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)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02145468
• Date of registration: 15/05/2014
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• 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) LATITUDE
• 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.
• Date of first enrolment: June 3, 2014
• Target sample size: 3503
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02145468
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czech Republic, Czechia, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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



Age minimum: 35 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Coronary Syndrome

Intervention(s)

Drug: Losmapimod 7.5 mg twice daily

Drug: Standard therapy

Drug: Placebo twice daily

Primary Outcome(s)

Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12 [Time Frame: Up to 12 weeks]

Secondary Outcome(s)

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 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, 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 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 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 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 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, MI 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 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 CV Death Events 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 [Time Frame: 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 All-cause Mortality 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 [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 [Time Frame: Week 12, Week 24]

Number of Participants Re-hospitalized Within 30 Days of Discharge [Time Frame: Within up to 30 days of post discharge]

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 MACE Through Week 24 [Time Frame: Up to 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 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 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 Type I (Spontaneous) MI 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 [Time Frame: 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 the Composite of CV Death or MI up to Week 12 and Week 24 [Time Frame: Week 12 and Week 24]

Secondary ID(s)

116197

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The TIMI Study Group

Results

• Results available: Yes
• Date Posted: 02/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02145468