Clinical trial NCT02145468: 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)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Keywords: Myocardial infarction
Acute coronary syndrome
Cardiovascular disease
p38 mitogen-activated protein kinase (MAPK) inhibitor
NSTEMI
Losmapimod
STEMI
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: The TIMI Study Group
First posted: 2014-05-23
Enrollment: 3503
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Number of Participants With First Occurrence of MACE Through Week 24
timeFrame: Up to Week 24
measure: Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24
timeFrame: Week 12 and Week 24
measure: 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.
timeFrame: Week 12 and Week 24
measure: 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
timeFrame: Week 12, Week 24
measure: 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
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: 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
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: 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
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants Re-hospitalized Within 30 Days of Discharge
timeFrame: Within up to 30 days of post discharge
measure: Number of Participants With All-cause Mortality Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With CV Death Events Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With CHD Death Events Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of Myocardial Infarction (Fatal and Non-fatal) Events Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of Type I (Spontaneous) MI Events Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of SRI-UR Events Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of Stroke (Fatal and Non-fatal) Events Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of Hospitalization for HF Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
measure: Number of Participants With First Occurrence of Any Unplanned Coronary Revascularization Through to Week 12 and Week 24
timeFrame: Week 12, Week 24
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Cottonwood
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
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city: Huntington Beach
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city: Jacksonville
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city: Ocala
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city: Pensacola
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state: Florida
city: Tallahassee
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city: Rome
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city: Leuven
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city: Liège
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city: Mechelen
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city: Yvoir
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facility: GSK Investigational Site
city: Blagoevgrad
country: Bulgaria
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city: Dimitrovgrad
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facility: GSK Investigational Site
city: Pazardjik
country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Sofia
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city: Sofia
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city: Surrey
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facility: GSK Investigational Site
state: British Columbia
city: Vancouver
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facility: GSK Investigational Site
state: British Columbia
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state: British Columbia
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state: Ontario
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state: Ontario
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facility: GSK Investigational Site
state: Ontario
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state: Ontario
city: Montreal
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state: Quebec
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state: Quebec
city: Temuco
country: Chile
facility: GSK Investigational Site
state: Región De La Araucania
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facility: GSK Investigational Site
state: Región Del Biobio
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facility: GSK Investigational Site
state: Región Metro De Santiago
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city: Brno
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city: Hradec Kralove
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facility: GSK Investigational Site
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city: Besançon Cedex
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facility: GSK Investigational Site
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facility: GSK Investigational Site
state: Baden-Wuerttemberg
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state: Brandenburg
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city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Grafton, Auckland
country: New Zealand
facility: GSK Investigational Site
city: Hamilton
country: New Zealand
facility: GSK Investigational Site
city: New Plymouth
country: New Zealand
facility: GSK Investigational Site
city: Otahuhu, Auckland
country: New Zealand
facility: GSK Investigational Site
city: Wellington South
country: New Zealand
facility: GSK Investigational Site
city: Lillehammer
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Skien
country: Norway
facility: GSK Investigational Site
city: Stavanger
country: Norway
facility: GSK Investigational Site
city: Tromsø
country: Norway
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Pasig City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: San Juan
country: Philippines
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gdynia
country: Poland
facility: GSK Investigational Site
city: Inowroclaw
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lubin
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Walbrzych
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Craiova
country: Romania
facility: GSK Investigational Site
city: Barnaul
country: Russian Federation
facility: GSK Investigational Site
city: Gatchina
country: Russian Federation
facility: GSK Investigational Site
city: Irkutsk
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Perm
country: Russian Federation
facility: GSK Investigational Site
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: Samara
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Tyumen
country: Russian Federation
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Kosice
country: Slovakia
facility: GSK Investigational Site
city: Martin
country: Slovakia
facility: GSK Investigational Site
city: Nitra
country: Slovakia
facility: GSK Investigational Site
city: Bellville
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Kuils River
country: South Africa
facility: GSK Investigational Site
city: Parktown West
country: South Africa
facility: GSK Investigational Site
city: Pinelands
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Galdakano
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Majadahonda (Madrid)
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Marid
country: Spain
facility: GSK Investigational Site
city: Santiago De Compostela
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Helsingborg
country: Sweden
facility: GSK Investigational Site
city: Jönköping
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Västerås
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
city: Östersund
country: Sweden
facility: GSK Investigational Site
city: Changhua
country: Taiwan
facility: GSK Investigational Site
city: Hualien
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taipei City
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiangmai
country: Thailand
facility: GSK Investigational Site
city: Cherkassy
country: Ukraine
facility: GSK Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Lviv
country: Ukraine
facility: GSK Investigational Site
city: Uzhhorod
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: GSK Investigational Site
city: Basingstoke
country: United Kingdom
facility: GSK Investigational Site
city: Bournemouth
country: United Kingdom
facility: GSK Investigational Site
city: Dundee
country: United Kingdom
facility: GSK Investigational Site
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: GSK Investigational Site
city: York
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.