Early treatment with PCSK9 inhibitors after heart attack

Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial

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
• Enrollment: 160 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Tong Ren Hospital (Academic / other)
• Drugs / interventions: alirocumab
• Locations: 5 sites (Shanghai, Shanghai Municipality and 4 other locations)
• Trial ID: NCT05292404 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Shanghai, Shanghai Municipality and 4 other locations

• 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

Conditions Acute Myocardial Infarction