Early PCSK9 Inhibitor on Ventricular Remodling
Conditions
Brief 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.
Interventions
DRUGPCSK9 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 was giving to subjects according guidelines
Sponsors
Shanghai Tong Ren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| myocardial salvage index measured by MRI | one week after PPCI |
| eject fraction measured by MRI | one week after PPCI |
Secondary
| Measure | Time frame |
|---|---|
| the change of serum level of TnI/T | 0,6 ,12,18 , 24 ,30,and 36 hours after PPCI |
| LDL -C control rate | the first month after PPCI |
| the serum lever of hsCRP | Baseline (before PPCI) |
Countries
China
Contacts
Primary ContactLei Hou, Doctor
Outcome results
None listed