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

NCT05623995 | Unknown Phase 4 DMC

• 1 other identifier: 2022-22
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

In-stent Restenosis; Major Adverse Cardiovascular Events

Keywords

Chronic total occlusion; Restenosis

Outcome Measures

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.

  12 months

Secondary Outcomes (4)

• Rate of Target Lesion Failure (TLF)

  12 months

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

  12 months

• Ischemia

  12 months

• Change in left ventricular systolic function assessed with CMR

  12 months

Study Arms (2)

Treatment arm

EXPERIMENTAL

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

Drug: PCSK9 inhibitor

Control arm

ACTIVE COMPARATOR

Patients will continue to taking guideline recommended statin therapy.

Drug: Statin

Interventions

PCSK9 inhibitor DRUG

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

Also known as: Evolocumab

Treatment arm

Statin DRUG

Guideline recommended statin therapy.

Also known as: Hydroxymethylglutaryl-Coenzyme A Reductase inhibitor

Control arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lin Zhao: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Interventions

evolocumab; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Lin Zhao, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Wang, MD

CONTACT

+8615311765609; huaianwangxu@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 21, 2022
• Study Start: December 15, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)