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)
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Lead
GlaxoSmithKline
With
The TIMI Study Group
Age
35–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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)
