Early treatment with PCSK9 inhibitors after heart attack
Official title: Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial
Run by Shanghai Tong Ren Hospital · NCT05292404 · 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 than standard treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Shanghai Tong Ren Hospital Academic / other |
| Drugs / interventions | alirocumab |
| Locations | 5 sites (Shanghai, Shanghai Municipality and 4 other locations) |
| Status | Recruiting |
| Started | October 1, 2022 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT05292404 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 who have been diagnosed with STEMI and are scheduled for PPCI within 24 hours of symptom onset.
✕Probably not a fit
Patients with severe liver or kidney dysfunction, active malignancies, or those who have previously undergone revascularization 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 early treatment with the PCSK9 inhibitor alirocumab in patients who have experienced a STEMI and are undergoing PPCI. Participants are randomly assigned to receive either the PCSK9 inhibitor or conventional treatment, with the primary endpoint being the myocardial salvage index measured by cardiac MRI one week post-operation. Secondary endpoints include the assessment of ejection fraction at six months and various cardiac biomarkers at specified intervals. The study aims to determine if early intervention with PCSK9 inhibitors can improve heart recovery after a heart attack.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance heart recovery and reduce long-term complications for patients after a heart attack.
How similar studies have gone: While the use of PCSK9 inhibitors is established in other cardiovascular contexts, this specific approach following acute myocardial infarction is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The age is greater than 18 years old and less than or equal to 80 years old. 2. Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI . 3. Signed informed consent. Exclusion Criteria: 1. Patients who are allergic to PCSK9 inhibitors. 2. Multivessel disease planned for selective intervention within half a year. 3. Patients who have previously undergone revascularization. 4. Pregnant women or women who plan to become pregnant in the next 2 years. 5. Patients whose life expectancy is less than 1 year. 6. Severe liver or kidney dysfunction (ALT\>5 times ULA, eGFR\<15ml/min/1.73m2) 7. Known active malignant tumor diseases. 8. Patients considered by the investigator to be unsuitable to participate in this study.
Where it's running
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nineth people's hospital, School of Medicine, shanghai jiaotong university
Shanghai, Shanghai Municipality, China Recruiting -
Shanghai chest hospital
Shanghai, Shanghai Municipality, China Recruiting -
Shanghai tongren hospital
Shanghai, Shanghai Municipality, China Recruiting -
tenth people's hospital, tongji university, Shanghai
Shanghai, Shanghai Municipality, China Recruiting -
Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Lei Hou, doctor
- Email: Dr_houlei@163.com
- Phone: 86-13564868096
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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We will follow people who got one dose of Hearticellgram-AMI after a heart attack for up to 60 months to see if the treatment stays safe.
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This trial will test whether daily brief arm blood‑flow restriction after a recent heart attack can lower the chance of major heart and brain events over the following year for people treated for acute myocardial infarction.
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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.