Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

NCT ID: NCT04731155

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2025-10-31

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.

Conditions

Early PCSK9 Inhibitor on Ventricular Remodling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard group

Group Type: ACTIVE_COMPARATOR

standard medications

Intervention Type: DRUG

standard medications was giving to subjects according guidelines

experiment group

Group Type: EXPERIMENTAL

PCSK9 inhibitor （Alirocumab）plus standard medications

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

standard medications

standard medications was giving to subjects according guidelines

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Tong Ren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hou Lei

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tongren Hospital, Shanghai

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Shanghai tenth people's hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Hou, Doctor

Role: CONTACT

Dr_houlei@163.com

13564868096

Facility Contacts

Lei Hou, Doctor

Role: primary

Dr_houlei@163.com

13564868096

Yi Zhang

Role: primary

Other Identifiers

2021HL

Identifier Type: -

Identifier Source: org_study_id