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RecruitingNCT05623995Updated Nov 13, 2023

Effect of Evolocumab on Chronic Total Occlusions (EVOLO-CTO)

A Phase 4 interventional study of PCSK9 inhibitor and Statin in In-stent Restenosis and Major Adverse Cardiovascular Events, sponsored by Lin Zhao. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Lin Zhao · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 9 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 target lesion failure (TLF) and arteriosclerosis progression in patients with chronic total occlusions (CTOs) undergoing successful percutaneous coronary intervention (PCI).

Read the detailed description

Chronic total occlusions (CTOs) are found in 15-25% of patients with stable angina pectoris. The presence of a CTO indicates unfavorable prognosis, with higher rate of major adverse cardiovascular events. Statins are frequently used after PCI in order to lower LDL cholesterol levels and reduce the chances of coronary artery obstruction recurring. Despite this preventive measure, high risk for restenosis and re-occlusion was observed a significant proportion of patients with CTOs undergoing PCI.

Proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors represent a novel class of lipid-lowering drugs leading to rapid, profound, and consistent reductions in LDL-C levels. The effect of PCSK9 inhibitor in patients with CTO, after a recent PCI is not known.

In this study the investigators want to evaluate the effect of the PCSK9 inhibitor on neointimal hyperplasia and target lesion failure (TLF) in patients with CTOs receiving regular statin treatment. A serial of intravascular ultrasound imaging study will be performed to determine the arteriosclerosis progression at 48 weeks.

02

Conditions studied

  • In-stent Restenosis
  • Major Adverse Cardiovascular Events

Keywords

  • Chronic total occlusion
  • Restenosis
03

In context

Lead sponsor

Lin Zhao is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Treatment arm

    Participants will receive PCSK9 inhibitors added to guideline recommended statin therapy.

    Drug: PCSK9 inhibitor

  • Active comparator
    Control arm

    Patients will continue to taking guideline recommended statin therapy.

    Drug: Statin

Interventions

  • DrugPCSK9 inhibitor

    Evolocumab per every two weeks, starting at day 1 and up to week 48, added to guideline recommended statin therapy..

    Also known as: Evolocumab

  • DrugStatin

    Guideline recommended statin therapy.

    Also known as: Hydroxymethylglutaryl-Coenzyme A Reductase inhibitor

06

What researchers measure

Primary outcomes

  1. Change in percent plaque volume and plaque burden.

    Change in percent plaque volume and plaque burden by intravascular ultrasound (IVUS) between PCSK9 inhibitors group and control group.

    Time frame: 12 months

Secondary outcomes

  1. Rate of Target Lesion Failure (TLF)

    TLF is defined as a composite of: all cardiac death, target vessel myocardial infarction (SCAI definition), and clinically driven target lesion revascularization (TLR).

    Time frame: 12 months

  2. Neointimal volume with intravascular ultrasound (IVUS) (mm3 per 1mm)

    Comparison of neointima volume by IVUS between PCSK9 inhibitors group and control group.

    Time frame: 12 months

  3. Ischemia

    Ischemic burden assessed with CMR from baseline to 3 and 12 months follow-up

    Time frame: 12 months

  4. Change in left ventricular systolic function assessed with CMR

    The left ventricular ejection fraction assessed with CMR from baseline to 3 and 12 months follow up

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Beijing Anzhen Hospital
    Beijing, Beijing 100029, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05623995
Lead sponsor
Lin Zhao
Responsible party
Lin Zhao (Principal Investigator, Beijing Anzhen Hospital) — Sponsor-investigator
First posted
Nov 21, 2022
Start date
Dec 15, 2022
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Nov 13, 2023

Study contacts

Xu Wang, MD
Contact
huaianwangxu@126.com
+8615311765609
Lin Zhao, MD
principal investigator · Beijing Anzhen Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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