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:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT05579418
Eligibility Criteria:
Inclusion Criteria:
* Inclusion and exclusion criteria:
Inclusion Criteria
* Male or female ≥ 18 years of age and less than 80 years
* Hospitalized for a recent ACS-STEMI within 12 hours of onset of symptoms.
* Successful revascularization with PCI.
* LDL-C levels defined as follows:
* LDL-C ≥1.8 mmol/L in patients who have been receiving stable treatment with high-intensity statin within ≥ 4 weeks prior to enrollment (i.e., continuous treatment that has not changed with regard to statin intensity over the past 4 weeks)
* LDL-C ≥2.3 mmol/L in patients who have been receiving stable treatment with low- or moderate-intensity statin within ≥ 4 weeks prior to enrollment (i.e., continuous treatment that has not changed with regard to statin intensity over the past 4 weeks)
* LDL-C ≥3.2 mmol/L in patients who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment.
* Ability to understand the requirements of the study and to provide informed consent
Exclusion criteria
* Unstable clinical status (hemodynamic or electrical instability)
* Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation or flutter with rapid ventricular response not controlled by medications in the past 3 months prior to screening
* Severe renal dysfunction, defined by estimated glomerular filtration rate \<30 ml/min/1.73m2
* Active liver disease or hepatic dysfunction, either reported in patient medical record or defined by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \> 3x the upper limit of normal.
* Patient need urgent CABG
* patients symptoms onset is more than 12 hours.
* Reported intolerance to atorvastatin (any dose) OR statin intolerance defined by the following criteria:
* inability to tolerate at least 2 different statins (one statin at the lowest starting average daily dose and the other statin at any dose).
* intolerance associated with confirmed, intolerable statin-related adverse effect(s) or significant biomarker abnormalities.
* symptom or biomarker changes resolution or significant improvement upon dose decrease or discontinuation.
* Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel
* Known sensitivity to any substances or medication to be administered during the trial
* Patients who previously received Evolocumab or other PCSK9 inhibitor
* Treatment with systemic steroids or systemic cyclosporine in the past 3 months.
* Known active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator
* Patients who will not be available for study-required procedures in the judgment of the Investigator
* Current enrollment in another investigational device or drug study
* Active malignancy requiring treatment
* Pregnant women. For female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy, pregnancy is excluded by a pregnancy test prior to inclusion in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05579418
Study Brief:
Protocol Section:
NCT05579418