Effect of PCSK9 monoclonal antibody on serum lipids and cardiovascular events in patients with ACS before and after PCI: a single-center, prospective, randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200057508

Enrollment

Unknown

Registered

2022-03-14

Start date

2022-03-01

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

Acute Coronary Syndrome

Interventions

Group 1:Irolumab 140mg was administered 1-3 days before PCI, followed by irolumab 140mg/2w for 6 months

Group 2:Irolumab 140mg was administered 2 weeks after PCI, followed by irolumab 140mg/2w for 6 months

Group 3:Use the maximum tolerated dose of statins

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Confirm the diagnosis of acute coronary syndrome and coronary intervention is required; 3. Diagnostic criteria for acute coronary syndrome: (1) Angina pectoris or chest pain in resting state/light activity state >30 min; (2) The ECG indicated AMI (ST segment elevation >= 0.1mV or ST segment depression >= 0.1mV in adjacent leads); (3) Abnormal markers of myocardial injury [myoglobin (Myo), troponin I (cTnI) or creatine kinase isoenzyme (CKMB)]. Myo reference value 70%; 4. Sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe autoimmune diseases or malignant tumors; 2. Patients with severe liver, kidney, brain and lung dysfunction; 3. Patients with hyperthyroidism or hypothyroidism; 4. Patients with history of chronic heart failure or cardiomyopathy; 5. Patients allergic to statins and PCSK9 inhibitors; 6. Received PCSK9 inhibitor treatment in the last three months; 7. Life expectancy of patients <=12 months; 8. The investigator judged that the patient was not suitable to participate in this study for other reasons; 9. The investigator judged that the patient had poor compliance and could not complete the study as required; 10. Patients who are participating in other clinical trials (except for other patients in this program) and have not met the primary study endpoint time limit.

Design outcomes

Primary

Measure	Time frame
the change in lipid parameters;major cardiovascular adverse events;	—

Secondary

Measure	Time frame
secondary cardiovascular adverse events;CK-MB;cTnI;pro-BNP;ejection fraction;ST segment decline rate of ECG;inflammatory factor levels;PCSK9;	—

Countries

China

Contacts

Public ContactLi Yan

307712565@qq.com+86 13892890227

Outcome results

None listed

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