AzTrials
AzTrials

Acute Coronary SyndromePhase 3LATITUDENCT02145468

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)

A Phase 3 study testing Losmapimod 7.5 mg twice daily and Standard therapy in people with Acute Coronary Syndrome, run by GlaxoSmithKline at 341 sites in 34 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

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. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Losmapimod 7.5 mg twice daily and Standard therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,503 participants
Where
341 sitesin 34 countries
Study dates
3 Jun 2014to 14 Dec 2015
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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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

Trial locations and contacts

341 sites in 34 countries.

341 sites in 34 countries

United States91 sites

  • GSK Investigational Site

    Abington, Pennsylvania, 19001

  • GSK Investigational Site

    Albany, New York, 12208

  • GSK Investigational Site

    Alexandria, Louisiana, 71301

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Auburn, Maine, 04210

  • GSK Investigational Site

    Augusta, Georgia, 30901

  • GSK Investigational Site

    Aurora, Illinois, 60504

  • GSK Investigational Site

    Austin, Texas, 78756

  • GSK Investigational Site

    Bakersfield, California, 93308

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70809

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Canton, Ohio, 44710

  • GSK Investigational Site

    Chambersburg, Pennsylvania, 17201

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Chattanooga, Tennessee, 37404-1173

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Columbus, Ohio, 45215

  • GSK Investigational Site

    Cottonwood, Arizona, 86326

  • GSK Investigational Site

    Dallas, Texas, 75216

  • GSK Investigational Site

    Danville, Pennsylvania, 17822-2160

  • GSK Investigational Site

    Daytona Beach, Florida, 32117

  • GSK Investigational Site

    Dearborn, Michigan, 48124

  • GSK Investigational Site

    Denver, Colorado, 80204

  • GSK Investigational Site

    Doylestown, Pennsylvania, 18901

  • GSK Investigational Site

    Duluth, Minnesota, 55805

  • GSK Investigational Site

    Elmhurst, Illinois, 60126

  • GSK Investigational Site

    Flemington, New Jersey, 08822

  • GSK Investigational Site

    Grand Blanc, Michigan, 48439

  • GSK Investigational Site

    Greensboro, North Carolina, 27401

  • GSK Investigational Site

    Huntington Beach, California, 92648

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Indianapolis, Indiana, 46237

  • GSK Investigational Site

    Iowa City, Iowa, 52240

  • GSK Investigational Site

    Jacksonville, Florida, 32207

  • GSK Investigational Site

    Jacksonville, Florida, 32209

  • GSK Investigational Site

    Jacksonville Beach, Florida, 32250

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Littleton, Colorado, 80120

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Manitowoc, Wisconsin, 54220

  • GSK Investigational Site

    Mansfield, Ohio, 44906

  • GSK Investigational Site

    Marquette, Michigan, 49855

  • GSK Investigational Site

    Minneapolis, Minnesota, 55407

  • GSK Investigational Site

    Mission Viejo, California, 92691

  • GSK Investigational Site

    Monterey, California, 93940

  • GSK Investigational Site

    Morgantown, West Virginia, 26506

  • GSK Investigational Site

    Muncie, Indiana, 47303

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Nashville, Tennessee, 37205

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73135

  • GSK Investigational Site

    Omaha, Nebraska, 68124

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Pensacola, Florida, 32501

  • GSK Investigational Site

    Poughkeepsie, New York, 12601

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Raleigh, North Carolina, 27610

  • GSK Investigational Site

    Rapid City, South Dakota, 57701

  • GSK Investigational Site

    Ridgewood, New Jersey, 07450

  • GSK Investigational Site

    Roanoke, Virginia, 24014

  • GSK Investigational Site

    Rochester, Michigan, 48307

  • GSK Investigational Site

    Rome, Georgia, 30165

  • GSK Investigational Site

    Round Rock, Texas, 78681

  • GSK Investigational Site

    Saint Paul, Minnesota, 55101

  • GSK Investigational Site

    San Diego, California, 92161

  • GSK Investigational Site

    Slidell, Louisiana, 70458

  • GSK Investigational Site

    Springfield, Missouri, 65804

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Stony Brook, New York, 11794

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    Tampa, Florida, 33613

  • GSK Investigational Site

    Teaneck, New Jersey, 07666

  • GSK Investigational Site

    Torrance, California, 90509

  • GSK Investigational Site

    Troy, Michigan, 48085

  • GSK Investigational Site

    Tucson, Arizona, 85713

  • GSK Investigational Site

    Tucson, Arizona, 85724

  • GSK Investigational Site

    Vero Beach, Florida, 32960

  • GSK Investigational Site

    Victoria, Texas, 77901

  • GSK Investigational Site

    Voorhees Township, New Jersey, 08043

  • GSK Investigational Site

    Wausau, Wisconsin, 54401

  • GSK Investigational Site

    West Des Moines, Iowa, 50266

  • GSK Investigational Site

    Wilkes-Barre, Pennsylvania, 18702

  • GSK Investigational Site

    York, Pennsylvania, 17403

  • GSK Investigational Site

    Ypsilanti, Michigan, 48197

  • GSK Investigational Site

    Zachary, Louisiana, 70791

  • GSK Investigational Site

    Zanesville, Ohio, 43701

Other trials in United States

Germany24 sites

  • GSK Investigational Site

    Aachen, North Rhine-Westphalia, 52074

  • GSK Investigational Site

    Bad Krozingen, Baden-Wurttemberg, 79189

  • GSK Investigational Site

    Bad Nauheim, Hesse, 61231

  • GSK Investigational Site

    Bernau bei Berlin, Brandenburg, 16321

  • GSK Investigational Site

    Bielefeld, North Rhine-Westphalia, 33604

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53127

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44137

  • GSK Investigational Site

    Esslingen am Neckar, Baden-Wurttemberg, 73730

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 65929

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Giessen, Hesse, 35392

  • GSK Investigational Site

    Hamburg, 20099

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    Hamburg, 22291

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Kassel, Hesse, 34121

  • GSK Investigational Site

    Langen, Hesse, 63225

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04289

  • GSK Investigational Site

    Leverkusen, North Rhine-Westphalia, 51375

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68167

  • GSK Investigational Site

    Mönchengladbach, North Rhine-Westphalia, 41063

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70376

  • GSK Investigational Site

    Wuppertal, North Rhine-Westphalia, 42117

Other trials in Germany

Russia20 sites

  • GSK Investigational Site

    Barnaul, 656055

  • GSK Investigational Site

    Gatchina, 188300

  • GSK Investigational Site

    Irkutsk, 664049

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Moscow, 111539

  • GSK Investigational Site

    Moscow, 117292

  • GSK Investigational Site

    Moscow, 121374

  • GSK Investigational Site

    Moscow, 121552

  • GSK Investigational Site

    Novosibirsk, 630008

  • GSK Investigational Site

    Perm, 614107

  • GSK Investigational Site

    Ryazan, 390026

  • GSK Investigational Site

    Ryazan, 390039

  • GSK Investigational Site

    Saint Petersburg, 190000

  • GSK Investigational Site

    Saint Petersburg, 192242

  • GSK Investigational Site

    Saint Petersburg, 199106

  • GSK Investigational Site

    Samara, 443070

  • GSK Investigational Site

    Saratov, 410012

  • GSK Investigational Site

    Saratov, 410028

  • GSK Investigational Site

    Tomsk, 634012

  • GSK Investigational Site

    Tyumen, 625023

Other trials in Russia

Netherlands14 sites

  • GSK Investigational Site

    Alkmaar, 1815 JD

  • GSK Investigational Site

    Amersfoort, 3813 TZ

  • GSK Investigational Site

    Amsterdam, 1091 AC

  • GSK Investigational Site

    Delft, 2625 AD

  • GSK Investigational Site

    Deventer, 7416 SE

  • GSK Investigational Site

    Helmond, 5707 HA

  • GSK Investigational Site

    Nieuwegein, 3435 CM

  • GSK Investigational Site

    Nijmegen, 6532 SZ

  • GSK Investigational Site

    Rotterdam, 3045 PM

  • GSK Investigational Site

    Schiedam, 3118 JH

  • GSK Investigational Site

    Sittard-geleen, 6162 BG

  • GSK Investigational Site

    Tilburg, 5042 AD

  • GSK Investigational Site

    Venlo, 5912 BL

  • GSK Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Poland12 sites

  • GSK Investigational Site

    Bydgoszcz, 85-094

  • GSK Investigational Site

    Gdansk, 80-952

  • GSK Investigational Site

    Gdynia, 81-348

  • GSK Investigational Site

    Inowrocław, 88-100

  • GSK Investigational Site

    Krakow, 31-202

  • GSK Investigational Site

    Lubin, 59-301

  • GSK Investigational Site

    Lublin, 20-954

  • GSK Investigational Site

    Olsztyn, 10-561

  • GSK Investigational Site

    Torun, 87-100

  • GSK Investigational Site

    Wałbrzych, 58-309

  • GSK Investigational Site

    Warsaw, 04-073

  • GSK Investigational Site

    Wroclaw, 50-556

Other trials in Poland

Spain12 sites

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Galdakano, 48960

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Majadahonda (Madrid), 28222

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Marid, 28040

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Seville, 41071

Other trials in Spain

Czechia11 sites

  • GSK Investigational Site

    Brno, 625 00

  • GSK Investigational Site

    České Budějovice, 370 01

  • GSK Investigational Site

    Hradec Králové, 500 05

  • GSK Investigational Site

    Liberec, 460 63

  • GSK Investigational Site

    Ostrava, 708 52

  • GSK Investigational Site

    Pardubice, 523 03

  • GSK Investigational Site

    Prague, 101 00

  • GSK Investigational Site

    Prague, 128 08

  • GSK Investigational Site

    Prague, 169 02

  • GSK Investigational Site

    Ústí nad Labem, 401 13

  • GSK Investigational Site

    Zlín, 762 75

Other trials in Czechia

Australia10 sites

  • GSK Investigational Site

    Bedford Park, South Australia, 5042

  • GSK Investigational Site

    Brisbane, Queensland, 4032

  • GSK Investigational Site

    Cairns, Queensland, 4870

  • GSK Investigational Site

    Epping, Victoria, 3076

  • GSK Investigational Site

    Geelong, Victoria, 3220

  • GSK Investigational Site

    Herston, Queensland, 4029

  • GSK Investigational Site

    Hobart, Tasmania, 7000

  • GSK Investigational Site

    Murdoch, Western Australia, 6150

  • GSK Investigational Site

    Nambour, Queensland, 4560

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

Other trials in Australia

Belgium10 sites

  • GSK Investigational Site

    Aalst, 9300

  • GSK Investigational Site

    Bonheiden, 2820

  • GSK Investigational Site

    Brasschaat, 2930

  • GSK Investigational Site

    Bruges, 8000

  • GSK Investigational Site

    Genk, 3600

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

  • GSK Investigational Site

    Mechelen, 2800

  • GSK Investigational Site

    Yvoir, 5530

Other trials in Belgium

France10 sites

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    Montauban, 82017

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Paris, 75877

  • GSK Investigational Site

    Pau, 64000

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Tourcoing, 59208

  • GSK Investigational Site

    Valenciennes, 59322

Other trials in France

Canada9 sites

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E5J1

  • GSK Investigational Site

    Kitchener, Ontario, N2M 1B2

  • GSK Investigational Site

    Montreal, Quebec, H1T 1C8

  • GSK Investigational Site

    Scarborough Village, Ontario, M1E 5E9

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    Surrey, British Columbia, V3V 1Z2

  • GSK Investigational Site

    Thunder Bay, Ontario, P7B 6V4

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • GSK Investigational Site

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

South Korea8 sites

  • GSK Investigational Site

    Daejeon, 301-721

  • GSK Investigational Site

    Ganwon-do, 220-701

  • GSK Investigational Site

    Gwangju, 501-757

  • GSK Investigational Site

    Seoul, 110-774

  • GSK Investigational Site

    Seoul, 134-727

  • GSK Investigational Site

    Seoul, 135-720

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 152-703

Other trials in South Korea

Sweden8 sites

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Gothenburg, SE-416 85

  • GSK Investigational Site

    Helsingborg, SE-251 87

  • GSK Investigational Site

    Jönköping, SE-551 85

  • GSK Investigational Site

    Örebro, SE-701 85

  • GSK Investigational Site

    Östersund, SE-831 83

  • GSK Investigational Site

    Stockholm, SE-118 83

  • GSK Investigational Site

    Västerås, SE-721 89

Other trials in Sweden

Italy7 sites

  • GSK Investigational Site

    Bergamo, Lombardy, 24127

  • GSK Investigational Site

    Cremona, Lombardy, 26100

  • GSK Investigational Site

    Milan, Lombardy, 20138

  • GSK Investigational Site

    Milan, Lombardy, 20162

  • GSK Investigational Site

    Parma, Emilia-Romagna, 43100

  • GSK Investigational Site

    Perugia, Umbria, 06156

  • GSK Investigational Site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Ukraine7 sites

  • GSK Investigational Site

    Cherkassy, 18009

  • GSK Investigational Site

    Ivano-Frankivsk, 76018

  • GSK Investigational Site

    Kharkiv, 61018

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Lviv, 79015

  • GSK Investigational Site

    Uzhhorod, 88014

  • GSK Investigational Site

    Zaporizhzhya, 69000

Other trials in Ukraine

Argentina6 sites

  • GSK Investigational Site

    Buenos Aires, C1428DCO

  • GSK Investigational Site

    Corrientes, W3400AMZ

  • GSK Investigational Site

    Quilmes, Buenos Aires, B1878DFK

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000DSR

  • GSK Investigational Site

    Santa Fe, S3000AZG

  • GSK Investigational Site

    Venado Tuerto, Santa Fe Province, 2600

Other trials in Argentina

Bulgaria6 sites

  • GSK Investigational Site

    Blagoevgrad, 2700

  • GSK Investigational Site

    Dimitrovgrad, 6400

  • GSK Investigational Site

    Pazardzhik, 4400

  • GSK Investigational Site

    Sofia, 1000

  • GSK Investigational Site

    Sofia, 1407

  • GSK Investigational Site

    Sofia, 1572

Other trials in Bulgaria

Greece6 sites

  • GSK Investigational Site

    Alexandroupoli, 68100

  • GSK Investigational Site

    Athens, 115 26

  • GSK Investigational Site

    Athens, 115 28

  • GSK Investigational Site

    Chalcis, 341 00

  • GSK Investigational Site

    N. Efkarpia, Thessaloniki, 56429

  • GSK Investigational Site

    Thessaloniki, 570 10

Other trials in Greece

New Zealand6 sites

  • GSK Investigational Site

    Christchurch, 8011

  • GSK Investigational Site

    Grafton, Auckland, 1030

  • GSK Investigational Site

    Hamilton, 3204

  • GSK Investigational Site

    New Plymouth, 4310

  • GSK Investigational Site

    Otahuhu, Auckland, 1640

  • GSK Investigational Site

    Wellington South, 6021

Other trials in New Zealand

South Africa6 sites

  • GSK Investigational Site

    Bellville, 7530

  • GSK Investigational Site

    Cape Town, 7505

  • GSK Investigational Site

    Kuils River, 7580

  • GSK Investigational Site

    Parktown West, 2193

  • GSK Investigational Site

    Pinelands, 7405

  • GSK Investigational Site

    Somerset West, 7130

Other trials in South Africa

United Kingdom6 sites

  • GSK Investigational Site

    Basingstoke, RG24 9NA

  • GSK Investigational Site

    Bournemouth, BH7 7DW

  • GSK Investigational Site

    Dundee, DD1 9SY

  • GSK Investigational Site

    Edinburgh, EH16 4SA

  • GSK Investigational Site

    Newcastle upon Tyne, NE7 7DN

  • GSK Investigational Site

    York, YO31 8HE

Other trials in United Kingdom

Hungary5 sites

  • GSK Investigational Site

    Balatonfüred, 8230

  • GSK Investigational Site

    Budapest, 1122

  • GSK Investigational Site

    Budapest, 1134

  • GSK Investigational Site

    Szolnok, 5004

  • GSK Investigational Site

    Zalaegerszeg, 8900

Other trials in Hungary

Israel5 sites

  • GSK Investigational Site

    Ashkelon, 78278

  • GSK Investigational Site

    Haddera, 38100

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Nahariya, 22100

  • GSK Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Norway5 sites

  • GSK Investigational Site

    Lillehammer, 2629

  • GSK Investigational Site

    Oslo, 0407

  • GSK Investigational Site

    Skien, N-3710

  • GSK Investigational Site

    Stavanger, 4011

  • GSK Investigational Site

    Tromsø, 9038

Other trials in Norway

Taiwan5 sites

  • GSK Investigational Site

    Changhua, 500

  • GSK Investigational Site

    Hualien City, 970

  • GSK Investigational Site

    Kaohsiung City, 813

  • GSK Investigational Site

    Taipei, 104

  • GSK Investigational Site

    Taipei, 112

Other trials in Taiwan

Chile4 sites

  • GSK Investigational Site

    Concepción, Región Del Biobio, 4070038

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8330024

  • GSK Investigational Site

    Santiago, 8207257

  • GSK Investigational Site

    Temuco, Región de La Araucania

Other trials in Chile

Denmark4 sites

  • GSK Investigational Site

    Hellerup, DK-2900

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    København NV, DK-2400

  • GSK Investigational Site

    København S, DK-2300

Other trials in Denmark

Philippines4 sites

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Pasig, 1600

  • GSK Investigational Site

    Quezon City, 1100

  • GSK Investigational Site

    San Juan City, 1500

Other trials in Philippines

Slovakia4 sites

  • GSK Investigational Site

    Bratislava, 833 48

  • GSK Investigational Site

    Košice, 040 11

  • GSK Investigational Site

    Martin, 036 59

  • 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, 10138

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Hong Kong3 sites

  • GSK Investigational Site

    Chai Wan

  • GSK Investigational Site

    Kowloon

  • GSK Investigational Site

    Shatin, New Territories

Other trials in Hong Kong

Mexico3 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44280

  • GSK Investigational Site

    Querétaro, 76000

  • GSK Investigational Site

    San Luis Potosí City, 78240

Other trials in Mexico

Romania3 sites

  • GSK Investigational Site

    Bucharest, 014461

  • GSK Investigational Site

    Bucharest, 050098

  • GSK Investigational Site

    Craiova, 200642

Other trials in Romania

About this study

Official title: 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.

Being tested
Losmapimod 7.5 mg twice daily, Placebo twice daily, Standard therapy
Keywords
Myocardial infarction, Acute coronary syndrome, Cardiovascular disease, p38 mitogen-activated protein kinase (MAPK) inhibitor, NSTEMI, Losmapimod, STEMI
Medical subject headings
Acute Coronary Syndrome, Myocardial Infarction, Cardiovascular Diseases, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction

What participants receive

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

  • Losmapimod 7.5 mg twice dailyDrug

    Also called GW856553

    Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets.

  • Placebo twice dailyDrug

    Subjects will receive placebo as film-coated, round, plain faced tablets.

  • Standard therapyDrug

    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.

Study groups in NCT02145468
Study groupRoleWhat they receive
LosmapimodExperimentalLosmapimod 7.5 mg twice daily oral tablet
Receives: Drug: Losmapimod 7.5 mg twice daily; Drug: Standard therapy
PlaceboPlacebo comparatorPlacebo twice daily oral tablet
Receives: Drug: Placebo twice daily; Drug: Standard therapy

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 Major Adverse Cardiovascular Events (MACE) Through Week 12

    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.

    Measured: Up to 12 weeks

Secondary outcomes (25)

  1. Number of Participants With First Occurrence of MACE Through 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.

    Measured: Up to Week 24

  2. Number of Participants With First Occurrence of the Composite of CV Death or MI up to 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.

    Measured: Week 12 and Week 24

  3. 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.

    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.

    Measured: Week 12 and Week 24

  4. 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

    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.

    Measured: Week 12, Week 24

  5. 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

    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.

    Measured: Week 12, Week 24

  6. Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and 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.

    Measured: Week 12, Week 24

  7. Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and 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.

    Measured: Week 12, Week 24

  8. 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

    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.

    Measured: Week 12, Week 24

  9. Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and 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.

    Measured: Week 12, Week 24

  10. Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and 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.

    Measured: Week 12, Week 24

  11. Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and 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.

    Measured: Week 12, Week 24

  12. Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and 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.

    Measured: Week 12, Week 24

  13. 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

    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.

    Measured: Week 12, Week 24

  14. Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and 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.

    Measured: Week 12, Week 24

  15. Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and 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.

    Measured: Week 12, Week 24

  16. Number of Participants Re-hospitalized Within 30 Days of 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.

    Measured: Within up to 30 days of post discharge

  17. Number of Participants With All-cause Mortality Through to Week 12 and Week 24

    Number of participants with all-cause mortality through to Week 12 and Week 24 are presented.

    Measured: Week 12, Week 24

  18. Number of Participants With CV Death Events Through to Week 12 and Week 24

    Number of participants with CV death events through to Week 12 and Week 24 are presented.

    Measured: Week 12, Week 24

  19. Number of Participants With CHD Death Events Through to Week 12 and Week 24

    Number of participants with CHD death events through to Week 12 and Week 24 are presented.

    Measured: Week 12, Week 24

  20. Number of Participants With First Occurrence of Myocardial Infarction (Fatal and Non-fatal) Events Through to Week 12 and 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.

    Measured: Week 12, Week 24

  21. Number of Participants With First Occurrence of Type I (Spontaneous) MI Events Through to Week 12 and Week 24

    Number of participants with first occurrence of type I (spontaneous) MI events through to Week 12 and Week 24 are presented.

    Measured: Week 12, Week 24

  22. Number of Participants With First Occurrence of SRI-UR Events Through to Week 12 and Week 24

    Number of participants with first occurrence of SRI-UR events through to Week 12 and Week 24 are presented.

    Measured: Week 12, Week 24

  23. Number of Participants With First Occurrence of Stroke (Fatal and Non-fatal) Events Through to Week 12 and Week 24

    Number of participants with first occurrence of stroke (fatal and non-fatal) events through to Week 12 and Week 24 are presented.

    Measured: Week 12, Week 24

  24. Number of Participants With First Occurrence of Hospitalization for HF Through to Week 12 and Week 24

    Number of participants with first occurrence of hospitalization for HF through to Week 12 and Week 24 are presented.

    Measured: Week 12, Week 24

  25. Number of Participants With First Occurrence of Any Unplanned Coronary Revascularization Through to Week 12 and Week 24

    Number of participants with first occurrence of any unplanned coronary revascularization through to Week 12 and Week 24 are presented.

    Measured: Week 12, Week 24

Timeline

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

  1. First posted23 May 2014 (estimated)
  2. Study start3 Jun 2014
  3. Primary completion14 Dec 2015
  4. Study completion14 Dec 2015

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
Double blind
Who is masked
Participant, Care provider
Enrolment
3,503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02145468
Sponsor's protocol ID
116197
Acronym
LATITUDE
Status last verified
Mar 2017
First submitted
15 May 2014
Last updated
2 Jun 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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

  • Cavender MA, O'Donoghue ML, Abbate A, Aylward P, Fox KA, Glaser RX, Park JG, Lopez-Sendon J, Steg PG, Sabatine MS, Morrow DA. Inhibition of p38 MAP kinase in patients with ST-elevation myocardial infarction - findings from the LATITUDE-TIMI 60 trial. Am Heart J. 2022 Jan;243:147-157. doi: 10.1016/j.ahj.2021.08.022. Epub 2021 Sep 8.

    PubMed 34508693

  • O'Donoghue ML, Glaser R, Cavender MA, Aylward PE, Bonaca MP, Budaj A, Davies RY, Dellborg M, Fox KA, Gutierrez JA, Hamm C, Kiss RG, Kovar F, Kuder JF, Im KA, Lepore JJ, Lopez-Sendon JL, Ophuis TO, Parkhomenko A, Shannon JB, Spinar J, Tanguay JF, Ruda M, Steg PG, Theroux P, Wiviott SD, Laws I, Sabatine MS, Morrow DA; LATITUDE-TIMI 60 Investigators. Effect of Losmapimod on Cardiovascular Outcomes in Patients Hospitalized With Acute Myocardial Infarction: A Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1591-9. doi: 10.1001/jama.2016.3609.

    PubMed 27043082

  • O'Donoghue ML, Glaser R, Aylward PE, Cavender MA, Crisp A, Fox KA, Laws I, Lopez-Sendon JL, Steg PG, Theroux P, Sabatine MS, Morrow DA. Rationale and design of the LosmApimod To Inhibit p38 MAP kinase as a TherapeUtic target and moDify outcomes after an acute coronary syndromE trial. Am Heart J. 2015 May;169(5):622-630.e6. doi: 10.1016/j.ahj.2015.02.012. Epub 2015 Feb 23.

    PubMed 25965709

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Losmapimod 7.5 mg twice daily and Standard therapy in people with Acute Coronary Syndrome, run by GlaxoSmithKline at 341 sites in 34 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 11 inclusion and 16 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 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 341 sites in United States, Germany, Russia, Netherlands, Poland and 29 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 2 Jun 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 Major Adverse Cardiovascular Events (MACE) Through Week 12 (time frame: Up to 12 weeks). 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 NCT02145468, which also lists 3 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 2 Jun 2017.

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