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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT02742103
Eligibility Criteria:
Inclusion Criteria:
• Men or women, at least 18 years of age, with evidence of moderate renal impairment (an eGFR ≥ 30 and \<60 mL/min/1.73 m2) and myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI).
Exclusion Criteria:
* Symptoms, biomarker elevation or electrocardiogram (ECG) changes other than those of the index event that are consistent with a diagnosis of AMI but are likely not due to primary myocardial ischemia
* Ongoing hemodynamic instability
* Planned coronary artery bypass surgery
* Evidence of hepatobiliary disease
* History of acute kidney injury (AKI) after previous exposure to an intravenous contrast agent.
* History of nephrotic range proteinuria.
* Known history of allergy to soy beans or peanuts, immunoglobulin A (IgA) deficiency, antibodies to IgA , or hypersensitivity to CSL112 or any of its components.
* Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02742103
Study Brief:
Protocol Section:
NCT02742103