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The treatment of PCSK9 inhibitor Evolocumab in Patients with Non-ST-elevation Acute Coronary Syndrome Complicated with Multivessel Coronary Disease

Safety and Efficacy of PCSK9 Inhibitors in Patients with non-ST-elevation Acute Coronary Syndrome complicated with Multivessel Coronary Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066675
Enrollment
Unknown
Registered
2022-12-13
Start date
2022-12-20
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Non-ST-elevation Acute Coronary Syndrome

Interventions

experimental group:Resuvastatin 10mg/day+ilozumab 140mg subcutaneous injection once every two weeks
control group:Resuvastatin 10mg/day

Sponsors

the first affiliated hospital of USTC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1)age =18 years at screening (2)NST-ACS,with at least one coronary segment (culprit lesion) requiring PCI (3)LDL-C =70 mg/dL assessed prior to, or during PCI in patients who have been receiving any stable statin regimen within = 4 weeks prior to enrollment; OR LDL-C =130 mg/dL in patients who are statin-na?ve or have not been on stable statin regimen for = 4 weeks prior to enrollment (4)Angiographic evidence of 50% -75% reduction in lumen diameter by angiographic visual estimation (5)Target vessel may not be a bypass (saphenous vein or arterial) graft or a bypassed native vessel (6)Target vessel must not have undergone previous PCI within the target segment (7)Hemodynamic stability allowing the repetitive administration of Nitroglycerine (8)Willingness of patient to undergo follow-up intracoronary imaging

Exclusion criteria

Exclusion criteria: (1)Left-main disease, defined as =50% reduction in lumen diameter of the left main coronary artery by angiographic visual estimation (2)Estimate =75% reduction in lumen diameter of Non-culprit vessel by angiographic visual estimation (3)History of coronary artery bypass surgery or unstable clinical status (hemodynamic instability) (4)Severe renal dysfunction, defined by estimated glomerular filtration rate <30 ml/min/1.73m2 (5)Active liver disease or hepatic dysfunction (6)Known intolerance to rosuvastatin OR known statin intolerance (7)Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel (8)Patients who previously received PCSK9 inhibitor (9)Patient who received cholesterol ester transfer protein inhibitors in the past 12 months prior to screening (10)Treatment with systemic steroids or systemic cyclosporine in the past 3 months (11)Active infection or major hematologic, metabolic, or endocrine dysfunction (12)Pregnant or lactating women (13)Estimated life expectancy less than 1 year (14)Unwilling to finish the follow-up.

Design outcomes

Primary

MeasureTime frame
Change in minimal fibrous cap thickness(FCT);

Secondary

MeasureTime frame
MACCE;Change in lipid levels;Absolute change in the average of minimum FCT for all images;;Absolute change in maximum lipid arc throughout the segment;Absolute change in maximum lipid length throughout the segment;macrophage grading;

Countries

China

Contacts

Public ContactWu jiawei

the first affliated hospital of USTC

Wjwei626@163.com13856997469

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026