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Clinical Trials in China / NCT04731155
Recruiting Phase 4

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

NCT04731155 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Tong Ren Hospital
Phase
Phase 4
Started
2021-04-12
Last updated
2025-05-21

Condition(s) studied

Early PCSK9 Inhibitor on Ventricular Remodling

Investigational drug(s) / intervention(s)

PCSK9 inhibitor (Alirocumab)plus standard medicationsstandard medications

PCSK9 inhibitor (Alirocumab)plus standard medications: PCSK9 inhibitor(Alirocumab) was giving to subjects before PPCI and continued twice a month until 3 month after AMI

standard medications: standard medications was giving to subjects according guidelines

Study summary

This is a prospect, multi-center, random study to investigate whether early offering PCSK9 inhibitor to acute myocardium infarction(AMI) can alleviate ventricular remodeling after primary percutaneous intervention(PPCI). Totally,twenty acute myocardium infarction subjects will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy for AMI including PPCI. The experiment group will receive first PCSK9 inhibitor before PPCI, then twice a month until 3 months later. Six month after AMI, Myocardial salvage index will be used to evaluate ventricular remodeling. TnI peaking time and LDL control rates also will be recorded and compared.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Subject must be at least 18 years of age and less than 80 years old 2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for AMI and LAD should be the only culprit vessel. 3. Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure Exclusion Criteria: 1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study 2. Known hypersensitivity or contraindication to study medications 3. Plan to receive revascularization in next six month. 4. Have received revascularization before. 5. Subjects with life expectation less than one year. 6. Subjects with active malignant tumor 7. subjects with severe liver or renal dysfunction(ALT \>5倍ULA,eGFR\<15ml/min/1.73mm2) 8. Other conditions which the investigators think not applicable to the study.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Tongren Hospital, Shanghai Shanghai Shanghai Municipality Recruiting
Shanghai tenth people's hospital Shanghai China Recruiting

More Shanghai Tong Ren Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04731155 on ClinicalTrials.gov ↗ ← All trials in China