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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT03791593
Eligibility Criteria:
Inclusion Criteria:
1. Signing of the informed consent
2. Patient ≥18 years and ≤80 years of age
3. LVEF \<40%
4. Ischemic etiology (evidence of at least one acute coronary event and/or CAD by coronary angiography or multi slice CT)
5. New York Heart Association (NYHA) class II
6. NT-proBNP ≥ 400 pg/mL
7. Hs-TnT \>10 pg/mL
8. LDL ≥ 70 mg/dL
9. Stable CAD (last ACS before the last 3 months)
10. GDMT according to 2016 ESC HF guidelines for at least the last 3 months.
11. Statin treatment, whichever dose the patient receives at the time of enrolment, stable for at least 1 month, without need to statin uptitration.
Exclusion Criteria:
1. Extracardiac disease with estimated life expectancy less than 1 year
2. Contraindication to receiving evolocumab
3. Hypersensitivity to the active substance or to any of the excipients
4. Female subject who has not used an acceptable method of birth control for at least 1 month prior to screening and/or is not willing to inform her partner of her participation in this clinical trial and to use an acceptable method of effective birth control during treatment with evolocumab and for an additional 15 weeks after the end of treatment with evolocumab, unless the female subject is permanently sterilized or postmenopausal:
A female is considered of childbearing potential unless permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or postmenopausal with menopause defined as:
* Age ≥55 years and ≥12 months of spontaneous and continuous amenorrhea, or
* Age \<55 years but no spontaneous menses for ≥2 years, or
* Age \<55 years and spontaneous menses within the past 1 year, but currently amenorrheic, AND with follicle-stimulating hormone (FSH) levels \>40 IU/L or estradiol levels \<5 ng/dL or according to the definition of "postmenopausal range" for the laboratory involved.
5. Patient \<18 or ≥ 81 years
6. Liver dysfunction (AST or ALT\> 3 times the upper limit of normal value).
7. Severe renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73m²) or renal replacement therapy at screening (CKD-EPI equation).
8. Coronary revascularization in the 3 months prior to randomization or pending coronary revascularization.
9. Previous haemorrhagic stroke
10. Uncontrolled hypertension (systolic blood pressure ≥ 140 or/and diastolic blood pressure ≥ 90 mmHg) either on or off therapy at screening or at baseline
11. Uncontrolled hypothyroidism or hyperthyroidism
12. Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (HbA1c \> 8.5%)
13. Uncontrolled cardiac arrhythmia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03791593
Study Brief:
Protocol Section:
NCT03791593