Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

Early PCSK9 Inhibitor on Ventricular Remodling Clinical Trial

— PERFECT-AMI  

Official title:

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04731155
• Other study ID #: 2021HL
• Status: Recruiting
• Phase: Phase 4
• Start date: April 12, 2021
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Shanghai Tong Ren Hospital
• Contact: Lei Hou, Doctor
• Phone: 13564868096
• Email: Dr_houlei[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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?ULA,eGFR<15ml/min/1.73mm2)

8. Other conditions which the investigators think not applicable to the study.

Related Conditions & MeSH terms

• Early PCSK9 Inhibitor on Ventricular Remodling

Intervention

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
• standard medications
standard medications was giving to subjects according guidelines

Locations

Country	Name	City	State
China	Shanghai tenth people's hospital	Shanghai
China	Tongren Hospital, Shanghai	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Tong Ren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial salvage index measured by MRI		one week after PPCI
Primary	myocardial salvage index measured by MRI		six months after PPCI
Primary	eject fraction measured by MRI		one week after PPCI
Primary	eject fraction measured by MRI		six month after PPCI
Secondary	the change of serum level of TnI/T		0,6 ,12,18 , 24 ,30,and 36 hours after PPCI
Secondary	LDL -C control rate		the first month after PPCI
Secondary	the serum lever of hsCRP		Baseline (before PPCI)
Secondary	the serum lever of hsCRP		one week after PPCI