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Recruiting
NCT05623995
Effect of Evolocumab on Chronic Total Occlusions (EVOLO-CTO)
Conditions: In-stent Restenosis, Major Adverse Cardiovascular Events
Sex: All
Ages: 18 Years – 80 Years
Phase: PHASE4
Enrollment: 200
Sponsor: Lin Zhao
Location: China
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).
Eligibility Criteria
Inclusion Criteria:≥ 18 years of age with written informed consentPresence of a CTO in native coronary artery.Stable angina or myocardial ischemia in a territory supplied by CTOCTO located in segments 1-3 (RCA), 6-7 (LAD), 11-12 (LCx)Target artery ≥2.5mmScheduled 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 enrollmentExclusion Criteria:Acute myocardial infarction within 1 monthKnown 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 agentsAllergy to PCSK9 inhibitors or any other ingredients contained in study drugPregnancy or breastfeedingPersistent or permanent atrial fibrillationPatients with history of coronary artery bypass graftInability or unwilling to provide informed consentMalignant neoplasms or Major illness with life expectancy <1 yearPlanned coronary revascularization or major non-cardiac surgery 12 months after interventionPatients previously treated with PCSK9 inhibitors.
Source: ClinicalTrials.gov (NCT05623995). StuddyBuddy aggregates publicly available trial information.