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 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT05623995
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age with written informed consent
* Presence of a CTO in native coronary artery.
* Stable angina or myocardial ischemia in a territory supplied by CTO
* CTO located in segments 1-3 (RCA), 6-7 (LAD), 11-12 (LCx)
* Target artery ≥2.5mm
* Scheduled to undergo percutaneous coronary intervention (PCI)
* LDL-C ≥70 mg/dL (≥1.8 mmol/L) in patients who have been on any stable statin regimen for ≥ 4 weeks prior to enrollment; or LDL-C ≥125 mg/dL (≥3.2 mmol/L) in patients who are statin-naïve or have not been receiving stable statin regimen for ≥ 4 weeks prior to enrollment
Exclusion Criteria:
* Acute myocardial infarction within 1 month
* Known severe chronic kidney disease (estimated Glomerular Filtration Rate \[eGFR\] \<60 mL/min/1.73m2 or serum creatinine level \>2.5 mg/dL);
* History of allergy to iodine contrast agents
* Allergy to PCSK9 inhibitors or any other ingredients contained in study drug
* Pregnancy or breastfeeding
* Persistent or permanent atrial fibrillation
* Patients with history of coronary artery bypass graft
* Inability or unwilling to provide informed consent
* Malignant neoplasms or Major illness with life expectancy \<1 year
* Planned coronary revascularization or major non-cardiac surgery 12 months after intervention
* Patients previously treated with PCSK9 inhibitors.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05623995
Study Brief:
Protocol Section:
NCT05623995