Evaluating the effect of Evolocumab on chronic total occlusions

Effect of Evolocumab on Chronic Total Occlusions After Successful Percutaneous Coronary Intervention (EVOLO-CTO)

This study is testing if adding the drug Evolocumab to regular cholesterol treatment can help people with blocked arteries feel better and avoid heart problems after a procedure to open those blockages.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05623995 on ClinicalTrials.gov

What this trial studies

This study aims to assess the impact of the PCSK9 inhibitor Evolocumab, when added to standard statin therapy, on target lesion failure and the progression of arteriosclerosis in patients with chronic total occlusions undergoing successful percutaneous coronary intervention. Chronic total occlusions are associated with a higher risk of major adverse cardiovascular events, and the study will utilize intravascular ultrasound imaging to monitor changes over a 48-week period. The goal is to determine whether this novel treatment approach can improve outcomes for patients with this condition.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stable angina or myocardial ischemia due to a chronic total occlusion scheduled for percutaneous coronary intervention.

Not a fit: Patients with recent acute myocardial infarction, severe chronic kidney disease, or known allergies to study medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of restenosis and improve cardiovascular outcomes for patients with chronic total occlusions.

How similar studies have performed: While the use of PCSK9 inhibitors is established in other cardiovascular contexts, this specific application in chronic total occlusions is novel and has not been extensively tested.

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.

Where this trial is running

Beijing, Beijing

• Beijing Anzhen Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Lin Zhao, MD — Beijing Anzhen Hospital
• Study coordinator: Xu Wang, MD

Conditions In-stent Restenosis; Major Adverse Cardiovascular Events; Chronic total occlusion; Restenosis