Effect of PCSK9 Inhibitors on Chronic Total Occlusions

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors added to regular statin therapy on neointimal hyperplasia and target lesion failure (TLF) in patients with chronic total occlusions (CTOs) undergoing successful percutaneous coronary intervention (PCI).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lin Zhao
• Treatments: Evolocumab; Hydroxymethylglutaryl-CoA Reductase Inhibitors

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.