Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PCSK9 inhibitor （Alirocumab）plus standard medications, standard medications.
- Who it may be relevant to
- Registry conditions: Early PCSK9 Inhibitor on Ventricular Remodling. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium
Overview
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
- Drug 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 - Drug standard medications
standard medications was giving to subjects according guidelines
Primary outcome measures
- myocardial salvage index measured by MRI [Time frame: one week after PPCI]
- myocardial salvage index measured by MRI [Time frame: six months after PPCI]
- eject fraction measured by MRI [Time frame: one week after PPCI]
- eject fraction measured by MRI [Time frame: six month after PPCI]
Secondary outcome measures (4)
- the change of serum level of TnI/T [Time frame: 0,6 ,12,18 , 24 ,30,and 36 hours after PPCI]
- LDL -C control rate [Time frame: the first month after PPCI]
- the serum lever of hsCRP [Time frame: Baseline (before PPCI)]
- the serum lever of hsCRP [Time frame: one week after PPCI]
Eligibility criteria
Inclusion criteria
- Subject must be at least 18 years of age and less than 80 years old
- Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for AMI and LAD should be the only culprit vessel.
- Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure
Exclusion criteria
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- Known hypersensitivity or contraindication to study medications
- Plan to receive revascularization in next six month.
- Have received revascularization before.
- Subjects with life expectation less than one year.
- Subjects with active malignant tumor
- subjects with severe liver or renal dysfunction（ALT >5倍ULA，eGFR<15ml/min/1.73mm2）
- Other conditions which the investigators think not applicable to the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Tongren Hospital, Shanghai — Shanghai
- Shanghai tenth people's hospital — Shanghai
Identifiers
NCT: NCT04731155 · 2021HL