Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT02145468
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT02145468
Study Brief:
Protocol Section:
NCT02145468