Using PCSK9 inhibitors to improve heart recovery after a heart attack
Official title: Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium
Run by Shanghai Tong Ren Hospital · NCT04731155 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Shanghai Tong Ren Hospital Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Status | Recruiting |
| Started | April 12, 2021 |
| Main results expected | October 2025 |
| Study ends | October 2025 |
| Registry record updated | May 21, 2025 |
| Trial ID | NCT04731155 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Tongren Hospital, Shanghai
Shanghai, Shanghai Municipality, China Recruiting -
Shanghai tenth people's hospital
Shanghai, China Recruiting
Study contacts
- Study coordinator: Lei Hou, Doctor
- Email: Dr_houlei@163.com
- Phone: 13564868096
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.