Cardiovascular DiseasePhase 4TNTNCT00327691
A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels
A Phase 4 study testing Atorvastatin in people with Cardiovascular Disease and Cerebrovascular Accident, run by Pfizer at 314 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Cardiovascular Disease, Cerebrovascular Accident, Coronary Heart Disease
- What is being tested?
- Atorvastatin
- How many people
- 8,600 participants
- Where
- 314 sitesin 15 countries
- Study dates
- Apr 1998to Aug 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 35-75 who have evident CHD
Who cannot join
- Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary hyperlipidemia
Trial locations and contacts
314 sites in 15 countries.
314 sites in 15 countries
United States181 sites
Pfizer Investigational Site
Alabaster, Alabama, 35007
Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Allentown, Pennsylvania, 18102
Pfizer Investigational Site
Allentown, Pennsylvania, 18106-0880
Pfizer Investigational Site
Asheville, North Carolina, 28803
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Aurora, Colorado, 80012
Pfizer Investigational Site
Austin, Texas, 78756
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Baltimore, Maryland, 21204
Pfizer Investigational Site
Baltimore, Maryland, 21205
Pfizer Investigational Site
Baltimore, Maryland, 21208
Pfizer Investigational Site
Baltimore, Maryland, 21218
Pfizer Investigational Site
Baltimore, Maryland, 21224
Pfizer Investigational Site
Baltimore, Maryland, 21228
Pfizer Investigational Site
Baltimore, Maryland, 21229
Pfizer Investigational Site
Baltimore, Maryland, 21237
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Beachwood, Ohio, 44122
Pfizer Investigational Site
Beech Grove, Indiana, 46107
Pfizer Investigational Site
Bel Air, Maryland, 21014
Pfizer Investigational Site
Berwyn, Illinois, 60402
Pfizer Investigational Site
Birmingham, Alabama, 35205-4785
Pfizer Investigational Site
Birmingham, Alabama, 35213
Pfizer Investigational Site
Birmingham, Alabama, 35294-2041
Pfizer Investigational Site
Blue Island, Illinois, 60406
Pfizer Investigational Site
Boston, Massachusetts, 02111
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Bridgeport, Connecticut, 06610
Pfizer Investigational Site
Brooklyn, New York, 11203
Pfizer Investigational Site
Burbank, California, 91505
Pfizer Investigational Site
Burlington, Massachusetts, 1805
Pfizer Investigational Site
Burlington, Vermont, 05401
Pfizer Investigational Site
Camp Pendleton, California, 92055
Pfizer Investigational Site
Canton, Georgia, 30114
Pfizer Investigational Site
Charleston, South Carolina, 29403
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Chicago, Illinois, 60611
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45229
Pfizer Investigational Site
Cincinnati, Ohio, 45246
Pfizer Investigational Site
Clearwater, Florida, 33756
Pfizer Investigational Site
Cleveland, Ohio, 44106-5038
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Columbus, Ohio, 43221
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Dallas, Texas, 75390-9047
Pfizer Investigational Site
Dearborn, Michigan, 48126
Pfizer Investigational Site
Denton, Texas, 76204
Pfizer Investigational Site
Denver, Colorado, 80203
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Denver, Colorado, 80220
Pfizer Investigational Site
Des Moines, Iowa, 50314
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Du Quoin, Illinois, 62832
Pfizer Investigational Site
Duluth, Minnesota, 55805
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Eden, North Carolina, 27288
Pfizer Investigational Site
Edgewood, Kentucky, 41017
Pfizer Investigational Site
Edina, Minnesota, 55435
Pfizer Investigational Site
Erlanger, Kentucky, 41018
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Evanston, Illinois, 60201
Pfizer Investigational Site
Evansville, Indiana, 47710
Pfizer Investigational Site
Farmington Hill, Michigan, 48336
Pfizer Investigational Site
Fort Wayne, Indiana, 46805
Pfizer Investigational Site
Fort Wayne, Indiana, 46825
Pfizer Investigational Site
Fresno, California, 93703
Pfizer Investigational Site
Gainsville, Florida, 32608
Pfizer Investigational Site
Gainsville, Florida, 32610
Pfizer Investigational Site
Hartford, Connecticut, 06102
Pfizer Investigational Site
Hawthorne, New York, 10535
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Hoover, Alabama, 35216
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Inverness, Florida, 34452
Pfizer Investigational Site
Iowa City, Iowa, 52242
Pfizer Investigational Site
Jeffersonville, Indiana, 47130
Pfizer Investigational Site
Kansas City, Kansas, 66160-7200
Pfizer Investigational Site
Kansas City, Missouri, 64111
Pfizer Investigational Site
Kettering, Ohio, 45429-1221
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Lackland Air Force Base, Texas, 78236-5300
Pfizer Investigational Site
Lake Forest, Illinois, 60045
Pfizer Investigational Site
Lakeland, Florida, 33805
Pfizer Investigational Site
Lansdale, Pennsylvania, 19446
Pfizer Investigational Site
Lathe, Kansas, 66061
Pfizer Investigational Site
Lehighton, Pennsylvania, 18235
Pfizer Investigational Site
Loma Linda, California, 92354
Pfizer Investigational Site
Lorain, Ohio, 44053
Pfizer Investigational Site
Los Angeles, California, 90017-2395
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Manchester, New Hampshire, 03102
Pfizer Investigational Site
Manlius, New York, 13104
Pfizer Investigational Site
Maplewood, Minnesota, 55109
Pfizer Investigational Site
Marion, Illinois, 62959
Pfizer Investigational Site
Marrero, Louisiana, 70072
Pfizer Investigational Site
Memphis, Tennessee, 38104
Pfizer Investigational Site
Memphis, Tennessee, 38105
Pfizer Investigational Site
Memphis, Tennessee, 38119-5209
Pfizer Investigational Site
Memphis, Tennessee, 38128
Pfizer Investigational Site
Mesa, Arizona, 85202
Pfizer Investigational Site
Mesa, Arizona, 85206
Pfizer Investigational Site
Miami, Florida, 33173
Pfizer Investigational Site
Miami, Florida, 33176
Pfizer Investigational Site
Milwaukee, Wisconsin, 53295
Pfizer Investigational Site
Minneapolis, Minnesota, 55455
Pfizer Investigational Site
Modesto, California, 95350
Pfizer Investigational Site
Montgomery, Alabama, 36117
Pfizer Investigational Site
Nashville, Tennessee, 37205
Pfizer Investigational Site
Nashville, Tennessee, 37232-6300
Pfizer Investigational Site
New Britain, Connecticut, 06053
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New Orleans, Louisiana, 70112
Pfizer Investigational Site
New Orleans, Louisiana, 70121
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
New York, New York, 10029
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Newark, Delaware, 19718
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104
Pfizer Investigational Site
Orlando, Florida, 32803
Pfizer Investigational Site
Overland Park, Kansas, 66213
Pfizer Investigational Site
Papillion, Nebraska, 68046
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Pawtucket, Rhode Island, 02860
Pfizer Investigational Site
Pekin, Illinois, 61554
Pfizer Investigational Site
Peoria, Illinois, 61603
Pfizer Investigational Site
Peoria, Illinois, 61614
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Port Charlotte, Florida, 33952
Pfizer Investigational Site
Portland, Maine, 04102
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Portland, Oregon, 97216
Pfizer Investigational Site
Providence, Rhode Island, 02906
Pfizer Investigational Site
Rancho Mirage, California, 92270
Pfizer Investigational Site
Richmond, Virginia, 23249
Pfizer Investigational Site
Richmond, Virginia, 23298
Pfizer Investigational Site
Rochester, New York, 14607
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
Rochester, New York, 14621
Pfizer Investigational Site
Saint Paul, Minnesota, 55102
Pfizer Investigational Site
Salt Lake City, Utah, 84124
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92134-3303
Pfizer Investigational Site
San Francisco, California, 94143-0130
Pfizer Investigational Site
San Francisco, California, 94143-0326
Pfizer Investigational Site
Sandusky, Ohio, 44870
Pfizer Investigational Site
Santa Rosa, California, 95403
Pfizer Investigational Site
Sarasota, Florida, 34239
Pfizer Investigational Site
Scottsburg, Indiana, 47170
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960
Pfizer Investigational Site
Sioux Falls, South Dakota, 57105
Pfizer Investigational Site
Sioux Falls, South Dakota, 57108
Pfizer Investigational Site
St Louis, Missouri, 63104
Pfizer Investigational Site
St Louis, Missouri, 63110-0205
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
St Louis, Missouri, 63117
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Stanford, California
Pfizer Investigational Site
Sterling Heights, Michigan, 48310
Pfizer Investigational Site
Stuart, Florida, 34996
Pfizer Investigational Site
Syracuse, New York, 13202
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
Tamarac, Florida, 33321
Pfizer Investigational Site
The Villages, Florida, 32159
Pfizer Investigational Site
Tulsa, Oklahoma, 74133
Pfizer Investigational Site
Tulsa, Oklahoma, 74136-1920
Pfizer Investigational Site
Tulsa, Oklahoma, 74136
Pfizer Investigational Site
Valhalla, New York, 10595
Pfizer Investigational Site
Washington D.C., District of Columbia, 20037
Pfizer Investigational Site
West Bloomfield, Michigan, 48322
Pfizer Investigational Site
Westminster, Maryland, 21157
Pfizer Investigational Site
Wichita, Kansas, 67220
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157
Canada22 sites
Pfizer Investigational Site
Calgary, Alberta, T2E 7C5
Pfizer Investigational Site
Calgary, Alberta, T2N 4N1
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 5H6
Pfizer Investigational Site
Edmonton, Alberta, T5R 4H5
Pfizer Investigational Site
Edmonton, Alberta, T6G 2B7
Pfizer Investigational Site
Greater Sudbury, Ontario, P3E 1B8
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 3A7
Pfizer Investigational Site
Hamilton, Ontario, L8L 2X2
Pfizer Investigational Site
London, Ontario, N6A 4G5
Pfizer Investigational Site
Montreal, Quebec, H1T 1C8
Pfizer Investigational Site
Montreal, Quebec, H2W 1R7
Pfizer Investigational Site
Montreal, Quebec, H3A 1A1
Pfizer Investigational Site
Nanaimo, British Columbia, V9S 2B8
Pfizer Investigational Site
Ottawa, Ontario, K1Y 4W7
Pfizer Investigational Site
Québec, Quebec, G1R 2J6
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 5N4
Pfizer Investigational Site
St-foy, Quebec, G1V 4G2
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6
Pfizer Investigational Site
Toronto, Ontario, M5C 2T2
Pfizer Investigational Site
Vancouver, British Columbia, V6R 1Y6
Pfizer Investigational Site
Victoria, British Columbia, V8T 5G4
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9
United Kingdom17 sites
Pfizer Investigational Site
Aldershot, HAMPSHIRE, GU11 3RB
Pfizer Investigational Site
Barnet, EN5 3DJ
Pfizer Investigational Site
Blackpool, LANCASHIRE, FY3 8NR
Pfizer Investigational Site
Coventry, West Midlands, CV1 4FH
Pfizer Investigational Site
Coventry, WEST Midlands, CV2 2DX
Pfizer Investigational Site
Farnborough, KENT, BR6 7AR
Pfizer Investigational Site
Glasgow, G11 6NT
Pfizer Investigational Site
Leicester, LEICESTERSHIRE, LE3 9QP
Pfizer Investigational Site
London, GREATER LONDON, E2 9JX
Pfizer Investigational Site
London, GREATER LONDON, NW10 7NS
Pfizer Investigational Site
London, GREATER LONDON, SW17 0RE
Pfizer Investigational Site
London, MIDDLESEX, HA8 0AD
Pfizer Investigational Site
London, E1 1BB
Pfizer Investigational Site
London, NW3 2PF
Pfizer Investigational Site
Paisley, P1 1HR
Pfizer Investigational Site
Romford, ESSEX, RM7 OBE
Pfizer Investigational Site
Swindon, Wiltshire, SN3 6BB
Australia14 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Auchenflower, Queensland, 4066
Pfizer Investigational Site
Bedford Park, South Australia, 5042
Pfizer Investigational Site
Brisbane, Queensland, 4029
Pfizer Investigational Site
Chermside, Queensland, 4032
Pfizer Investigational Site
Clayton, Victoria, 3168
Pfizer Investigational Site
Greenslopes, Queensland, 4130
Pfizer Investigational Site
Herston, Queensland, 4029
Pfizer Investigational Site
Hobart, Tasmania, 7000
Pfizer Investigational Site
Milton, Queensland, 4064
Pfizer Investigational Site
Nedlands, Western Australia, 6009
Pfizer Investigational Site
Parkville, Victoria, 3050
Pfizer Investigational Site
Prahran, Victoria, 3181
Pfizer Investigational Site
St Leonards, New South Wales, 2065
Netherlands14 sites
Pfizer Investigational Site
's-Hertogenbosch, 5211 NL
Pfizer Investigational Site
Alkmaar, 1815 JD
Pfizer Investigational Site
Amersfoort, 3818 ES
Pfizer Investigational Site
Amsterdam, 1105 AZ
Pfizer Investigational Site
Breda, 4818 CK
Pfizer Investigational Site
Eindhoven, 5623 EJ
Pfizer Investigational Site
Enschede, 7513 ER
Pfizer Investigational Site
Groningen, 9713 GZ
Pfizer Investigational Site
Groningen, 9728 NZ
Pfizer Investigational Site
Leiden, 2333 ZA
Pfizer Investigational Site
Nieuwegein, 3435 CM
Pfizer Investigational Site
Nijmegen, 6532 SZ
Pfizer Investigational Site
Zwolle, 8011 JW
Pfizer Investigational Site
Zwolle, 8025 AB
France13 sites
Pfizer Investigational Site
Agen, 47000
Pfizer Investigational Site
Bordeaux, 33000
Pfizer Investigational Site
Brest, 29200
Pfizer Investigational Site
Clermont-Ferrand, 63003
Pfizer Investigational Site
Lyon, 69003
Pfizer Investigational Site
Marseille, 13915 Cedex 20
Pfizer Investigational Site
Paris, 75230
Pfizer Investigational Site
Pessac, Cedex, 33604
Pfizer Investigational Site
Rennes, 35033
Pfizer Investigational Site
Roubaix, 59056
Pfizer Investigational Site
Strasbourg, 67091
Pfizer Investigational Site
Toulouse, 31059
Pfizer Investigational Site
Toulouse, 31400
Spain13 sites
Pfizer Investigational Site
Barcelona, 08035
Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Córdoba, CORDOBA, 14004
Pfizer Investigational Site
Donostia / San Sebastian, 20014
Pfizer Investigational Site
Madrid, Madrid, 28007
Pfizer Investigational Site
Madrid, 28029
Pfizer Investigational Site
Madrid, 28040
Pfizer Investigational Site
Madrid, 28041
Pfizer Investigational Site
Santiago de Compostela, 15706
Pfizer Investigational Site
Seville, Sevilla, 41009
Pfizer Investigational Site
Seville, Sevilla, 41013
Pfizer Investigational Site
Valladolid, 47011
Pfizer Investigational Site
Zaragoza, 50009
Belgium8 sites
Pfizer Investigational Site
Aalst, 9300
Pfizer Investigational Site
Antwerp, B-2020
Pfizer Investigational Site
Genk, 3600
Pfizer Investigational Site
Genk, B-3600
Pfizer Investigational Site
Godinne, 5530
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Lommel, 3920
Pfizer Investigational Site
Neerpelt, 3910
Germany7 sites
Pfizer Investigational Site
Berlin, 13353
Pfizer Investigational Site
Berlin, 13439
Pfizer Investigational Site
Essen, 45329
Pfizer Investigational Site
Hamburg, 20246
Pfizer Investigational Site
Schwerte, D-58239
Pfizer Investigational Site
Tostedt, 21255
Pfizer Investigational Site
Würzburg, 97070
Italy7 sites
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Bologna, 40139
Pfizer Investigational Site
Cuneo, 12100
Pfizer Investigational Site
Florence, 50134
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Rome, 00184
Pfizer Investigational Site
Udine, 33100
South Africa6 sites
Pfizer Investigational Site
Bloemfontein, 9301
Pfizer Investigational Site
Cape Town, 7405
Pfizer Investigational Site
Cape Town, 7500
Pfizer Investigational Site
Johannesburg, Gauteng, 2193
Pfizer Investigational Site
Parow, 7505
Pfizer Investigational Site
Sunninghill, Gauteng, 2157
Switzerland5 sites
Pfizer Investigational Site
Bern, 3010
Pfizer Investigational Site
Geneva, CH-1211
Pfizer Investigational Site
Lausanne, CH-1011
Pfizer Investigational Site
Lugano, 6900
Pfizer Investigational Site
Sankt Gallen, CH-9007
Austria4 sites
Pfizer Investigational Site
Feldkirch, A-6807
Pfizer Investigational Site
Oberpullendorf, A-7350
Pfizer Investigational Site
Vienna, 1100
Pfizer Investigational Site
Vienna, A-1090
Ireland2 sites
Pfizer Investigational Site
Cork
Pfizer Investigational Site
Dublin, D8
Location not given1 site
Pfizer Investigational Site
About this 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
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.
- Being tested
- Atorvastatin
- Keywords
- Major cardiovascular event, Major Coronary event, Revascularization
- Medical subject headings
- Cardiovascular Diseases, Stroke, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (7)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startApr 1998
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 8,600 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327691
- Sponsor's protocol ID
- 0981-117
- Other IDs
- A2581136
- Acronym
- TNT
- Status last verified
- May 2007
- First submitted
- 16 May 2006
- Last updated
- 3 May 2007
- Results posted
- No
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.
PubMed 17084252Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
PubMed 38018702Vogt 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.
PubMed 31020900Bangalore 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.
PubMed 30571333Kaasenbrood 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.
PubMed 29622600Vallejo-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.
PubMed 29618599Ong 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.
PubMed 29358194Ports 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.
PubMed 28573499Bangalore 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.
PubMed 28379800Stam-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.
PubMed 28214794Deedwania 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.
PubMed 27513651Byun 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.
PubMed 25835440Arsenault 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.
PubMed 25531109Dorresteijn 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.
PubMed 23674398Semb 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.
PubMed 22576673
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00327691
- Acronym / sponsor ID
- TNT / 0981-117
- Keywords
- Major cardiovascular event, Major Coronary event, Revascularization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,600 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Study completion
- Aug 2004
- First posted
- 18 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women age 35-75 who have evident CHD
Key exclusion criteria (1 listed)
- Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary hyperlipidemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin | Drug | – |
Primary outcome
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
7 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2007.
- Results publication: PubMed 17084252Waters 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.
- Derived from this study: PubMed 38018702Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
- Derived from this study: PubMed 31020900Vogt 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.
- Derived from this study: PubMed 30571333Bangalore 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.
- Derived from this study: PubMed 29622600Kaasenbrood 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.
- Derived from this study: PubMed 29618599Vallejo-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.
- Derived from this study: PubMed 29358194Ong 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.
- Derived from this study: PubMed 28573499Ports 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.
- Derived from this study: PubMed 28379800Bangalore 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.
- Derived from this study: PubMed 28214794Stam-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.
- Derived from this study: PubMed 27513651Deedwania 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.
- Derived from this study: PubMed 25835440Byun 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
314 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Cardiovascular Disease and Cerebrovascular Accident, run by Pfizer at 314 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 314 sites in United States, Canada, United Kingdom, Australia, Netherlands and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the time to occurrence of a major. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00327691, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2007.