AzTrials
AzTrials

AtherosclerosisPhase 3STABILITYNCT00799903

The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial

A Phase 3 study testing Darapladib in people with Atherosclerosis, run by GlaxoSmithKline at 650 sites in 39 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerosis
What is being tested?
Darapladib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15,828 participants
Where
650 sitesin 39 countries
Study dates
1 Dec 2008to 17 Oct 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
  • Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.
  • Chronic coronary heart disease
  • At least one of the following:
  • At least 60 years old
  • Diabetes requiring treatment with medication
Show all 10Show fewer
  • Low HDL cholesterol ("good cholesterol")
  • Currently smoke cigarettes or stopped smoking within the past 3 months
  • Diagnosed mild or moderate reduction in kidney function
  • Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral arterial disease.

Who cannot join

  • Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.
  • Liver disease
  • Severe reduction in kidney function OR removal of a kidney OR kidney transplant
  • Severe heart failure
  • Blood pressure higher than normal despite lifestyle changes and treatment with medications
  • Any life-threatening disease expected to result in death within the next 2 years (other than heart disease)
Show all 13Show fewer
  • Severe asthma that is poorly controlled with medication
  • Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)
  • Previous severe allergic response to food, drink, insect stings, etc.
  • Drug or alcohol abuse within the past 6 months OR mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.
  • Certain medications that may interfere with the study medication (these will be identified by the study doctor)
  • Participation in a study of an investigational medication within the past 30 days
  • Current participation in a study of an investigational device

Trial locations and contacts

650 sites in 39 countries.

650 sites in 39 countries

United States155 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87102

  • GSK Investigational Site

    Amarillo, Texas, 79106

  • GSK Investigational Site

    Anchorage, Alaska, 99508

  • GSK Investigational Site

    Atlantis, Florida, 33462

  • GSK Investigational Site

    Auburn, Maine, 04210

  • GSK Investigational Site

    Aurora, Illinois, 60504

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Avon, Indiana, 46123

  • GSK Investigational Site

    Baltimore, Maryland, 21209

  • GSK Investigational Site

    Bangor, Maine, 04401

  • GSK Investigational Site

    Beaver, Pennsylvania, 15009

  • GSK Investigational Site

    Birmingham, Alabama, 35235

  • GSK Investigational Site

    Birmingham, Alabama, 35294-0007

  • GSK Investigational Site

    Boston, Massachusetts, 02111

  • GSK Investigational Site

    Bridgeport, Connecticut, 06606

  • GSK Investigational Site

    Bridgeport, Connecticut, 06610

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Browns Mills, New Jersey, 08015

  • GSK Investigational Site

    Buffalo, New York, 14215

  • GSK Investigational Site

    Burke, Virginia, 22015

  • GSK Investigational Site

    Cadillac, Michigan, 49601

  • GSK Investigational Site

    Charleston, South Carolina, 29401

  • GSK Investigational Site

    Charleston, South Carolina, 29425-6240

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Chicago, Illinois, 60654

  • GSK Investigational Site

    Cincinnati, Ohio, 45227

  • GSK Investigational Site

    Cincinnati, Ohio, 45246

  • GSK Investigational Site

    Colorado Springs, Colorado, 80920

  • GSK Investigational Site

    Concord, California, 94520

  • GSK Investigational Site

    Conyers, Georgia, 30094

  • GSK Investigational Site

    Corpus Christi, Texas, 78404

  • GSK Investigational Site

    Crestview Hills, Kentucky, 41017

  • GSK Investigational Site

    Dallas, Texas, 75226

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Danville, Pennsylvania, 17822-4201

  • GSK Investigational Site

    Denver, Colorado, 80218

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    Doylestown, Pennsylvania, 18901

  • GSK Investigational Site

    Draper, Utah, 84020

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Elizabeth, New Jersey, 07202

  • GSK Investigational Site

    Elyria, Ohio, 44035

  • GSK Investigational Site

    Erie, Pennsylvania, 16502

  • GSK Investigational Site

    Franklin, Indiana, 46131

  • GSK Investigational Site

    Gainesville, Florida, 32610

  • GSK Investigational Site

    Garfield Heights, Ohio, 44125

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Georgetown, Texas, 78626

  • GSK Investigational Site

    Golden, Colorado, 80401

  • GSK Investigational Site

    Grand Forks, North Dakota, 58201

  • GSK Investigational Site

    Grand Island, Nebraska, 68803

  • GSK Investigational Site

    Greenfield, Indiana, 46140

  • GSK Investigational Site

    Harker Heights, Texas, 76548

  • GSK Investigational Site

    Hartford, Connecticut, 06067

  • GSK Investigational Site

    Hollywood, Florida, 33023

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77081

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Indianapolis, Indiana, 46256

  • GSK Investigational Site

    Indianapolis, Indiana, 46260

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Jacksonville, Florida, 32207

  • GSK Investigational Site

    Jacksonville, Florida, 32216

  • GSK Investigational Site

    Jacksonville, Florida, 32258

  • GSK Investigational Site

    Jacksonville Beach, Florida, 32250

  • GSK Investigational Site

    Jersey Shore, Pennsylvania, 17740

  • GSK Investigational Site

    Johnson City, Tennessee, 37601

  • GSK Investigational Site

    Kettering, Ohio, 45429

  • GSK Investigational Site

    Kirkland, Washington, 98034

  • GSK Investigational Site

    Lafayette, Louisiana, 70503

  • GSK Investigational Site

    Las Vegas, Nevada, 89103

  • GSK Investigational Site

    Las Vegas, Nevada, 89130

  • GSK Investigational Site

    Lewistown, Pennsylvania, 17044

  • GSK Investigational Site

    Little Rock, Arkansas, 72204

  • GSK Investigational Site

    Lomita, California, 90717

  • GSK Investigational Site

    Los Angeles, California, 90024

  • GSK Investigational Site

    Los Angeles, California, 90036

  • GSK Investigational Site

    Louisville, Kentucky, 40206

  • GSK Investigational Site

    Louisville, Kentucky, 40213

  • GSK Investigational Site

    Madera, California, 93637

  • GSK Investigational Site

    Matthews, North Carolina, 28105

  • GSK Investigational Site

    Melrose Park, Illinois, 60160

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Miami, Florida, 33183

  • GSK Investigational Site

    Middleburg Heights, Ohio, 44130

  • GSK Investigational Site

    Natick, Massachusetts, 01760

  • GSK Investigational Site

    New Iberia, Louisiana, 70563

  • GSK Investigational Site

    New York, New York, 10001

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    New York, New York, 10021

  • GSK Investigational Site

    Newark, Delaware, 19718

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Oakland, California, 94611

  • GSK Investigational Site

    Oakland, California, 94612

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73120

  • GSK Investigational Site

    Olympia, Washington, 98502

  • GSK Investigational Site

    Oxon Hill, Maryland, 20745

  • GSK Investigational Site

    Petoskey, Michigan, 49770

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Philipsburg, Pennsylvania, 16866

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Plano, Texas, 75024

  • GSK Investigational Site

    Ponte Vedra Beach, Florida, 32081

  • GSK Investigational Site

    Port Matilda, Pennsylvania, 16870

  • GSK Investigational Site

    Portland, Oregon, 97219

  • GSK Investigational Site

    Poway, California, 92064

  • GSK Investigational Site

    Prince Frederick, Maryland, 20678

  • GSK Investigational Site

    Providence, Rhode Island, 02904

  • GSK Investigational Site

    Rapid City, South Dakota, 57701

  • GSK Investigational Site

    Renton, Washington, 98057

  • GSK Investigational Site

    Richmond, Virginia, 23294

  • GSK Investigational Site

    Sacramento, California, 95819

  • GSK Investigational Site

    Saint Cloud, Minnesota, 56303

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • GSK Investigational Site

    San Antonio, Texas, 78217

  • GSK Investigational Site

    San Antonio, Texas, 78244

  • GSK Investigational Site

    San Diego, California, 92161

  • GSK Investigational Site

    San Ramon, California, 94582

  • GSK Investigational Site

    Sandusky, Ohio, 44870

  • GSK Investigational Site

    Santa Ana, California, 92705

  • GSK Investigational Site

    Sayre, Pennsylvania, 18840

  • GSK Investigational Site

    Scarborough, Maine, 04074

  • GSK Investigational Site

    Scranton, Pennsylvania, 18503

  • GSK Investigational Site

    Scranton, Pennsylvania, 18505

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    Sellersville, Pennsylvania, 18960

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57105

  • GSK Investigational Site

    Slidell, Louisiana, 70458

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Spokane, Washington, 99207

  • GSK Investigational Site

    Spokane, Washington, 99208

  • GSK Investigational Site

    Spring Valley, California, 91978

  • GSK Investigational Site

    Springfield, Massachusetts, 01103

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Statesville, North Carolina, 28677

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Thornton, Colorado, 80229

  • GSK Investigational Site

    Thousand Oaks, California, 91360

  • GSK Investigational Site

    Toledo, Ohio, 43614

  • GSK Investigational Site

    Valparaiso, Indiana, 46383

  • GSK Investigational Site

    Victoria, Texas, 77901

  • GSK Investigational Site

    Walla Walla, Washington, 99362

  • GSK Investigational Site

    Wausau, Wisconsin, 54401

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    West Des Moines, Iowa, 50266

  • GSK Investigational Site

    West Orange, New Jersey, 07052

  • GSK Investigational Site

    Westfield, New York, 14787

  • GSK Investigational Site

    Westlake, Ohio, 44145

  • GSK Investigational Site

    Wilkes-Barre, Pennsylvania, 18702

  • GSK Investigational Site

    Williamsville, New York, 14221

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

  • GSK Investigational Site

    Winchester, Virginia, 22601

  • GSK Investigational Site

    York, Pennsylvania, 17403

Other trials in United States

Germany45 sites

  • GSK Investigational Site

    Aschaffenburg, Bavaria, 63739

  • GSK Investigational Site

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10559

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 13055

  • GSK Investigational Site

    Berlin, 13086

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Berlin, 13347

  • GSK Investigational Site

    Berlin, 13353

  • GSK Investigational Site

    Berlin, 13405

  • GSK Investigational Site

    Bernau bei Berlin, Brandenburg, 16321

  • GSK Investigational Site

    Deggingen, Baden-Wurttemberg, 73326

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Dorsten, North Rhine-Westphalia, 46282

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Eschweiler, North Rhine-Westphalia, 52249

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Frankfurt/M., Hesse, 60594

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Güglingen, Baden-Wurttemberg, 74363

  • GSK Investigational Site

    Haag, Bavaria, 83527

  • GSK Investigational Site

    Hamburg, 22041

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • GSK Investigational Site

    Herford, North Rhine-Westphalia, 32049

  • GSK Investigational Site

    Höhenkirchen-Siegertsbrunn, Bavaria, 85635

  • GSK Investigational Site

    Kelkheim, Hesse, 65779

  • GSK Investigational Site

    Künzing, Bavaria, 94550

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04315

  • GSK Investigational Site

    Leipzig, Saxony, 04329

  • GSK Investigational Site

    Lienen-Kattenvenne, North Rhine-Westphalia, 49536

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Mühldorf, Bavaria, 84453

  • GSK Investigational Site

    Munich, Bavaria, 80336

  • GSK Investigational Site

    Rhaunen, Rhineland-Palatinate, 55624

  • GSK Investigational Site

    Schmiedeberg, Saxony, 01762

  • GSK Investigational Site

    Sulzbach-Rosenberg, Bavaria, 92237

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89081

  • GSK Investigational Site

    Wallerfing, Bavaria, 94574

  • GSK Investigational Site

    Weyhe-Leeste, Lower Saxony, 28844

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58455

Other trials in Germany

Canada33 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 7K8

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Brampton, Ontario, L6Z 4N5

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2B7

  • GSK Investigational Site

    Gatineau, Quebec, J8Y 6S8

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 3A7

  • GSK Investigational Site

    Hamilton, Ontario, L8L 2X2

  • GSK Investigational Site

    Kelowna, British Columbia, V1Y 1E4

  • GSK Investigational Site

    Kitchener, Ontario, N2M 5N6

  • GSK Investigational Site

    Lévis, Quebec, G6V 4Z5

  • GSK Investigational Site

    Mississauga, Ontario, L5B 2P7

  • GSK Investigational Site

    Montreal, Quebec, H1T 1C8

  • GSK Investigational Site

    Montreal, Quebec, H1T 3Y7

  • GSK Investigational Site

    New Westminster, British Columbia, V3L 3W4

  • GSK Investigational Site

    Oshawa, Ontario, L1J 2J9

  • GSK Investigational Site

    Ottawa, Ontario, K1Y 4W7

  • GSK Investigational Site

    Québec, Quebec, G1J 1Z6

  • GSK Investigational Site

    Québec, Quebec, G1L 3L5

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • GSK Investigational Site

    Scarborough Village, Ontario, M1E 5E9

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 2E3

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • GSK Investigational Site

    Surrey, British Columbia, V3V 1N1

  • GSK Investigational Site

    Thornhill, Ontario, L4J 8L7

  • GSK Investigational Site

    Toronto, Ontario, M3H 5S4

  • GSK Investigational Site

    Toronto, Ontario, M4G 3E8

  • GSK Investigational Site

    Toronto, Ontario, M5C 2T2

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • GSK Investigational Site

    Victoria, British Columbia, V8R 4R2

  • GSK Investigational Site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

France21 sites

  • GSK Investigational Site

    Aix-en-Provence, 13616

  • GSK Investigational Site

    Avignon, 84082

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Bron, 69677

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Marseille, 13385

  • GSK Investigational Site

    Metz, 57085

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Narbonne, 11108

  • GSK Investigational Site

    Nîmes, 30000

  • GSK Investigational Site

    Paris, 75010

  • GSK Investigational Site

    Paris, 75015

  • GSK Investigational Site

    Paris, 75651

  • GSK Investigational Site

    Paris, 75877

  • GSK Investigational Site

    Pessac, 33604

  • GSK Investigational Site

    Roubaix, 59056

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Tourcoing, 59208

Other trials in France

Russia21 sites

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Kemerovo, 650055

  • GSK Investigational Site

    Moscow, 111020

  • GSK Investigational Site

    Moscow, 111539

  • GSK Investigational Site

    Moscow, 117292

  • GSK Investigational Site

    Moscow, 119620

  • GSK Investigational Site

    Moscow, 121 552

  • GSK Investigational Site

    Moscow, 121552

  • GSK Investigational Site

    Novosibirsk, 630003

  • GSK Investigational Site

    Novosibirsk, 630008

  • GSK Investigational Site

    Novosibirsk, 630047

  • GSK Investigational Site

    Ryazan, 390026

  • GSK Investigational Site

    S.-Petresburg, 195067

  • GSK Investigational Site

    Saint Pertersburg, 196247

  • GSK Investigational Site

    Saint Petersburg, 193312

  • GSK Investigational Site

    Saint Petersburg, 195067

  • GSK Investigational Site

    Saint Petersburg, 199106

  • GSK Investigational Site

    St'Petersburg, 194156

  • GSK Investigational Site

    Yekaterinburg, 620109

  • GSK Investigational Site

    Yekaterinburg, 620144

  • GSK Investigational Site

    Yekaterinburg

Other trials in Russia

Spain21 sites

  • GSK Investigational Site

    Alicante, 03114

  • GSK Investigational Site

    Granada, 18012

  • GSK Investigational Site

    Jerez de la Frontera, 11407

  • GSK Investigational Site

    Madrid, 28029

  • GSK Investigational Site

    Madrid, 28031

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Madrid

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Marid, 28040

  • GSK Investigational Site

    Oviedo, 33006

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    San Juan (Alicante), 03550

  • GSK Investigational Site

    San Sebastián, 20014

  • GSK Investigational Site

    San Sebastián de Los Reyes/Madrid

  • GSK Investigational Site

    Santa Coloma de Gramanet (Barcelona), 08923

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Seville, 41071

  • GSK Investigational Site

    Valdemoro/Madrid, 28340

Other trials in Spain

Japan19 sites

  • GSK Investigational Site

    Aichi, 487-0013

  • GSK Investigational Site

    Chiba, 270-2251

  • GSK Investigational Site

    Fukuoka, 802-8555

  • GSK Investigational Site

    Fukuoka, 811-3195

  • GSK Investigational Site

    Fukuoka, 819-1104

  • GSK Investigational Site

    Hokkaido, 063-0005

  • GSK Investigational Site

    Hokkaido, 065-0033

  • GSK Investigational Site

    Kagoshima, 892-0853

  • GSK Investigational Site

    Kanagawa, 240-0116

  • GSK Investigational Site

    Kanagawa, 247-8533

  • GSK Investigational Site

    Kyoto, 611-0042

  • GSK Investigational Site

    Nagano, 386-8610

  • GSK Investigational Site

    Nagasaki, 856-8562

  • GSK Investigational Site

    Nagasaki, 859-3615

  • GSK Investigational Site

    Ōita, 870-1133

  • GSK Investigational Site

    Osaka, 574-0074

  • GSK Investigational Site

    Shiga, 520-2192

  • GSK Investigational Site

    Shizuoka, 411-8611

  • GSK Investigational Site

    Tokyo, 141-0001

Other trials in Japan

Argentina18 sites

  • GSK Investigational Site

    Adrogué, Buenos Aires, B1846DSK

  • GSK Investigational Site

    Bahía Blanca, Buenos Aires, B8000FTD

  • GSK Investigational Site

    Buenos Aires, 1425

  • GSK Investigational Site

    CABA, Buenos Aires, C1124AAJ

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1125ABD

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1437JCP

  • GSK Investigational Site

    Córdoba, Córdoba Province, X5000EPU

  • GSK Investigational Site

    Corrientes, W3400AMZ

  • GSK Investigational Site

    Corrientes, W3400CLH

  • GSK Investigational Site

    Junín, Buenos Aires

  • GSK Investigational Site

    La Plata, Buenos Aires, B1900AXI

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, B7600FZN

  • GSK Investigational Site

    Mendoza, M5500CCG

  • GSK Investigational Site

    Ramos Mejía, Buenos Aires, B1704ETD

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000CVD

  • GSK Investigational Site

    San Miguel de Tucumán, T4000ICL

  • GSK Investigational Site

    Santa Fe, 3000

Other trials in Argentina

Poland18 sites

  • GSK Investigational Site

    Bydgoszcz, 85-079

  • GSK Investigational Site

    Bydgoszcz, 85-435

  • GSK Investigational Site

    Gdynia, 81-423

  • GSK Investigational Site

    Kowanówko

  • GSK Investigational Site

    Krakow, 31-202

  • GSK Investigational Site

    Mielec, 39-300

  • GSK Investigational Site

    Ostrów Wielkopolski, 63-400

  • GSK Investigational Site

    Płońsk, 09 - 100

  • GSK Investigational Site

    Radom, 26-617

  • GSK Investigational Site

    Ruda Śląska, 41-706

  • GSK Investigational Site

    Siemianowice Śląskie, 41-100

  • GSK Investigational Site

    Skierniewice

  • GSK Investigational Site

    Torun, 87-100

  • GSK Investigational Site

    Tychy, 43-100

  • GSK Investigational Site

    Warsaw, 03-285

  • GSK Investigational Site

    Warsaw, 04-073

  • GSK Investigational Site

    Włocławek, 87-800

  • GSK Investigational Site

    Wroclaw, 50-349

Other trials in Poland

Brazil17 sites

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30150-221.

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30380090

  • GSK Investigational Site

    Campinas, São Paulo, 13059740

  • GSK Investigational Site

    Curitiba, Paraná, 80730150

  • GSK Investigational Site

    Goiânia, Goiás, 74605-050

  • GSK Investigational Site

    Natal, Rio Grande do Norte, 59020-100

  • GSK Investigational Site

    Pelotas, Rio Grande do Sul, 96015-290

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90610000

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90880-480

  • GSK Investigational Site

    Rio de Janeiro, 20551-030

  • GSK Investigational Site

    Salvador, Estado de Bahia, 41810010

  • GSK Investigational Site

    São José do Rio Preto, São Paulo, 15015210

  • GSK Investigational Site

    São José do Rio Preto, São Paulo, 15090-000

  • GSK Investigational Site

    São Paulo, 04012-909

  • GSK Investigational Site

    São Paulo, 04012180

  • GSK Investigational Site

    São Paulo, 05403-000

  • GSK Investigational Site

    São Paulo, 05403000

Other trials in Brazil

United Kingdom17 sites

  • GSK Investigational Site

    Barnet, EN5 3DJ

  • GSK Investigational Site

    Cambridge, Cambridgeshire, CB2 0QQ

  • GSK Investigational Site

    Chelsea, London, SW3 6NP

  • GSK Investigational Site

    Chertsey, Surrey, KT16 0PZ

  • GSK Investigational Site

    Chichester, Sussex West, PO19 4SE

  • GSK Investigational Site

    Coatbridge, ML5 3AP

  • GSK Investigational Site

    Cottingham, HU16 5JQ

  • GSK Investigational Site

    Cumbernauld, G67 1BJ

  • GSK Investigational Site

    Glasgow, Lanarkshire, G11 6NT

  • GSK Investigational Site

    Hamilton, ML3 8AA

  • GSK Investigational Site

    Harrow, Middlesex, HA1 3UJ

  • GSK Investigational Site

    Hertfordshire

  • GSK Investigational Site

    Liverpool, Merseyside

  • GSK Investigational Site

    Liverpool, L7 8XP

  • GSK Investigational Site

    Motherwell, Lanarkshire, ML1 3JX

  • GSK Investigational Site

    Newcastle upon Tyne, NE7 7DN

  • GSK Investigational Site

    Paisley, PA2 9PN

Other trials in United Kingdom

Australia16 sites

  • GSK Investigational Site

    Auchenflower, Queensland, 4066

  • GSK Investigational Site

    Ballarat, Victoria

  • GSK Investigational Site

    Bedford Park, South Australia, 5042

  • GSK Investigational Site

    Caulfield South, Victoria, 3162

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

  • GSK Investigational Site

    Concord, New South Wales, 2139

  • GSK Investigational Site

    Frankston, Victoria, 3199

  • GSK Investigational Site

    Fremantle, Western Australia, 6160

  • GSK Investigational Site

    Garran, Australian Capital Territory, 2606

  • GSK Investigational Site

    Gosford, New South Wales, 2250

  • GSK Investigational Site

    Joondalup, Western Australia, 6027

  • GSK Investigational Site

    Kippa-Ring, Queensland, 4021

  • GSK Investigational Site

    Liverpool, New South Wales, 2170

  • GSK Investigational Site

    Malvern, Victoria, 3144

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Sherwood, Queensland, 4075

Other trials in Australia

China16 sites

  • GSK Investigational Site

    Beijing, 100034

  • GSK Investigational Site

    Beijing, 100044

  • GSK Investigational Site

    Beijing, 100730

  • GSK Investigational Site

    Beijing, 100853

  • GSK Investigational Site

    Guangzhou, Guangdong, 510080

  • GSK Investigational Site

    Guangzhou, 510100

  • GSK Investigational Site

    Haerbin, 150001

  • GSK Investigational Site

    Hangzhou, Zhejiang, 310003

  • GSK Investigational Site

    Jinan, Shandong, 250012

  • GSK Investigational Site

    Nanjing, Jiangsu, 210029

  • GSK Investigational Site

    Shanghai, 200032

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Shanghai, 200127

  • GSK Investigational Site

    Shanghai, 200233

  • GSK Investigational Site

    Wuhan, 430022

  • GSK Investigational Site

    Xi'an, Shaanxi, 710061

Other trials in China

Czechia15 sites

  • GSK Investigational Site

    Čáslav, 286 01

  • GSK Investigational Site

    Chomutov, 430 02

  • GSK Investigational Site

    Chrudim, 537 27

  • GSK Investigational Site

    Jihlava, 586 33

  • GSK Investigational Site

    Kladno, 272 80

  • GSK Investigational Site

    Kolín, 280 00

  • GSK Investigational Site

    Kroměříž, 767 55

  • GSK Investigational Site

    Milevsko, 399 01

  • GSK Investigational Site

    Písek, 397 01

  • GSK Investigational Site

    Prague, 128 08

  • GSK Investigational Site

    Příbram, 261 26

  • GSK Investigational Site

    Slaný

  • GSK Investigational Site

    Svitavy, 568 25

  • GSK Investigational Site

    Tábor, 390 03

  • GSK Investigational Site

    Ústí nad Orlicí, 562 18

Other trials in Czechia

South Korea15 sites

  • GSK Investigational Site

    Cheongju-si, 361-711

  • GSK Investigational Site

    Daegu, 700-721

  • GSK Investigational Site

    Gangnam-gu, Seoul, 135-710

  • GSK Investigational Site

    Gwangju, 501-757

  • GSK Investigational Site

    Jeonju-si, Jeollabuk-Do, 561-712

  • GSK Investigational Site

    Seo-gu Busan, 602-739

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 463-707

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 130-702

  • GSK Investigational Site

    Seoul, 136-705

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Seoul, 143-729

  • GSK Investigational Site

    Uijeongbu-si Kyonggi-do, 480-717

Other trials in South Korea

India14 sites

  • GSK Investigational Site

    Ahmedabad, 380060

  • GSK Investigational Site

    Bangalore, 560 099

  • GSK Investigational Site

    Bangalore, 560034

  • GSK Investigational Site

    Jaipur, 302001

  • GSK Investigational Site

    Jaipur, 302017

  • GSK Investigational Site

    Kochi, 683572

  • GSK Investigational Site

    Mysore, 570020

  • GSK Investigational Site

    New Delhi, 110060

  • GSK Investigational Site

    Patiāla, 147001

  • GSK Investigational Site

    Pune, 411004

  • GSK Investigational Site

    Pune, 411030

  • GSK Investigational Site

    Saket,Delhi, 110017

  • GSK Investigational Site

    Vadodara, 390015

  • GSK Investigational Site

    Vijayawada, 520008

Other trials in India

Netherlands14 sites

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Beverwijk, 1942 LE

  • GSK Investigational Site

    Doetinchem, 7009 BL

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Enschede, 7513 ER

  • GSK Investigational Site

    Goes, 4462 RA

  • GSK Investigational Site

    Harderwijk, 3844 DG

  • GSK Investigational Site

    Hoofddorp, 2134 TM

  • GSK Investigational Site

    Leeuwarden, 8934 AD

  • GSK Investigational Site

    Rotterdam, 3079 DZ

  • GSK Investigational Site

    Sittard-geleen, 6162 BG

  • GSK Investigational Site

    Sneek, 8601 ZK

  • GSK Investigational Site

    The Hague, 2597 AX

  • GSK Investigational Site

    Tiel, 4002 WP

Other trials in Netherlands

South Africa14 sites

  • GSK Investigational Site

    Bellville, 7531

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Kempton Park, 1619

  • GSK Investigational Site

    Kuils River, 7580

  • GSK Investigational Site

    Moreletapark, 0181

  • GSK Investigational Site

    Olivedale, 2188

  • GSK Investigational Site

    Paarl, 7646

  • GSK Investigational Site

    Parktown, Gauteng, 2193

  • GSK Investigational Site

    Parktown West, 2193

  • GSK Investigational Site

    Parow, 7505

  • GSK Investigational Site

    Pinelands, 7405

  • GSK Investigational Site

    Somerset West, 7130

  • GSK Investigational Site

    Soweto, 2013

  • GSK Investigational Site

    Umhlanga, 4319

Other trials in South Africa

Sweden14 sites

  • GSK Investigational Site

    Eksjö, SE-575 36

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Gothenburg, SE-416 85

  • GSK Investigational Site

    Linköping, SE-581 85

  • GSK Investigational Site

    Lund, SE-222 21

  • GSK Investigational Site

    Malmö, SE-205 02

  • GSK Investigational Site

    Östersund, SE-831 83

  • GSK Investigational Site

    Stockholm, SE-111 35

  • GSK Investigational Site

    Stockholm, SE-111 57

  • GSK Investigational Site

    Stockholm, SE-182 88

  • GSK Investigational Site

    Umeå, SE-901 85

  • GSK Investigational Site

    Uppsala, SE-751 85

  • GSK Investigational Site

    Västerås, SE-721 89

  • GSK Investigational Site

    Västervik, SE-593 81

Other trials in Sweden

Ukraine13 sites

  • GSK Investigational Site

    Donetsk, 83045

  • GSK Investigational Site

    Kharkiv, 61002

  • GSK Investigational Site

    Kharkiv, 61018

  • GSK Investigational Site

    Kharkiv, 61037

  • GSK Investigational Site

    Kharkiv, 61176

  • GSK Investigational Site

    Kyiv, 02660

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Kyiv, 04114

  • GSK Investigational Site

    Lviv, 79044

  • GSK Investigational Site

    Odesa, 65025

  • GSK Investigational Site

    Odesa, 65114

  • GSK Investigational Site

    Vinnytsia, 21029

  • GSK Investigational Site

    Zaporizhzhya, 69118

Other trials in Ukraine

Hungary12 sites

  • GSK Investigational Site

    Berettyóújfalu

  • GSK Investigational Site

    Budapest, 1032

  • GSK Investigational Site

    Budapest, 1033

  • GSK Investigational Site

    Budapest, 1096

  • GSK Investigational Site

    Esztergom

  • GSK Investigational Site

    Gyula, 5700

  • GSK Investigational Site

    Komárom, 2921

  • GSK Investigational Site

    Mosonmagyaróvár, 9200

  • GSK Investigational Site

    Sátoraljaújhely, 3980

  • GSK Investigational Site

    Székesfehérvár, 8000

  • GSK Investigational Site

    Szikszó

  • GSK Investigational Site

    Szolnok, 5004

Other trials in Hungary

Italy12 sites

  • GSK Investigational Site

    Ascoli Piceno, The Marches, 63100

  • GSK Investigational Site

    Carpi, Emilia-Romagna, 41012

  • GSK Investigational Site

    Chieti, Abruzzo, 66013

  • GSK Investigational Site

    Cona (Ferrara), Emilia-Romagna, 44124

  • GSK Investigational Site

    Cuneo, Piedmont, 12100

  • GSK Investigational Site

    Milan, Lombardy, 20162

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Novara, Piedmont, 28100

  • GSK Investigational Site

    Parma, Emilia-Romagna, 43100

  • GSK Investigational Site

    Pisa, Tuscany, 56126

  • GSK Investigational Site

    Rome, Lazio, 00135

  • GSK Investigational Site

    Treviso, Veneto, 31100

Other trials in Italy

New Zealand12 sites

  • GSK Investigational Site

    Christchurch

  • GSK Investigational Site

    Dunedin

  • GSK Investigational Site

    Grafton, Auckland, 1030

  • GSK Investigational Site

    Hamilton, 3204

  • GSK Investigational Site

    Lower Hutt

  • GSK Investigational Site

    Nelson

  • GSK Investigational Site

    Otahuhu, Auckland, 1640

  • GSK Investigational Site

    Palmerston North, 4410

  • GSK Investigational Site

    Takapuna, Auckland, 0622

  • GSK Investigational Site

    Tauranga, 3112

  • GSK Investigational Site

    Timaru, 7910

  • GSK Investigational Site

    Whangarei

Other trials in New Zealand

Belgium11 sites

  • GSK Investigational Site

    Aalst, 9300

  • GSK Investigational Site

    Antwerp, 2020

  • GSK Investigational Site

    Bonheiden, 2820

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Genk, 3600

  • GSK Investigational Site

    Hasselt, 3500

  • GSK Investigational Site

    La Louvière, 7100

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

  • GSK Investigational Site

    Roeselaere, 8800

  • GSK Investigational Site

    Yvoir, 5530

Other trials in Belgium

Greece11 sites

  • GSK Investigational Site

    Agia Varvara, Athens, 123 51

  • GSK Investigational Site

    Alexandroupoli, 68100

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Athens, 124 62

  • GSK Investigational Site

    Athens, 176 74

  • GSK Investigational Site

    Chalcis, 341 00

  • GSK Investigational Site

    Ioannina, 45500

  • GSK Investigational Site

    Magoula, Elefsina, 192 00

  • GSK Investigational Site

    Pátrai, 26 500

  • GSK Investigational Site

    Thessaloniki, 546 42

  • GSK Investigational Site

    Voula / Athens, 166 73

Other trials in Greece

Bulgaria10 sites

  • GSK Investigational Site

    Dimitrovgrad, 6400

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Plovdiv, 4003

  • GSK Investigational Site

    Rousse, 7002

  • GSK Investigational Site

    Sofia, 1000

  • GSK Investigational Site

    Sofia, 1233

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Sofia, 1527

  • GSK Investigational Site

    Sofia, 1606

  • GSK Investigational Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Romania10 sites

  • GSK Investigational Site

    Bucharest, 011461

  • GSK Investigational Site

    Bucharest, 011601

  • GSK Investigational Site

    Bucharest, 011794

  • GSK Investigational Site

    Bucharest, 022328

  • GSK Investigational Site

    Bucharest, 041915

  • GSK Investigational Site

    Bucharest, 042122

  • GSK Investigational Site

    Bucharest, 050098

  • GSK Investigational Site

    Deva, 330084

  • GSK Investigational Site

    Galati, 800087

  • GSK Investigational Site

    Târgu Mureş, 540136

Other trials in Romania

Chile8 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 750 0922

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500503

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7571831

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 833 0074

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8360160

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8380456

  • GSK Investigational Site

    Talcahuano, Región Del Biobio, 427 0918

  • GSK Investigational Site

    Viña del Mar, Valparaiso

Other trials in Chile

Pakistan7 sites

  • GSK Investigational Site

    Karachi, 75510

  • GSK Investigational Site

    Karachi, 75950

  • GSK Investigational Site

    Korangi / Karachi

  • GSK Investigational Site

    Lahore, 54000

  • GSK Investigational Site

    Lahore

  • GSK Investigational Site

    Multan, 60000

  • GSK Investigational Site

    Rawalpindi Cantt, 46000

Other trials in Pakistan

Philippines7 sites

  • GSK Investigational Site

    Ermita, Manila, 1000

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Manila, 1100

  • GSK Investigational Site

    Quezon City, 1109

  • GSK Investigational Site

    Quezon City, 1113

  • GSK Investigational Site

    Quezon City

  • GSK Investigational Site

    San Juan City, 1502

Other trials in Philippines

Taiwan6 sites

  • GSK Investigational Site

    Changhua, 500

  • GSK Investigational Site

    Taichung, 407

  • GSK Investigational Site

    Tainan, 704

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 104

  • GSK Investigational Site

    Taipei, 112

Other trials in Taiwan

Denmark4 sites

  • GSK Investigational Site

    Aarhus, DK-8000

  • GSK Investigational Site

    Esbjerg, 6700

  • GSK Investigational Site

    Koebenhavn OE, 2100

  • GSK Investigational Site

    Silkeborg, 8600

Other trials in Denmark

Mexico4 sites

  • GSK Investigational Site

    Durango, 34080

  • GSK Investigational Site

    México, 10700

  • GSK Investigational Site

    México D.F,, 07760

  • GSK Investigational Site

    Monterrey NL, Nuevo León, 64718

Other trials in Mexico

Norway4 sites

  • GSK Investigational Site

    Bergen, 5021

  • GSK Investigational Site

    Moss, 1501

  • GSK Investigational Site

    Oslo, 0160

  • GSK Investigational Site

    Oslo, 0407

Other trials in Norway

Slovakia4 sites

  • GSK Investigational Site

    Bratislava, 813 69

  • GSK Investigational Site

    Bratislava, 833 05

  • GSK Investigational Site

    Košice, 040 22

  • GSK Investigational Site

    Nitra, 949 01

Other trials in Slovakia

Thailand4 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Bangkok, 10700

  • GSK Investigational Site

    Chiang Mai, 50200

Other trials in Thailand

Estonia3 sites

  • GSK Investigational Site

    Tallinn, 1162

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Peru3 sites

  • GSK Investigational Site

    Callao, Callao 2

  • GSK Investigational Site

    Jesus Maria, Lima region, Lima 11

  • GSK Investigational Site

    Lima, Lima 11

Other trials in Peru

Hong Kong2 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Shatin, New Territories

Other trials in Hong Kong

About this study

Official title: LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.

Read the detailed description

Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.

Conditions
Atherosclerosis
Being tested
Darapladib, Placebo
Keywords
heart disease, Lp-PLA2 inhibitor, cardiovascular disease, coronary heart disease, CV risk, Atherosclerosis
Medical subject headings
Atherosclerosis, Heart Diseases, Cardiovascular Diseases, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DarapladibDrug

    Lp-PLA2 inhibitor administered in addition to standard therapy

  • PlaceboDrug

    Placebo administered in addition to standard therapy

Study groups in NCT00799903
Study groupRoleWhat they receive
DarapladibExperimentalSingle daily oral tablet
Receives: Drug: Darapladib
PlaceboPlacebo comparatorSingle daily oral tablet
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events

    CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

Secondary outcomes (7)

  1. Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events

    CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g.,silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

  2. Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events

    CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort is found not to be caused by myocardial ischemia.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

  3. Number of Participants With CV Death During the Time Period for Follow-up of CV Events

    CV death is defined as a death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

  4. Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events

    Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

  5. Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events

    Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

  6. Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events

    Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

    Measured: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

  7. Number of Participants With All-cause Mortality During the Time Period for Vital Status

    The number of participants with all-cause mortality was assessed.

    Measured: From randomization until death or study completion (up to 4.49 years/average of 3.65 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2008 (estimated)
  2. Study start1 Dec 2008
  3. Primary completion1 Oct 2013
  4. Study completion17 Oct 2013

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15,828 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00799903
Sponsor's protocol ID
100601
Acronym
STABILITY
Status last verified
Mar 2017
First submitted
26 Nov 2008
Last updated
10 Aug 2017
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Jiang W, Huang G, Du J, Yang H, Zhou S, Dai D, Tang K, Fang L, Wang X, Deng X. White blood cell counts can predict 4-year cardiovascular disease risk in patients with stable coronary heart disease: a prospective cohort study. Front Cardiovasc Med. 2024 Sep 26;11:1358378. doi: 10.3389/fcvm.2024.1358378. eCollection 2024.

    PubMed 39390990

  • Sjolin K, Aulin J, Wallentin L, Eriksson N, Held C, Kultima K, Oldgren J, Burman J. Serum Neurofilament Light Chain in Patients With Atrial Fibrillation. J Am Heart Assoc. 2022 Jul 19;11(14):e025910. doi: 10.1161/JAHA.122.025910. Epub 2022 Jul 15.

    PubMed 35861814

  • Held C, Hadziosmanovic N, Aylward PE, Hagstrom E, Hochman JS, Stewart RAH, White HD, Wallentin L. Body Mass Index and Association With Cardiovascular Outcomes in Patients With Stable Coronary Heart Disease - A STABILITY Substudy. J Am Heart Assoc. 2022 Feb;11(3):e023667. doi: 10.1161/JAHA.121.023667. Epub 2022 Jan 21.

    PubMed 35060389

  • Siddiqui MK, Smith G, St Jean P, Dawed AY, Bell S, Soto-Pedre E, Kennedy G, Carr F, Wallentin L, White H, Macphee CH, Waterworth D, Palmer CNA. Diabetes status modifies the long-term effect of lipoprotein-associated phospholipase A2 on major coronary events. Diabetologia. 2022 Jan;65(1):101-112. doi: 10.1007/s00125-021-05574-5. Epub 2021 Sep 25.

    PubMed 34562103

  • Wallentin L, Eriksson N, Olszowka M, Grammer TB, Hagstrom E, Held C, Kleber ME, Koenig W, Marz W, Stewart RAH, White HD, Aberg M, Siegbahn A. Plasma proteins associated with cardiovascular death in patients with chronic coronary heart disease: A retrospective study. PLoS Med. 2021 Jan 13;18(1):e1003513. doi: 10.1371/journal.pmed.1003513. eCollection 2021 Jan.

    PubMed 33439866

  • White HD, Stewart RAH, Dalby AJ, Stebbins A, Cannon CP, Budaj A, Linhart A, Pais P, Diaz R, Steg PG, Krug-Gourley S, Granger CB, Hochman JS, Koenig W, Harrington RA, Held C, Wallentin L; STABILITY Investigators. In patients with stable coronary heart disease, low-density lipoprotein-cholesterol levels < 70 mg/dL and glycosylated hemoglobin A1c < 7% are associated with lower major cardiovascular events. Am Heart J. 2020 Jul;225:97-107. doi: 10.1016/j.ahj.2020.04.004. Epub 2020 Apr 18.

    PubMed 32480059

  • Hilvo M, Wallentin L, Ghukasyan Lakic T, Held C, Kauhanen D, Jylha A, Lindback J, Siegbahn A, Granger CB, Koenig W, Stewart RAH, White H, Laaksonen R; STABILITY Investigators. Prediction of Residual Risk by Ceramide-Phospholipid Score in Patients With Stable Coronary Heart Disease on Optimal Medical Therapy. J Am Heart Assoc. 2020 May 18;9(10):e015258. doi: 10.1161/JAHA.119.015258. Epub 2020 May 7.

    PubMed 32375553

  • Stewart RAH, Held C, Krug-Gourley S, Waterworth D, Stebbins A, Chiswell K, Hagstrom E, Armstrong PW, Wallentin L, White H. Cardiovascular and Lifestyle Risk Factors and Cognitive Function in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2019 Apr 2;8(7):e010641. doi: 10.1161/JAHA.118.010641.

    PubMed 30897999

  • Held C, White HD, Stewart RAH, Budaj A, Cannon CP, Hochman JS, Koenig W, Siegbahn A, Steg PG, Soffer J, Weaver WD, Ostlund O, Wallentin L; STABILITY Investigators. Inflammatory Biomarkers Interleukin-6 and C-Reactive Protein and Outcomes in Stable Coronary Heart Disease: Experiences From the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Oct 24;6(10):e005077. doi: 10.1161/JAHA.116.005077.

    PubMed 29066452

  • Hagstrom E, Norlund F, Stebbins A, Armstrong PW, Chiswell K, Granger CB, Lopez-Sendon J, Pella D, Soffer J, Sy R, Wallentin L, White HD, Stewart RAH, Held C. Psychosocial stress and major cardiovascular events in patients with stable coronary heart disease. J Intern Med. 2018 Jan;283(1):83-92. doi: 10.1111/joim.12692. Epub 2017 Oct 23.

    PubMed 28960596

  • Guimaraes PO, Granger CB, Stebbins A, Chiswell K, Held C, Hochman JS, Krug-Gourley S, Lonn E, Lopes RD, Stewart RAH, Vinereanu D, Wallentin L, White HD, Hagstrom E, Danchin N. Sex Differences in Clinical Characteristics, Psychosocial Factors, and Outcomes Among Patients With Stable Coronary Heart Disease: Insights from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Sep 14;6(9):e006695. doi: 10.1161/JAHA.117.006695.

    PubMed 28912210

  • Stewart RAH, Hagstrom E, Held C, Wang TKM, Armstrong PW, Aylward PE, Cannon CP, Koenig W, Lopez-Sendon JL, Mohler ER 3rd, Hadziosmanovic N, Krug-Gourley S, Ramos Corrales MA, Siddique S, Steg PG, White HD, Wallentin L; STABILITY Investigators. Self-Reported Health and Outcomes in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2017 Aug 22;6(8):e006096. doi: 10.1161/JAHA.117.006096.

    PubMed 28862971

  • Lindholm D, Lindback J, Armstrong PW, Budaj A, Cannon CP, Granger CB, Hagstrom E, Held C, Koenig W, Ostlund O, Stewart RAH, Soffer J, White HD, de Winter RJ, Steg PG, Siegbahn A, Kleber ME, Dressel A, Grammer TB, Marz W, Wallentin L. Biomarker-Based Risk Model to Predict Cardiovascular Mortality in Patients With Stable Coronary Disease. J Am Coll Cardiol. 2017 Aug 15;70(7):813-826. doi: 10.1016/j.jacc.2017.06.030.

    PubMed 28797349

  • Vedin O, Hagstrom E, Ostlund O, Avezum A, Budaj A, Flather MD, Harrington RA, Koenig W, Soffer J, Siegbahn A, Steg PG, Stewart RAH, Wallentin L, White HD, Held C; STABILITY Investigators. Associations between tooth loss and prognostic biomarkers and the risk for cardiovascular events in patients with stable coronary heart disease. Int J Cardiol. 2017 Oct 15;245:271-276. doi: 10.1016/j.ijcard.2017.07.036. Epub 2017 Jul 17.

    PubMed 28735759

  • Hagstrom E, Held C, Stewart RA, Aylward PE, Budaj A, Cannon CP, Koenig W, Krug-Gourley S, Mohler ER 3rd, Steg PG, Tarka E, Ostlund O, White HD, Siegbahn A, Wallentin L; STABILITY Investigators. Growth Differentiation Factor 15 Predicts All-Cause Morbidity and Mortality in Stable Coronary Heart Disease. Clin Chem. 2017 Jan;63(1):325-333. doi: 10.1373/clinchem.2016.260570. Epub 2016 Nov 3.

    PubMed 27811204

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darapladib in people with Atherosclerosis, run by GlaxoSmithKline at 650 sites in 39 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 10 inclusion and 13 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 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 650 sites in United States, Germany, Canada, France, Russia and 34 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events (time frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)). 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 NCT00799903, which also lists 21 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 10 Aug 2017.

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