Clinical trial NCT02145468 (phase 3, status: completed)
Conditions: acute coronary syndrome
ICD codes: I24.0
Drugs: losmapimod 7.5 mg twice daily, placebo twice daily, standard therapy
SMILES: CC1=C(C=C(C=C1F)C(=O)NC1CC1)C1=CC=C(C=N1)C(=O)NCC(C)(C)C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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