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)

Status:	Active, not recruiting
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	35 - Any
Updated:	4/21/2016
Start Date:	June 2014
End Date:	December 2018

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.

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

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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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