A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60) (LATITUDE)

April 27, 2017 updated by: GlaxoSmithKline

A Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (PM1116197) LosmApimod To Inhibit p38 MAP Kinase as a TherapeUtic Target and moDify Outcomes After an Acute Coronary syndromE (LATITUDE)-TIMI 60.

Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3503

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1428DCO
        • GSK Investigational Site
      • Corrientes, Argentina, W3400AMZ
        • GSK Investigational Site
      • Santa Fe, Argentina, S3000AZG
        • GSK Investigational Site
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, B1878DFK
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSR
        • GSK Investigational Site
      • Venado Tuerto, Santa Fe, Argentina, 2600
        • GSK Investigational Site
  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • GSK Investigational Site
      • Cairns, Queensland, Australia, 4870
        • GSK Investigational Site
      • Herston, Queensland, Australia, 4029
        • GSK Investigational Site
      • Nambour, Queensland, Australia, 4560
        • GSK Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • GSK Investigational Site
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • GSK Investigational Site
    • Victoria
      • Epping, Victoria, Australia, 3076
        • GSK Investigational Site
      • Geelong, Victoria, Australia, 3220
        • GSK Investigational Site
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • GSK Investigational Site
      • Nedlands, Western Australia, Australia, 6009
        • GSK Investigational Site
  • Belgium
      • Aalst, Belgium, 9300
        • GSK Investigational Site
      • Bonheiden, Belgium, 2820
        • GSK Investigational Site
      • Brasschaat, Belgium, 2930
        • GSK Investigational Site
      • Brugge, Belgium, 8000
        • GSK Investigational Site
      • Genk, Belgium, 3600
        • GSK Investigational Site
      • Gent, Belgium, 9000
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
      • Liège, Belgium, 4000
        • GSK Investigational Site
      • Mechelen, Belgium, 2800
        • GSK Investigational Site
      • Yvoir, Belgium, 5530
        • GSK Investigational Site
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • GSK Investigational Site
      • Dimitrovgrad, Bulgaria, 6400
        • GSK Investigational Site
      • Pazardjik, Bulgaria, 4400
        • GSK Investigational Site
      • Sofia, Bulgaria, 1407
        • GSK Investigational Site
      • Sofia, Bulgaria, 1000
        • GSK Investigational Site
      • Sofia, Bulgaria, 1572
        • GSK Investigational Site
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • GSK Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • GSK Investigational Site
      • Victoria, British Columbia, Canada, V8R 4R2
        • GSK Investigational Site
    • Ontario
      • Kitchener, Ontario, Canada, N2M 1B2
        • GSK Investigational Site
      • Scarborough, Ontario, Canada, M1E 5E9
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3E5J1
        • GSK Investigational Site
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • GSK Investigational Site
  • Chile
      • Santiago, Chile, 8207257
        • GSK Investigational Site
    • Región De La Araucania
      • Temuco, Región De La Araucania, Chile
        • GSK Investigational Site
    • Región Del Biobio
      • Concepción, Región Del Biobio, Chile, 4070038
        • GSK Investigational Site
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 8330024
        • GSK Investigational Site
  • Czechia
      • Brno, Czechia, 625 00
        • GSK Investigational Site
      • Ceske Budejovice, Czechia, 370 01
        • GSK Investigational Site
      • Hradec Kralove, Czechia, 500 05
        • GSK Investigational Site
      • Liberec, Czechia, 460 63
        • GSK Investigational Site
      • Ostrava., Czechia, 708 52
        • GSK Investigational Site
      • Pardubice, Czechia, 523 03
        • GSK Investigational Site
      • Praha 10, Czechia, 101 00
        • GSK Investigational Site
      • Praha 2, Czechia, 128 08
        • GSK Investigational Site
      • Praha 6, Czechia, 169 02
        • GSK Investigational Site
      • Usti nad Labem, Czechia, 401 13
        • GSK Investigational Site
      • Zlin, Czechia, 762 75
        • GSK Investigational Site
  • Denmark
      • Hellerup, Denmark, DK-2900
        • GSK Investigational Site
      • Hvidovre, Denmark, 2650
        • GSK Investigational Site
      • København NV, Denmark, DK-2400
        • GSK Investigational Site
      • København S, Denmark, DK-2300
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 13419
        • GSK Investigational Site
      • Tallinn, Estonia, 10138
        • GSK Investigational Site
      • Tartu, Estonia, 51014
        • GSK Investigational Site
  • France
      • Besançon Cedex, France, 25030
        • GSK Investigational Site
      • Dijon, France, 21079
        • GSK Investigational Site
      • Montauban cedex, France, 82017
        • GSK Investigational Site
      • Nantes cedex 1, France, 44093
        • GSK Investigational Site
      • Paris Cedex 18, France, 75877
        • GSK Investigational Site
      • Pau, France, 64000
        • GSK Investigational Site
      • Strasbourg cedex, France, 67091
        • GSK Investigational Site
      • Toulouse cedex 09, France, 31059
        • GSK Investigational Site
      • Tourcoing cedex, France, 59208
        • GSK Investigational Site
      • Valenciennes Cedex, France, 59322
        • GSK Investigational Site
  • Germany
      • Hamburg, Germany, 20246
        • GSK Investigational Site
      • Hamburg, Germany, 22291
        • GSK Investigational Site
      • Hamburg, Germany, 20099
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Bad Krozingen, Baden-Wuerttemberg, Germany, 79189
        • GSK Investigational Site
      • Esslingen, Baden-Wuerttemberg, Germany, 73730
        • GSK Investigational Site
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Germany, 70376
        • GSK Investigational Site
    • Brandenburg
      • Bernau, Brandenburg, Germany, 16321
        • GSK Investigational Site
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
        • GSK Investigational Site
      • Frankfurt, Hessen, Germany, 65929
        • GSK Investigational Site
      • Giessen, Hessen, Germany, 35392
        • GSK Investigational Site
      • Kassel, Hessen, Germany, 34121
        • GSK Investigational Site
      • Langen, Hessen, Germany, 63225
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
        • GSK Investigational Site
      • Bielefeld, Nordrhein-Westfalen, Germany, 33604
        • GSK Investigational Site
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • GSK Investigational Site
      • Dortmund, Nordrhein-Westfalen, Germany, 44137
        • GSK Investigational Site
      • Leverkusen, Nordrhein-Westfalen, Germany, 51375
        • GSK Investigational Site
      • Moenchengladbach, Nordrhein-Westfalen, Germany, 41063
        • GSK Investigational Site
      • Wuppertal, Nordrhein-Westfalen, Germany, 42117
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04289
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04103
        • GSK Investigational Site
  • Greece
      • Alexandroupolis, Greece, 68100
        • GSK Investigational Site
      • Athens, Greece, 115 28
        • GSK Investigational Site
      • Athens, Greece, 115 26
        • GSK Investigational Site
      • Chalkida, Greece, 341 00
        • GSK Investigational Site
      • N. Efkarpia, Thessaloniki, Greece, 56429
        • GSK Investigational Site
      • Thessaloniki, Greece, 570 10
        • GSK Investigational Site
  • Hong Kong
      • Chai Wan, Hong Kong
        • GSK Investigational Site
      • Kowloon, Hong Kong
        • GSK Investigational Site
      • Shatin, New Territories, Hong Kong
        • GSK Investigational Site
  • Hungary
      • Balatonfüred, Hungary, 8230
        • GSK Investigational Site
      • Budapest, Hungary, 1122
        • GSK Investigational Site
      • Budapest, Hungary, 1134
        • GSK Investigational Site
      • Szolnok, Hungary, 5004
        • GSK Investigational Site
      • Zalaegerszeg, Hungary, 8900
        • GSK Investigational Site
  • Israel
      • Ashkelon, Israel, 78278
        • GSK Investigational Site
      • Haddera, Israel, 38100
        • GSK Investigational Site
      • Kfar Saba, Israel, 44281
        • GSK Investigational Site
      • Nahariya, Israel, 22100
        • GSK Investigational Site
      • Tel Aviv, Israel, 64239
        • GSK Investigational Site
  • Italy
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italy, 43100
        • GSK Investigational Site
    • Friuli-Venezia-Giulia
      • Udine, Friuli-Venezia-Giulia, Italy, 33100
        • GSK Investigational Site
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • GSK Investigational Site
      • Cremona, Lombardia, Italy, 26100
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20162
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20138
        • GSK Investigational Site
    • Umbria
      • Perugia, Umbria, Italy, 06156
        • GSK Investigational Site
  • Korea, Republic of
      • Daejeon, Korea, Republic of, 301-721
        • GSK Investigational Site
      • Ganwon-do, Korea, Republic of, 220-701
        • GSK Investigational Site
      • Gwangju, Korea, Republic of, 501-757
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 135-720
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 152-703
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 134-727
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 110-774
        • GSK Investigational Site
  • Mexico
      • Queretaro, Mexico, 76000
        • GSK Investigational Site
      • San Luis Potosi, Mexico, 78240
        • GSK Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • GSK Investigational Site
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • GSK Investigational Site
      • Amersfoort, Netherlands, 3813 TZ
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1091 AC
        • GSK Investigational Site
      • Delft, Netherlands, 2625 AD
        • GSK Investigational Site
      • Deventer, Netherlands, 7416 SE
        • GSK Investigational Site
      • Helmond, Netherlands, 5707 HA
        • GSK Investigational Site
      • Nieuwegein, Netherlands, 3435 CM
        • GSK Investigational Site
      • Nijmegen, Netherlands, 6532 SZ
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3045 PM
        • GSK Investigational Site
      • Schiedam, Netherlands, 3118 JH
        • GSK Investigational Site
      • Sittard-geleen, Netherlands, 6162 BG
        • GSK Investigational Site
      • Tilburg, Netherlands, 5042 AD
        • GSK Investigational Site
      • Venlo, Netherlands, 5912 BL
        • GSK Investigational Site
      • Zwolle, Netherlands, 8025 AB
        • GSK Investigational Site
  • New Zealand
      • Christchurch, New Zealand, 8011
        • GSK Investigational Site
      • Grafton, Auckland, New Zealand, 1030
        • GSK Investigational Site
      • Hamilton, New Zealand, 3204
        • GSK Investigational Site
      • New Plymouth, New Zealand, 4310
        • GSK Investigational Site
      • Otahuhu, Auckland, New Zealand, 1640
        • GSK Investigational Site
      • Wellington South, New Zealand, 6021
        • GSK Investigational Site
  • Norway
      • Lillehammer, Norway, 2629
        • GSK Investigational Site
      • Oslo, Norway, 0407
        • GSK Investigational Site
      • Skien, Norway, N-3710
        • GSK Investigational Site
      • Stavanger, Norway, 4011
        • GSK Investigational Site
      • Tromsø, Norway, 9038
        • GSK Investigational Site
  • Philippines
      • Manila, Philippines, 1000
        • GSK Investigational Site
      • Pasig City, Philippines, 1600
        • GSK Investigational Site
      • Quezon City, Philippines, 1100
        • GSK Investigational Site
      • San Juan, Philippines, 1500
        • GSK Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-094
        • GSK Investigational Site
      • Gdansk, Poland, 80-952
        • GSK Investigational Site
      • Gdynia, Poland, 81-348
        • GSK Investigational Site
      • Inowroclaw, Poland, 88-100
        • GSK Investigational Site
      • Krakow, Poland, 31-202
        • GSK Investigational Site
      • Lubin, Poland, 59-301
        • GSK Investigational Site
      • Lublin, Poland, 20-954
        • GSK Investigational Site
      • Olsztyn, Poland, 10-561
        • GSK Investigational Site
      • Torun, Poland, 87-100
        • GSK Investigational Site
      • Walbrzych, Poland, 58-309
        • GSK Investigational Site
      • Warszawa, Poland, 04-073
        • GSK Investigational Site
      • Wroclaw, Poland, 50-556
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 050098
        • GSK Investigational Site
      • Bucharest, Romania, 014461
        • GSK Investigational Site
      • Craiova, Romania, 200642
        • GSK Investigational Site
  • Russian Federation
      • Barnaul, Russian Federation, 656055
        • GSK Investigational Site
      • Gatchina, Russian Federation, 188300
        • GSK Investigational Site
      • Irkutsk, Russian Federation, 664049
        • GSK Investigational Site
      • Kemerovo, Russian Federation, 650002
        • GSK Investigational Site
      • Moscow, Russian Federation, 117292
        • GSK Investigational Site
      • Moscow, Russian Federation, 111539
        • GSK Investigational Site
      • Moscow, Russian Federation, 121552
        • GSK Investigational Site
      • Moscow, Russian Federation, 121374
        • GSK Investigational Site
      • Novosibirsk, Russian Federation, 630008
        • GSK Investigational Site
      • Perm, Russian Federation, 614107
        • GSK Investigational Site
      • Ryazan, Russian Federation, 390026
        • GSK Investigational Site
      • Ryazan, Russian Federation, 390039
        • GSK Investigational Site
      • Samara, Russian Federation, 443070
        • GSK Investigational Site
      • Saratov, Russian Federation, 410028
        • GSK Investigational Site
      • Saratov, Russian Federation, 410012
        • GSK Investigational Site
      • St-Petersburg, Russian Federation, 199106
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 190000
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 192242
        • GSK Investigational Site
      • Tomsk, Russian Federation, 634012
        • GSK Investigational Site
      • Tyumen, Russian Federation, 625023
        • GSK Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 833 48
        • GSK Investigational Site
      • Kosice, Slovakia, 040 11
        • GSK Investigational Site
      • Martin, Slovakia, 036 59
        • GSK Investigational Site
      • Nitra, Slovakia, 949 01
        • GSK Investigational Site
  • South Africa
      • Bellville, South Africa, 7530
        • GSK Investigational Site
      • Cape Town, South Africa, 7505
        • GSK Investigational Site
      • Kuils River, South Africa, 7580
        • GSK Investigational Site
      • Parktown West, South Africa, 2193
        • GSK Investigational Site
      • Pinelands, South Africa, 7405
        • GSK Investigational Site
      • Somerset West, South Africa, 7130
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Barcelona, Spain, 08907
        • GSK Investigational Site
      • Galdakano, Spain, 48960
        • GSK Investigational Site
      • Madrid, Spain, 28007
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Majadahonda (Madrid), Spain, 28222
        • GSK Investigational Site
      • Malaga, Spain, 29010
        • GSK Investigational Site
      • Marid, Spain, 28040
        • GSK Investigational Site
      • Santiago De Compostela, Spain, 15706
        • GSK Investigational Site
      • Sevilla, Spain, 41071
        • GSK Investigational Site
  • Sweden
      • Göteborg, Sweden, SE-413 45
        • GSK Investigational Site
      • Göteborg, Sweden, SE-416 85
        • GSK Investigational Site
      • Helsingborg, Sweden, SE-251 87
        • GSK Investigational Site
      • Jönköping, Sweden, SE-551 85
        • GSK Investigational Site
      • Stockholm, Sweden, SE-118 83
        • GSK Investigational Site
      • Västerås, Sweden, SE-721 89
        • GSK Investigational Site
      • Örebro, Sweden, SE-701 85
        • GSK Investigational Site
      • Östersund, Sweden, SE-831 83
        • GSK Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • GSK Investigational Site
      • Hualien, Taiwan, 970
        • GSK Investigational Site
      • Kaohsiung, Taiwan, 813
        • GSK Investigational Site
      • Taipei, Taiwan, 112
        • GSK Investigational Site
      • Taipei City, Taiwan, 104
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • GSK Investigational Site
      • Bangkok, Thailand, 10330
        • GSK Investigational Site
      • Bangkok, Thailand, 10700
        • GSK Investigational Site
      • Chiangmai, Thailand, 50200
        • GSK Investigational Site
  • Ukraine
      • Cherkassy, Ukraine, 18009
        • GSK Investigational Site
      • Ivano-Frankivsk, Ukraine, 76018
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61018
        • GSK Investigational Site
      • Kyiv, Ukraine, 03680
        • GSK Investigational Site
      • Lviv, Ukraine, 79015
        • GSK Investigational Site
      • Uzhhorod, Ukraine, 88014
        • GSK Investigational Site
      • Zaporizhzhya, Ukraine, 69000
        • GSK Investigational Site
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • GSK Investigational Site
      • Bournemouth, United Kingdom, BH7 7DW
        • GSK Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • GSK Investigational Site
      • Edinburgh, United Kingdom, EH16 4SA
        • GSK Investigational Site
      • Newcastle-upon-Tyne, United Kingdom, NE7 7DN
        • GSK Investigational Site
      • York, United Kingdom, YO31 8HE
        • GSK Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • GSK Investigational Site
    • Arizona
      • Cottonwood, Arizona, United States, 86326
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85724
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85713
        • GSK Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • GSK Investigational Site
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Bakersfield, California, United States, 93308
        • GSK Investigational Site
      • Huntington Beach, California, United States, 92648
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Mission Viejo, California, United States, 92691
        • GSK Investigational Site
      • Monterey, California, United States, 93940
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • San Diego, California, United States, 92161
        • GSK Investigational Site
      • Torrance, California, United States, 90509
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80204
        • GSK Investigational Site
      • Littleton, Colorado, United States, 80120
        • GSK Investigational Site
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32209
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32207
        • GSK Investigational Site
      • Jacksonville Beach, Florida, United States, 32250
        • GSK Investigational Site
      • Ocala, Florida, United States, 34471
        • GSK Investigational Site
      • Pensacola, Florida, United States, 32501
        • GSK Investigational Site
      • Tallahassee, Florida, United States, 32308
        • GSK Investigational Site
      • Tampa, Florida, United States, 33613
        • GSK Investigational Site
      • Vero Beach, Florida, United States, 32960
        • GSK Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30901
        • GSK Investigational Site
      • Rome, Georgia, United States, 30165
        • GSK Investigational Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • GSK Investigational Site
    • Illinois
      • Aurora, Illinois, United States, 60504
        • GSK Investigational Site
      • Elmhurst, Illinois, United States, 60126
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • GSK Investigational Site
      • Muncie, Indiana, United States, 47303
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52240
        • GSK Investigational Site
      • West Des Moines, Iowa, United States, 50266
        • GSK Investigational Site
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • GSK Investigational Site
      • Baton Rouge, Louisiana, United States, 70809
        • GSK Investigational Site
      • Slidell, Louisiana, United States, 70458
        • GSK Investigational Site
      • Zachary, Louisiana, United States, 70791
        • GSK Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • GSK Investigational Site
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • GSK Investigational Site
      • Grand Blanc, Michigan, United States, 48439
        • GSK Investigational Site
      • Marquette, Michigan, United States, 49855
        • GSK Investigational Site
      • Rochester, Michigan, United States, 48307
        • GSK Investigational Site
      • Troy, Michigan, United States, 48085
        • GSK Investigational Site
      • Ypsilanti, Michigan, United States, 48197
        • GSK Investigational Site
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • GSK Investigational Site
      • Minneapolis, Minnesota, United States, 55407
        • GSK Investigational Site
      • Saint Paul, Minnesota, United States, 55101
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • GSK Investigational Site
      • Saint Louis, Missouri, United States, 63110
        • GSK Investigational Site
      • Springfield, Missouri, United States, 65804
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68124
        • GSK Investigational Site
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • GSK Investigational Site
      • Ridgewood, New Jersey, United States, 07450
        • GSK Investigational Site
      • Teaneck, New Jersey, United States, 07666
        • GSK Investigational Site
      • Voorhees, New Jersey, United States, 08043
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • GSK Investigational Site
      • Poughkeepsie, New York, United States, 12601
        • GSK Investigational Site
      • Stony Brook, New York, United States, 11794
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • GSK Investigational Site
      • Greensboro, North Carolina, United States, 27401
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27610
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44710
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44106
        • GSK Investigational Site
      • Columbus, Ohio, United States, 45215
        • GSK Investigational Site
      • Mansfield, Ohio, United States, 44906
        • GSK Investigational Site
      • Zanesville, Ohio, United States, 43701
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • GSK Investigational Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • GSK Investigational Site
      • Chambersburg, Pennsylvania, United States, 17201
        • GSK Investigational Site
      • Danville, Pennsylvania, United States, 17822-2160
        • GSK Investigational Site
      • Doylestown, Pennsylvania, United States, 18901
        • GSK Investigational Site
      • Wilkes-Barre, Pennsylvania, United States, 18702
        • GSK Investigational Site
      • York, Pennsylvania, United States, 17403
        • GSK Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • GSK Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • GSK Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404-1173
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37205
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • GSK Investigational Site
      • Dallas, Texas, United States, 75216
        • GSK Investigational Site
      • Round Rock, Texas, United States, 78681
        • GSK Investigational Site
      • Victoria, Texas, United States, 77901
        • GSK Investigational Site
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • GSK Investigational Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • GSK Investigational Site
    • Wisconsin
      • Manitowoc, Wisconsin, United States, 54220
        • GSK Investigational Site
      • Wausau, Wisconsin, United States, 54401
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written informed consent
  • Men or women at least 35 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy
  • Hospitalization for NSTEMI or STEMI (Universal Definition Type 1 MI)
  • With the following timing of symptoms: NSTEMI: Presence of ischemic symptoms (>=5 minutes) at rest within 24 hours prior to randomization (may include qualifying episode). STEMI: Onset of qualifying ischemic symptoms within 12 hours of randomization.
  • At least one of the following
  • Age >=60 years at randomization.
  • Myocardial infarction prior to the qualifying ACS event
  • CABG prior to qualifying ACS event.
  • NSTEMI with new ischemic ST-segment depression >= 0.1 mV in >= 2 contiguous leads.
  • Diabetes mellitus requiring pharmacotherapy.
  • Coexistent clinically diagnosed arterial disease

Exclusion Criteria:

  • Unable to be randomized prior to coronary revascularization or fibrinolysis for the qualifying MI.
  • Current severe heart failure or shock
  • Ongoing clinical instability
  • History of chronic liver disease
  • Known severe renal impairment
  • Any condition, other than vascular disease, with life expectancy <1 year that might prevent the subject from completing the study.
  • Known active tuberculosis, HIV, active opportunistic or life threatening infections.
  • Vaccination with a live attenuated vaccine within 6 weeks of randomization.
  • Concomitant use of cytotoxic chemotherapy for cancer or known ongoing or anticipated use of chronic severe immunosuppressive agents
  • Positive pregnancy test or is known to be pregnant or lactating
  • Known alcohol or drug abuse within the past 6 months
  • Any current mental condition, which may affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study.
  • Participation in a study of an investigational medication within the past 30 days.
  • Anticipated inability to comply with any study procedures, including participation in study visits according to the visit schedule through 24 weeks.
  • Use of another investigational product within 30 days or 5 half-lives (whichever is longer) or according to local regulations, or currently participating in a study of an investigational device. Subjects must be randomized only one time in this investigational study
  • Any other reason the investigator deems the subject to be unsuitable for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Losmapimod
Losmapimod 7.5 mg twice daily oral tablet
Drug: Losmapimod 7.5 mg twice daily
Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets.
Other Names:
  • GW856553
Drug: Standard therapy
Subjects will receive standard therapy consistent with the appropriate guidelines from professional societies. The standard therapy includes nitrates, morphine sulfate, beta adrenergic blockers, renin-angiotensin aldosterone inhibitors, other anti-ischemic therapies, and analgesic therapy.
PLACEBO_COMPARATOR: Placebo
Placebo twice daily oral tablet
Drug: Standard therapy
Subjects will receive standard therapy consistent with the appropriate guidelines from professional societies. The standard therapy includes nitrates, morphine sulfate, beta adrenergic blockers, renin-angiotensin aldosterone inhibitors, other anti-ischemic therapies, and analgesic therapy.
Drug: Placebo twice daily
Subjects will receive placebo as film-coated, round, plain faced tablets.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12
Time Frame: Up to 12 weeks
The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death (death due to a cardiovascular cause), MI or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization). Death for which the Clinical Events Committee (CEC) or investigator were unable to establish cause were analyzed as CV deaths.
Up to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With First Occurrence of MACE Through Week 24
Time Frame: Up to Week 24
Number of participants with first occurrence of MACE through Week 24 including CV death, MI or SRI-UR are presented. Death for which the CEC or investigator were unable to establish cause were analyzed as CV deaths.
Up to Week 24
Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24
Time Frame: Week 12 and Week 24
Week 12 results are considered the principal secondary endpoint. Number of participants with first occurrence of the composite of CV death or MI up to Week 12 and Week 24 are summarized.
Week 12 and Week 24
Number of Participants With First Occurrence of the Composite of CV Death, MI or Hospitalization for Heart Failure (HF) up to Week 12 and Week 24.
Time Frame: Week 12 and Week 24
Number of participants with first occurrence of the composite of CV death, MI or hospitalization for HF up to Week 12 and Week 24 are presented.
Week 12 and Week 24
Number of Participants With First Occurrence of the Expanded Composite of Arterial CV Events Defined as CV Death, MI, SRI-UR or Stroke Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of the expanded composite of arterial CV events defined as CV death, MI, SRI-UR or stroke through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of the Composite of Coronary Events Defined as CHD Death, MI, SRI-UR or Any Unplanned Coronary Artery Revascularization Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of the composite of coronary events defined as coronary heart disease (CHD) death, MI, SRI-UR or any unplanned coronary artery revascularization through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of the composite of CV death or hospitalization for HF through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of the composite of CV death, MI or stroke through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of the Expanded Composite of CV Death, MI, SRI-UR, Stroke or Hospitalization for HF Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of the expanded composite of CV death, MI, SRI-UR, stroke or hospitalization for HF through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of the composite of CHD death, MI or SRI-UR through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of the composite of CHD death or MI through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of the composite of all-cause death, MI or SRI-UR through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of the composite of all-cause death or MI through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of the Composite of CV Death, Type I (Spontaneous) MI or SRI-UR Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of the composite of CV death, type I (spontaneous) MI or SRI-UR through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of the composite of CV death or type I (spontaneous) MI through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of definite or probable stent thrombosis through to Week 12 and Week 24 are presented. Participants receiving stent prior to randomization or during the study prior to Week 12 were included.
Week 12, Week 24
Number of Participants Re-hospitalized Within 30 Days of Discharge
Time Frame: Within up to 30 days of post discharge
Participants who had a death or re-hospitalization within 30 days of discharge, plus participants who were never discharged from the initial hospitalization were included.
Within up to 30 days of post discharge
Number of Participants With All-cause Mortality Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with all-cause mortality through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With CV Death Events Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with CV death events through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With CHD Death Events Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with CHD death events through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of Myocardial Infarction (Fatal and Non-fatal) Events Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of myocardial infarction (fatal and non-fatal) events through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of Type I (Spontaneous) MI Events Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of type I (spontaneous) MI events through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of SRI-UR Events Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of SRI-UR events through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of Stroke (Fatal and Non-fatal) Events Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of stroke (fatal and non-fatal) events through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of Hospitalization for HF Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of hospitalization for HF through to Week 12 and Week 24 are presented.
Week 12, Week 24
Number of Participants With First Occurrence of Any Unplanned Coronary Revascularization Through to Week 12 and Week 24
Time Frame: Week 12, Week 24
Number of participants with first occurrence of any unplanned coronary revascularization through to Week 12 and Week 24 are presented.
Week 12, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The TIMI Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 116197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: 116197
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: 116197
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: 116197
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: 116197
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 116197
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: 116197
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: 116197
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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