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Preliminary observational study of PCSK9 inhibitor Evolocumab to prevent restenosis after successful interventional treatment of chronic coronary occlusive disease

Preliminary observational study of PCSK9 inhibitor Evolocumab to prevent restenosis after successful interventional treatment of chronic coronary occlusive disease

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076771
Enrollment
Unknown
Registered
2023-10-18
Start date
2021-10-11
Completion date
Unknown
Last updated
2023-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic total occlusion of coronary artery

Interventions

Statin group:N/A
Combined lipid-lowering group of statin and PCSK9 inhibitor group:N/A

Sponsors

Fuwai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) De novo CTO lesions of the main epicardial coronary artery (including the left anterior descending branch, the left circumflex branch, and the right coronary artery); (2) Successfully opened the CTO lesion and implanted the stent in any way; (3) Coronary blood flow reached TIMI grade 3 after stent implantation; (4) Aged =18 years old.

Exclusion criteria

Exclusion criteria: (1) CTO-PCI was unsuccessful; (2) TIMI blood flow in the distal coronary artery after CTO-PCI < grade 3; (3) Bifurcation lesions implanted with double stents; (4) CTO-PCI lesions of bridge vessels; (5) In-stent occlusion lesions; (6) Left ventricular ejection fraction <40%; (7) Acute myocardial infarction; (8) Patients who cannot use statins and/or PCSK9 inhibitors; (9) Patients who cannot use antiplatelet drugs; (10) Currently receiving PCSK9 inhibitor therapy; (11) Inappropriate for OCT examination; (12) Familial hypercholesterolemia; (13) Type I diabetes; (14) Previous cerebral hemorrhage; (15) Malignant tumors undergoing treatment; (16) Breastfeeding/pregnant women or women of childbearing age who do not take effective contraceptive measures; (17) No informed consent was signed.

Design outcomes

Primary

MeasureTime frame
In-stent neointimal loading percentage;

Secondary

MeasureTime frame
Stenosis degree of maximum lumen area;In-stent restenosis;Blood lipids;Adverse event;

Countries

China

Contacts

Public ContactZhang Hongliang

Fuwai Hospital

13810694497@163.com+86 138 1069 4497

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026