Using PCSK9 inhibitors to improve heart recovery after a heart attack

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium

This study is testing if giving a new heart medication called Alirocumab right after a heart attack can help patients recover better and prevent further heart damage.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Tong Ren Hospital (Academic / other)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT04731155 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of administering a PCSK9 inhibitor early to patients who have experienced an acute myocardial infarction (AMI) to see if it can reduce ventricular remodeling following primary percutaneous coronary intervention (PPCI). A total of twenty participants will be randomly assigned to either a control group receiving standard AMI therapy or an experimental group receiving the PCSK9 inhibitor, Alirocumab, in addition to standard medications. The study will evaluate outcomes such as myocardial salvage index, TnI peaking time, and LDL control rates six months after the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have undergone successful PPCI for AMI with the left anterior descending artery as the only culprit vessel.

Not a fit: Patients with contraindications to the study medications, severe liver or renal dysfunction, or those with a life expectancy of less than one year may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved heart recovery and reduced complications for patients after a heart attack.

How similar studies have performed: While the use of PCSK9 inhibitors is established in cholesterol management, this specific application in the context of early intervention post-AMI is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Tongren Hospital, Shanghai — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai tenth people's hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Lei Hou, Doctor

Conditions Early PCSK9 Inhibitor on Ventricular Remodling