • Pfizer Investigational Site
  • Firenze, Italy, 50134
    • Pfizer Investigational Site
  • Napoli, Italy, 80131
    • Pfizer Investigational Site
  • Rome, Italy, 00184
    • Pfizer Investigational Site
  • Udine, Italy, 33100
    • Pfizer Investigational Site
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5211 NL
    • Pfizer Investigational Site
  • Alkmaar, Netherlands, 1815 JD
    • Pfizer Investigational Site
  • Amersfoort, Netherlands, 3818 ES
    • Pfizer Investigational Site
  • Amsterdam, Netherlands, 1105 AZ
    • Pfizer Investigational Site
  • Breda, Netherlands, 4818 CK
    • Pfizer Investigational Site
  • Eindhoven, Netherlands, 5623 EJ
    • Pfizer Investigational Site
  • Enschede, Netherlands, 7513 ER
    • Pfizer Investigational Site
  • Groningen, Netherlands, 9713 GZ
    • Pfizer Investigational Site
  • Groningen, Netherlands, 9728 NZ
    • Pfizer Investigational Site
  • Leiden, Netherlands, 2333 ZA
    • Pfizer Investigational Site
  • Nieuwegein, Netherlands, 3435 CM
    • Pfizer Investigational Site
  • Nijmegen, Netherlands, 6532 SZ
    • Pfizer Investigational Site
  • Zwolle, Netherlands, 8011 JW
    • Pfizer Investigational Site
  • Zwolle, Netherlands, 8025 AB
    • Pfizer Investigational Site
• South Africa
  • Bloemfontein, South Africa, 9301
    • Pfizer Investigational Site
  • Cape Town, South Africa, 7500
    • Pfizer Investigational Site
  • Cape Town, South Africa, 7405
    • Pfizer Investigational Site
  • Parow, South Africa, 7505
    • Pfizer Investigational Site
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Pfizer Investigational Site
    • Sunninghill, Gauteng, South Africa, 2157
      • Pfizer Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • Pfizer Investigational Site
  • Barcelona, Spain, 08036
    • Pfizer Investigational Site
  • Cordoba, Spain, 14004
    • Pfizer Investigational Site
  • Madrid, Spain, 28007
    • Pfizer Investigational Site
  • Madrid, Spain, 28041
    • Pfizer Investigational Site
  • Madrid, Spain, 28029
    • Pfizer Investigational Site
  • Madrid, Spain, 28040
    • Pfizer Investigational Site
  • San Sebastian, Spain, 20014
    • Pfizer Investigational Site
  • Santiago de Compostela, Spain, 15706
    • Pfizer Investigational Site
  • Sevilla, Spain, 41013
    • Pfizer Investigational Site
  • Sevilla, Spain, 41009
    • Pfizer Investigational Site
  • Valladolid, Spain, 47011
    • Pfizer Investigational Site
  • Zaragoza, Spain, 50009
    • Pfizer Investigational Site
• Switzerland
  • Bern, Switzerland, 3010
    • Pfizer Investigational Site
  • Geneve 14, Switzerland, CH-1211
    • Pfizer Investigational Site
  • Lausanne, Switzerland, CH-1011
    • Pfizer Investigational Site
  • Lugano, Switzerland, 6900
    • Pfizer Investigational Site
  • St Gallen, Switzerland, CH-9007
    • Pfizer Investigational Site
• United Kingdom
  • Barnet, United Kingdom, EN5 3DJ
    • Pfizer Investigational Site
  • Glasgow, United Kingdom, G11 6NT
    • Pfizer Investigational Site
  • London, United Kingdom, E1 1BB
    • Pfizer Investigational Site
  • London, United Kingdom, NW3 2PF
    • Pfizer Investigational Site
  • Paisley, United Kingdom, P1 1HR
    • Pfizer Investigational Site
  • Essex
    • Romford, Essex, United Kingdom, RM7 OBE
      • Pfizer Investigational Site
  • Greater London
    • London, Greater London, United Kingdom, E2 9JX
      • Pfizer Investigational Site
    • London, Greater London, United Kingdom, NW10 7NS
      • Pfizer Investigational Site
    • London, Greater London, United Kingdom, SW17 0RE
      • Pfizer Investigational Site
  • Hampshire
    • Aldershot, Hampshire, United Kingdom, GU11 3RB
      • Pfizer Investigational Site
  • Kent
    • Farnborough, Kent, United Kingdom, BR6 7AR
      • Pfizer Investigational Site
  • Lancashire
    • Blackpool, Lancashire, United Kingdom, FY3 8NR
      • Pfizer Investigational Site
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE3 9QP
      • Pfizer Investigational Site
  • Middlesex
    • London, Middlesex, United Kingdom, HA8 0AD
      • Pfizer Investigational Site
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV1 4FH
      • Pfizer Investigational Site
    • Coventry, West Midlands, United Kingdom, CV2 2DX
      • Pfizer Investigational Site
  • Wiltshire
    • Swindon, Wiltshire, United Kingdom, SN3 6BB
      • Pfizer Investigational Site
• United States
  • Alabama
    • Alabaster, Alabama, United States, 35007
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35205-4785
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35213
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35294-2041
      • Pfizer Investigational Site
    • Hoover, Alabama, United States, 35216
      • Pfizer Investigational Site
    • Montgomery, Alabama, United States, 36117
      • Pfizer Investigational Site
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Pfizer Investigational Site
    • Mesa, Arizona, United States, 85206
      • Pfizer Investigational Site
  • California
    • Burbank, California, United States, 91505
      • Pfizer Investigational Site
    • Camp Pendleton, California, United States, 92055
      • Pfizer Investigational Site
    • Fresno, California, United States, 93703
      • Pfizer Investigational Site
    • La Jolla, California, United States, 92037
      • Pfizer Investigational Site
    • Loma Linda, California, United States, 92354
      • Pfizer Investigational Site
    • Los Angeles, California, United States, 90048
      • Pfizer Investigational Site
    • Los Angeles, California, United States, 90017-2395
      • Pfizer Investigational Site
    • Modesto, California, United States, 95350
      • Pfizer Investigational Site
    • Pasadena, California, United States, 91105
      • Pfizer Investigational Site
    • Rancho Mirage, California, United States, 92270
      • Pfizer Investigational Site
    • San Diego, California, United States, 92134-3303
      • Pfizer Investigational Site
    • San Francisco, California, United States, 94143-0130
      • Pfizer Investigational Site
    • San Francisco, California, United States, 94143-0326
      • Pfizer Investigational Site
    • Santa Rosa, California, United States, 95403
      • Pfizer Investigational Site
    • Stanford, California, United States
      • Pfizer Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80220
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80218
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80203
      • Pfizer Investigational Site
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Pfizer Investigational Site
    • Hartford, Connecticut, United States, 06102
      • Pfizer Investigational Site
    • New Britain, Connecticut, United States, 06053
      • Pfizer Investigational Site
  • Delaware
    • Newark, Delaware, United States, 19718
      • Pfizer Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Pfizer Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33756
      • Pfizer Investigational Site
    • Gainsville, Florida, United States, 32608
      • Pfizer Investigational Site
    • Gainsville, Florida, United States, 32610
      • Pfizer Investigational Site
    • Hollywood, Florida, United States, 33021
      • Pfizer Investigational Site
    • Inverness, Florida, United States, 34452
      • Pfizer Investigational Site
    • Lakeland, Florida, United States, 33805
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33173
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33176
      • Pfizer Investigational Site
    • Ocala, Florida, United States, 34474
      • Pfizer Investigational Site
    • Orlando, Florida, United States, 32803
      • Pfizer Investigational Site
    • Port Charlotte, Florida, United States, 33952
      • Pfizer Investigational Site
    • Sarasota, Florida, United States, 34239
      • Pfizer Investigational Site
    • Stuart, Florida, United States, 34996
      • Pfizer Investigational Site
    • Tamarac, Florida, United States, 33321
      • Pfizer Investigational Site
    • The Villages, Florida, United States, 32159
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Pfizer Investigational Site
    • Canton, Georgia, United States, 30114
      • Pfizer Investigational Site
  • Illinois
    • Berwyn, Illinois, United States, 60402
      • Pfizer Investigational Site
    • Blue Island, Illinois, United States, 60406
      • Pfizer Investigational Site
    • Chicago, Illinois, United States, 60611
      • Pfizer Investigational Site
    • Chicago, Illinois, United States, 60610
      • Pfizer Investigational Site
    • DuQuoin, Illinois, United States, 62832
      • Pfizer Investigational Site
    • Evanston, Illinois, United States, 60201
      • Pfizer Investigational Site
    • Lake Forest, Illinois, United States, 60045
      • Pfizer Investigational Site
    • Marion, Illinois, United States, 62959
      • Pfizer Investigational Site
    • Pekin, Illinois, United States, 61554
      • Pfizer Investigational Site
    • Peoria, Illinois, United States, 61603
      • Pfizer Investigational Site
    • Peoria, Illinois, United States, 61614
      • Pfizer Investigational Site
  • Indiana
    • Beech Grove, Indiana, United States, 46107
      • Pfizer Investigational Site
    • Evansville, Indiana, United States, 47710
      • Pfizer Investigational Site
    • Fort Wayne, Indiana, United States, 46805
      • Pfizer Investigational Site
    • Fort Wayne, Indiana, United States, 46825
      • Pfizer Investigational Site
    • Jeffersonville, Indiana, United States, 47130
      • Pfizer Investigational Site
    • Scottsburg, Indiana, United States, 47170
      • Pfizer Investigational Site
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Pfizer Investigational Site
    • Iowa City, Iowa, United States, 52242
      • Pfizer Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66160-7200
      • Pfizer Investigational Site
    • Lathe, Kansas, United States, 66061
      • Pfizer Investigational Site
    • Overland Park, Kansas, United States, 66213
      • Pfizer Investigational Site
    • Wichita, Kansas, United States, 67220
      • Pfizer Investigational Site
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Pfizer Investigational Site
    • Erlanger, Kentucky, United States, 41018
      • Pfizer Investigational Site
    • Louisville, Kentucky, United States, 40202
      • Pfizer Investigational Site
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Pfizer Investigational Site
    • New Orleans, Louisiana, United States, 70112
      • Pfizer Investigational Site
    • New Orleans, Louisiana, United States, 70121
      • Pfizer Investigational Site
  • Maine
    • Portland, Maine, United States, 04102
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Pfizer Investigational Site
    • Baltimore, Maryland, United States, 21205
      • Pfizer Investigational Site
    • Baltimore, Maryland, United States, 21287
      • Pfizer Investigational Site
    • Baltimore, Maryland, United States, 21201
      • Pfizer Investigational Site
    • Baltimore, Maryland, United States, 21204
      • Pfizer Investigational Site
    • Baltimore, Maryland, United States, 21208
      • Pfizer Investigational Site
    • Baltimore, Maryland, United States, 21224
      • Pfizer Investigational Site
    • Baltimore, Maryland, United States, 21228
      • Pfizer Investigational Site
    • Baltimore, Maryland, United States, 21229
      • Pfizer Investigational Site
    • Baltimore, Maryland, United States, 21237
      • Pfizer Investigational Site
    • Bel Air, Maryland, United States, 21014
      • Pfizer Investigational Site
    • Westminster, Maryland, United States, 21157
      • Pfizer Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Pfizer Investigational Site
    • Boston, Massachusetts, United States, 02215
      • Pfizer Investigational Site
    • Burlington, Massachusetts, United States, 1805
      • Pfizer Investigational Site
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Pfizer Investigational Site
    • Detroit, Michigan, United States, 48202
      • Pfizer Investigational Site
    • Farmington Hill, Michigan, United States, 48336
      • Pfizer Investigational Site
    • Sterling Heights, Michigan, United States, 48310
      • Pfizer Investigational Site
    • West Bloomfield, Michigan, United States, 48322
      • Pfizer Investigational Site
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Pfizer Investigational Site
    • Edina, Minnesota, United States, 55435
      • Pfizer Investigational Site
    • Maplewood, Minnesota, United States, 55109
      • Pfizer Investigational Site
    • Minneapolis, Minnesota, United States, 55455
      • Pfizer Investigational Site
    • St. Paul, Minnesota, United States, 55102
      • Pfizer Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Pfizer Investigational Site
    • St. Louis, Missouri, United States, 63110
      • Pfizer Investigational Site
    • St. Louis, Missouri, United States, 63141
      • Pfizer Investigational Site
    • St. Louis, Missouri, United States, 63104
      • Pfizer Investigational Site
    • St. Louis, Missouri, United States, 63110-0205
      • Pfizer Investigational Site
    • St. Louis, Missouri, United States, 63117
      • Pfizer Investigational Site
  • Nebraska
    • Papillion, Nebraska, United States, 68046
      • Pfizer Investigational Site
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Pfizer Investigational Site
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Pfizer Investigational Site
  • New York
    • Albany, New York, United States, 12208
      • Pfizer Investigational Site
    • Brooklyn, New York, United States, 11203
      • Pfizer Investigational Site
    • Hawthorne, New York, United States, 10535
      • Pfizer Investigational Site
    • Manlius, New York, United States, 13104
      • Pfizer Investigational Site
    • New York, New York, United States, 10021
      • Pfizer Investigational Site
    • New York, New York, United States, 10029
      • Pfizer Investigational Site
    • New York, New York, United States, 10032
      • Pfizer Investigational Site
    • Rochester, New York, United States, 14618
      • Pfizer Investigational Site
    • Rochester, New York, United States, 14607
      • Pfizer Investigational Site
    • Rochester, New York, United States, 14621
      • Pfizer Investigational Site
    • Syracuse, New York, United States, 13202
      • Pfizer Investigational Site
    • Syracuse, New York, United States, 13210
      • Pfizer Investigational Site
    • Valhalla, New York, United States, 10595
      • Pfizer Investigational Site
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Pfizer Investigational Site
    • Durham, North Carolina, United States, 27710
      • Pfizer Investigational Site
    • Eden, North Carolina, United States, 27288
      • Pfizer Investigational Site
    • Winston-Salem, North Carolina, United States, 27157
      • Pfizer Investigational Site
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45219
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45229
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45246
      • Pfizer Investigational Site
    • Cleveland, Ohio, United States, 44106-5038
      • Pfizer Investigational Site
    • Cleveland, Ohio, United States, 44195
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43210
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43221
      • Pfizer Investigational Site
    • Kettering, Ohio, United States, 45429-1221
      • Pfizer Investigational Site
    • Lorain, Ohio, United States, 44053
      • Pfizer Investigational Site
    • Sandusky, Ohio, United States, 44870
      • Pfizer Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74133
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74136-1920
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74136
      • Pfizer Investigational Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pfizer Investigational Site
    • Portland, Oregon, United States, 97210
      • Pfizer Investigational Site
    • Portland, Oregon, United States, 97216
      • Pfizer Investigational Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18102
      • Pfizer Investigational Site
    • Allentown, Pennsylvania, United States, 18106-0880
      • Pfizer Investigational Site
    • Lansdale, Pennsylvania, United States, 19446
      • Pfizer Investigational Site
    • Lehighton, Pennsylvania, United States, 18235
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Pfizer Investigational Site
    • Sellersville, Pennsylvania, United States, 18960
      • Pfizer Investigational Site
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Pfizer Investigational Site
    • Providence, Rhode Island, United States, 02906
      • Pfizer Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Pfizer Investigational Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Pfizer Investigational Site
    • Sioux Falls, South Dakota, United States, 57108
      • Pfizer Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Pfizer Investigational Site
    • Memphis, Tennessee, United States, 38105
      • Pfizer Investigational Site
    • Memphis, Tennessee, United States, 38119-5209
      • Pfizer Investigational Site
    • Memphis, Tennessee, United States, 38128
      • Pfizer Investigational Site
    • Nashville, Tennessee, United States, 37205
      • Pfizer Investigational Site
    • Nashville, Tennessee, United States, 37232-6300
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78756
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75246
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75235
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75390-9047
      • Pfizer Investigational Site
    • Denton, Texas, United States, 76204
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77030
      • Pfizer Investigational Site
    • Lackland AFB, Texas, United States, 78236-5300
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Pfizer Investigational Site
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Pfizer Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Pfizer Investigational Site
    • Richmond, Virginia, United States, 23298
      • Pfizer Investigational Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Pfizer Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53295
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General 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. doi: 10.1016/j.jacc.2006.07.041. Epub 2006 Oct 17.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 1998
• Primary Completion: December 7, 2022
• Study Completion: August 1, 2004

Study Registration Dates

• First Submitted: May 16, 2006
• First Submitted That Met QC Criteria: May 16, 2006
• First Posted (Estimate): May 18, 2006

Study Record Updates

• Last Update Posted (Estimate): May 3, 2007
• Last Update Submitted That Met QC Criteria: May 1, 2007
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: Revascularization; Major cardiovascular event; Major Coronary event
• Additional Relevant MeSH Terms: Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Stroke; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 0981-117; A2581136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No