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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04100434
Eligibility Criteria:
Inclusion Criteria:
* Recent hospitalization for acute coronary syndrome: Complies with the diagnostic criteria for acute coronary syndrome (non-ST-segment elevation myocardial infarction, acute ST-segment elevation myocardial infarction, and unstable angina within 72 hours of onset)
* LDL-C level (meet one of the following conditions):
1. Prior to the study, patients who received intensive statins for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥70 mg/dL (≥1.8 mmol/L) or non-HDL-C ≥100 mg /dL (≥2.6mmol/L) are included in the study;
2. Prior to the study, patients who received moderate-intensity statin therapy for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥90 mg/dL (≥2.3 mmol/L) or non-HDL-C≥ 120mg/dL (≥3.1mmol/L) are included in the study;
3. Prior to the study, patients who do not receive statin therapy or who do not continue to receive statin with LDL-C ≥ 125 mg/dL (≥ 3.2 mmol/L) or non-HDL-C ≥ 155 mg/dL (≥ 4.0 mmol/L).
* Being able to understand research requirements and sign informed consent
Exclusion Criteria:
* Unstable clinical status (hemodynamics or ECG instability)
* Uncontrolled arrhythmia, defined as recurrent or symptomatic ventricular tachycardia and atrial fibrillation with rapid ventricular reaction that the drug cannot control within three months prior to screening
* Severe renal insufficiency, defined as estimated glomerular filtration rate\<30ml/min/1.73m2
* Active liver disease or liver dysfunction, whether it is on the patient's medical record or defined as an increase in alanine aminotransferase or aspartate aminotransferase more than 3 times above the upper limit of normal
* Records on statin or rosuvastatin (any dose) intolerance or other statin intolerance
* Known allergies to contrast agents, heparin, aspirin, ticagrelor or clopidogrel
* Known allergies to the supplements required for the use of the drug
* Patients who have been treated with evolocumab or other PCSK9 inhibitors
* Received cholesterol ester transfer protein inhibitors treatment 12 months prior to screening
* Received systemic steroid or cyclosporine treatment in the past 3 months
* Known infections, hemorrhages, metabolic or endocrine disorders as determined by the researchers
* Patients who have been included in other studies
* Patients with active malignant tumor in need of treatment
* Women with fertility (age \<50 years, menstruation in the past 12 months), did not receive tubal ligation, oophorectomy or hysterectomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04100434
Study Brief:
Protocol Section:
NCT04100434