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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02145468




Registration number
NCT02145468
Ethics application status
Date submitted
15/05/2014
Date registered
23/05/2014
Date last updated
2/06/2017

Titles & IDs
Public title
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)
Scientific 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.
Secondary ID [1] 0 0
116197
Universal Trial Number (UTN)
Trial acronym
LATITUDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Losmapimod 7.5 mg twice daily
Treatment: Drugs - Placebo twice daily
Treatment: Drugs - Standard therapy

Experimental: Losmapimod - Losmapimod 7.5 mg twice daily oral tablet

Placebo Comparator: Placebo - Placebo twice daily oral tablet


Treatment: Drugs: Losmapimod 7.5 mg twice daily
Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets.

Treatment: Drugs: Placebo twice daily
Subjects will receive placebo as film-coated, round, plain faced tablets.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12
Timepoint [1] 0 0
Up to 12 weeks
Secondary outcome [1] 0 0
Number of Participants With First Occurrence of MACE Through Week 24
Timepoint [1] 0 0
Up to Week 24
Secondary outcome [2] 0 0
Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24
Timepoint [2] 0 0
Week 12 and Week 24
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Week 12 and Week 24
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Week 12, Week 24
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Week 12, Week 24
Secondary outcome [6] 0 0
Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and Week 24
Timepoint [6] 0 0
Week 12, Week 24
Secondary outcome [7] 0 0
Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and Week 24
Timepoint [7] 0 0
Week 12, Week 24
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Week 12, Week 24
Secondary outcome [9] 0 0
Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and Week 24
Timepoint [9] 0 0
Week 12, Week 24
Secondary outcome [10] 0 0
Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and Week 24
Timepoint [10] 0 0
Week 12, Week 24
Secondary outcome [11] 0 0
Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and Week 24
Timepoint [11] 0 0
Week 12, Week 24
Secondary outcome [12] 0 0
Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and Week 24
Timepoint [12] 0 0
Week 12, Week 24
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Week 12, Week 24
Secondary outcome [14] 0 0
Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and Week 24
Timepoint [14] 0 0
Week 12, Week 24
Secondary outcome [15] 0 0
Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and Week 24
Timepoint [15] 0 0
Week 12, Week 24
Secondary outcome [16] 0 0
Number of Participants Re-hospitalized Within 30 Days of Discharge
Timepoint [16] 0 0
Within up to 30 days of post discharge
Secondary outcome [17] 0 0
Number of Participants With All-cause Mortality Through to Week 12 and Week 24
Timepoint [17] 0 0
Week 12, Week 24
Secondary outcome [18] 0 0
Number of Participants With CV Death Events Through to Week 12 and Week 24
Timepoint [18] 0 0
Week 12, Week 24
Secondary outcome [19] 0 0
Number of Participants With CHD Death Events Through to Week 12 and Week 24
Timepoint [19] 0 0
Week 12, Week 24
Secondary outcome [20] 0 0
Number of Participants With First Occurrence of Myocardial Infarction (Fatal and Non-fatal) Events Through to Week 12 and Week 24
Timepoint [20] 0 0
Week 12, Week 24
Secondary outcome [21] 0 0
Number of Participants With First Occurrence of Type I (Spontaneous) MI Events Through to Week 12 and Week 24
Timepoint [21] 0 0
Week 12, Week 24
Secondary outcome [22] 0 0
Number of Participants With First Occurrence of SRI-UR Events Through to Week 12 and Week 24
Timepoint [22] 0 0
Week 12, Week 24
Secondary outcome [23] 0 0
Number of Participants With First Occurrence of Stroke (Fatal and Non-fatal) Events Through to Week 12 and Week 24
Timepoint [23] 0 0
Week 12, Week 24
Secondary outcome [24] 0 0
Number of Participants With First Occurrence of Hospitalization for HF Through to Week 12 and Week 24
Timepoint [24] 0 0
Week 12, Week 24
Secondary outcome [25] 0 0
Number of Participants With First Occurrence of Any Unplanned Coronary Revascularization Through to Week 12 and Week 24
Timepoint [25] 0 0
Week 12, Week 24

Eligibility
Key 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
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/12/2015
Sample size
Target
Accrual to date
Final
3503
Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Brisbane
Recruitment hospital [2] 0 0
GSK Investigational Site - Cairns
Recruitment hospital [3] 0 0
GSK Investigational Site - Herston
Recruitment hospital [4] 0 0
GSK Investigational Site - Nambour
Recruitment hospital [5] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [6] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [7] 0 0
GSK Investigational Site - Epping
Recruitment hospital [8] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [9] 0 0
GSK Investigational Site - Murdoch
Recruitment hospital [10] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
4032 - Brisbane
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4560 - Nambour
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
3076 - Epping
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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Florida
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Georgia
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Idaho
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United States of America
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Illinois
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United States of America
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Indiana
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Iowa
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Louisiana
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Maine
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Massachusetts
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Michigan
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Praha 2
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Praha 6
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Czechia
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Usti nad Labem
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Zlin
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Hellerup
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Hvidovre
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København NV
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Denmark
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København S
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Tallinn
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Estonia
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Tartu
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Besançon Cedex
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France
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Dijon
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France
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Nantes cedex 1
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France
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Paris Cedex 18
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Pau
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Toulouse cedex 09
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France
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Tourcoing cedex
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Valenciennes Cedex
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Germany
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Baden-Wuerttemberg
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Germany
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Brandenburg
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Sachsen
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Germany
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Hamburg
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Greece
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Alexandroupolis
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Greece
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Athens
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Greece
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Chalkida
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Greece
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N. Efkarpia, Thessaloniki
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Greece
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Thessaloniki
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Hong Kong
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Chai Wan
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Hong Kong
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Kowloon
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Hong Kong
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Shatin, New Territories
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Budapest
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Szolnok
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Israel
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Ashkelon
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Israel
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Haddera
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Israel
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Kfar Saba
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Israel
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Israel
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Tel Aviv
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Umbria
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Korea, Republic of
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Daejeon
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Ganwon-do
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Gwangju
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Seoul
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Jalisco
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Amersfoort
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Amsterdam
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Delft
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Deventer
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Helmond
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Nieuwegein
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Nijmegen
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Rotterdam
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Schiedam
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Sittard-geleen
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Tilburg
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Zwolle
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Christchurch
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Grafton, Auckland
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New Zealand
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Hamilton
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New Zealand
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New Plymouth
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New Zealand
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Otahuhu, Auckland
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New Zealand
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Wellington South
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Norway
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Lillehammer
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Oslo
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Skien
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Stavanger
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Philippines
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Manila
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Pasig City
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Quezon City
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Philippines
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San Juan
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Gdansk
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Gdynia
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Krakow
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Lubin
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Lublin
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Torun
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Walbrzych
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Warszawa
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Wroclaw
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Romania
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Bucharest
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Craiova
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Russian Federation
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Barnaul
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Gatchina
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Irkutsk
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Russian Federation
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York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The TIMI Study Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02145468
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02145468