Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Tong Ren Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PCSK9 inhibitor （Alirocumab）plus standard medications
DrugPCSK9 inhibitor（Alirocumab） was giving to subjects before PPCI and continued twice a month until 3 month after AMI
standard medications
Drugstandard medications was giving to subjects according guidelines
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: standard groupActive comparator 1 intervention
Group B: experiment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
myocardial salvage index measured by MRI
Time frame
one week after PPCI2
myocardial salvage index measured by MRI
Time frame
six months after PPCI3
eject fraction measured by MRI
Time frame
one week after PPCI4
eject fraction measured by MRI
Time frame
six month after PPCISecondary outcomes
1
the change of serum level of TnI/T
Time frame
0,6 ,12,18 , 24 ,30,and 36 hours after PPCI2
LDL -C control rate
Time frame
the first month after PPCI3
the serum lever of hsCRP
Time frame
Baseline (before PPCI)4
the serum lever of hsCRP
Time frame
one week after PPCISponsors and contacts
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Source ClinicalTrials.gov