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

Study Type

Interventional

Enrollment (Actual)

3503

Phase

  • 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

      • 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
    • 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
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      • Aalst, Belgium, 9300
        • GSK Investigational Site
      • Bonheiden, Belgium, 2820
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      • Brasschaat, Belgium, 2930
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      • Brugge, Belgium, 8000
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      • Genk, Belgium, 3600
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      • Gent, Belgium, 9000
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      • Leuven, Belgium, 3000
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      • Liège, Belgium, 4000
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      • Mechelen, Belgium, 2800
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      • Yvoir, Belgium, 5530
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      • Blagoevgrad, Bulgaria, 2700
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      • Dimitrovgrad, Bulgaria, 6400
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      • Pazardjik, Bulgaria, 4400
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      • Sofia, Bulgaria, 1407
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      • Sofia, Bulgaria, 1000
        • GSK Investigational Site
      • Sofia, Bulgaria, 1572
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    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
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      • Vancouver, British Columbia, Canada, V5Z 1M9
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      • Victoria, British Columbia, Canada, V8R 4R2
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    • Ontario
      • Kitchener, Ontario, Canada, N2M 1B2
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      • Scarborough, Ontario, Canada, M1E 5E9
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      • Sudbury, Ontario, Canada, P3E5J1
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      • Thunder Bay, Ontario, Canada, P7B 6V4
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    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
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      • Sherbrooke, Quebec, Canada, J1H 5N4
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      • Santiago, Chile, 8207257
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    • Región De La Araucania
      • Temuco, Región De La Araucania, Chile
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    • Región Del Biobio
      • Concepción, Región Del Biobio, Chile, 4070038
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    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 8330024
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      • Zlin, Czechia, 762 75
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      • Hvidovre, Denmark, 2650
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      • København NV, Denmark, DK-2400
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      • København S, Denmark, DK-2300
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      • Mannheim, Baden-Wuerttemberg, Germany, 68167
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      • Bernau, Brandenburg, Germany, 16321
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      • Chalkida, Greece, 341 00
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      • N. Efkarpia, Thessaloniki, Greece, 56429
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      • Balatonfüred, Hungary, 8230
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      • Budapest, Hungary, 1134
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      • Szolnok, Hungary, 5004
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      • Zalaegerszeg, Hungary, 8900
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      • Kfar Saba, Israel, 44281
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      • Nahariya, Israel, 22100
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      • Tel Aviv, Israel, 64239
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    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italy, 43100
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      • Udine, Friuli-Venezia-Giulia, Italy, 33100
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    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
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      • Cremona, Lombardia, Italy, 26100
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      • Milano, Lombardia, Italy, 20162
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      • Milano, Lombardia, Italy, 20138
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    • Umbria
      • Perugia, Umbria, Italy, 06156
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      • Daejeon, Korea, Republic of, 301-721
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      • Ganwon-do, Korea, Republic of, 220-701
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      • Gwangju, Korea, Republic of, 501-757
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      • Seoul, Korea, Republic of, 137-701
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      • Seoul, Korea, Republic of, 135-720
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      • Seoul, Korea, Republic of, 152-703
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      • Seoul, Korea, Republic of, 134-727
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      • Seoul, Korea, Republic of, 110-774
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      • Queretaro, Mexico, 76000
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      • San Luis Potosi, Mexico, 78240
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    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
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      • Alkmaar, Netherlands, 1815 JD
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      • Amersfoort, Netherlands, 3813 TZ
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      • Amsterdam, Netherlands, 1091 AC
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      • Delft, Netherlands, 2625 AD
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      • Deventer, Netherlands, 7416 SE
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      • Helmond, Netherlands, 5707 HA
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      • Nieuwegein, Netherlands, 3435 CM
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      • Nijmegen, Netherlands, 6532 SZ
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      • Rotterdam, Netherlands, 3045 PM
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      • Schiedam, Netherlands, 3118 JH
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      • Sittard-geleen, Netherlands, 6162 BG
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      • Tilburg, Netherlands, 5042 AD
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      • Venlo, Netherlands, 5912 BL
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      • Zwolle, Netherlands, 8025 AB
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      • Christchurch, New Zealand, 8011
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      • Grafton, Auckland, New Zealand, 1030
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      • Hamilton, New Zealand, 3204
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      • New Plymouth, New Zealand, 4310
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      • Otahuhu, Auckland, New Zealand, 1640
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      • Wellington South, New Zealand, 6021
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      • Lillehammer, Norway, 2629
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      • Oslo, Norway, 0407
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      • Skien, Norway, N-3710
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      • Stavanger, Norway, 4011
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      • Tromsø, Norway, 9038
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      • Manila, Philippines, 1000
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      • Pasig City, Philippines, 1600
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      • Quezon City, Philippines, 1100
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      • San Juan, Philippines, 1500
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      • Bydgoszcz, Poland, 85-094
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      • Gdansk, Poland, 80-952
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      • Gdynia, Poland, 81-348
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      • Inowroclaw, Poland, 88-100
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      • Krakow, Poland, 31-202
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      • Lubin, Poland, 59-301
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      • Lublin, Poland, 20-954
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      • Olsztyn, Poland, 10-561
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      • Torun, Poland, 87-100
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      • Walbrzych, Poland, 58-309
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      • Warszawa, Poland, 04-073
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      • Wroclaw, Poland, 50-556
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      • Bucharest, Romania, 050098
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      • Bucharest, Romania, 014461
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      • Craiova, Romania, 200642
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      • Barnaul, Russian Federation, 656055
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      • Gatchina, Russian Federation, 188300
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      • Irkutsk, Russian Federation, 664049
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      • Kemerovo, Russian Federation, 650002
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      • Moscow, Russian Federation, 117292
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      • Moscow, Russian Federation, 111539
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      • Moscow, Russian Federation, 121552
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      • Moscow, Russian Federation, 121374
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      • Novosibirsk, Russian Federation, 630008
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      • Perm, Russian Federation, 614107
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      • Ryazan, Russian Federation, 390026
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      • Ryazan, Russian Federation, 390039
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      • Samara, Russian Federation, 443070
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      • Saratov, Russian Federation, 410028
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      • Saratov, Russian Federation, 410012
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      • St-Petersburg, Russian Federation, 199106
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      • St. Petersburg, Russian Federation, 190000
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      • St. Petersburg, Russian Federation, 192242
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      • Tomsk, Russian Federation, 634012
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      • Tyumen, Russian Federation, 625023
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      • Bratislava, Slovakia, 833 48
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      • Kosice, Slovakia, 040 11
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      • Martin, Slovakia, 036 59
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      • Nitra, Slovakia, 949 01
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      • Bellville, South Africa, 7530
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      • Barcelona, Spain, 08036
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      • Barcelona, Spain, 08035
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      • Barcelona, Spain, 08907
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      • Galdakano, Spain, 48960
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      • Madrid, Spain, 28007
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      • Madrid, Spain, 28046
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      • Madrid, Spain, 28034
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      • Majadahonda (Madrid), Spain, 28222
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      • Malaga, Spain, 29010
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      • Marid, Spain, 28040
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      • Santiago De Compostela, Spain, 15706
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      • Sevilla, Spain, 41071
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      • Göteborg, Sweden, SE-413 45
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      • Göteborg, Sweden, SE-416 85
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      • Helsingborg, Sweden, SE-251 87
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      • Jönköping, Sweden, SE-551 85
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      • Stockholm, Sweden, SE-118 83
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      • Västerås, Sweden, SE-721 89
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      • Örebro, Sweden, SE-701 85
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      • Östersund, Sweden, SE-831 83
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      • Changhua, Taiwan, 500
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      • Hualien, Taiwan, 970
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      • Taipei, Taiwan, 112
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      • Taipei City, Taiwan, 104
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      • Bangkok, Thailand, 10400
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      • Bangkok, Thailand, 10330
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      • Kyiv, Ukraine, 03680
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      • Zaporizhzhya, Ukraine, 69000
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      • Basingstoke, United Kingdom, RG24 9NA
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      • Edinburgh, United Kingdom, EH16 4SA
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      • York, United Kingdom, YO31 8HE
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    • Alabama
      • Huntsville, Alabama, United States, 35801
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      • Cottonwood, Arizona, United States, 86326
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      • Tucson, Arizona, United States, 85724
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    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
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      • Bakersfield, California, United States, 93308
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      • Indianapolis, Indiana, United States, 46237
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      • 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

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
Intervention / Treatment
EXPERIMENTAL: Losmapimod
Losmapimod 7.5 mg twice daily oral tablet
Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets.
Other Names:
  • GW856553
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
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.
Subjects will receive placebo as film-coated, round, plain faced tablets.

What is the study measuring?

Primary Outcome Measures

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

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

Collaborators

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.

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)

June 3, 2014

Primary Completion (ACTUAL)

December 14, 2015

Study Completion (ACTUAL)

December 14, 2015

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (ESTIMATE)

May 23, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

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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