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 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT05976893
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 18 to ≤ 80 years of age
* Patients with very high risk of ASCVD (with any of the following):
1. Documented ASCVD, either clinical or unequivocal on imaging. Documented ASCVD includes previous acute coronary syndrome (ACS), stable angina, coronary revascularization (percutaneous coronary intervention, coronary artery bypass graft, and other arterial revascularization procedures), stroke and transient ischemic attack (TIA), and peripheral arterial disease. Unequivocally documented ASCVD on imaging includes those findings that are known to be predictive of clinical events, such as significant plaque on coronary angiography or computed tomography (CT) scan (multivessel coronary disease with two major epicardial arteries having \>50% stenosis), or on carotid ultrasound.
2. Diabetes mellitus (DM) with target organ damage, or at least three major risk factors, or early onset of type 1 diabetes mellitus (T1DM) of long duration (\>20 years).
* Patients have been diagnosed with cancer through histopathology and have a life expectancy of more than 1 year
* Fasting low-density lipoprotein cholesterol (LDL-C) ≥ 1.8 mmol/L or non-high-density lipoprotein cholesterol (non HDL-C) \> 2.6 mmol/L
* Participate voluntarily and sign an informed consent
* Negative serum Pregnancy test (in women with fertility potential)
Exclusion Criteria:
* Pregnant and lactating women
* During the study period and within 3 months of receiving the last dose of the study drug, women with fertility intentions and men unwilling to use effective contraceptive methods
* New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction \< 30%
* Uncontrolled hypertension, defined as systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg
* Plan for coronary revascularization or other cardiac surgery in recent (within 3 months after randomization)
* Severe renal insufficiency, defined as estimated glomerular filtration rate (eGRF) \< 30ml/min/1.73m2 or Serum creatinine (Scr) \> 221 umol/L
* Severe liver dysfunction, defined as an increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3 times above the upper limit of normal
* Have used PCSK9 inhibitors within 3 months before enrollment, or have a history of severe allergic reactions to PCSK9 inhibitors
* Severe infections requiring intravenous antibiotics
* HIV-positive or history of acquired immunodeficiency syndrome (AIDS)
* With cognitive impairment or psychiatric illnesses
* Participating in other trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05976893
Study Brief:
Protocol Section:
NCT05976893