Status:
NOT_YET_RECRUITING
Very Early PCSK9 Inhibition for Acute Myocardial Infarction
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Acute Myocardial Infarction (AMI)
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality, particularly in patients with multivessel coronary artery disease. Although primary percutaneous coronary interventi...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Acute myocardial infarction (STEMI or NSTEMI) within 30 days of symptom onset.
- Successful percutaneous coronary intervention (PCI) of the culprit lesion (defined as residual stenosis \<30% with TIMI 3 flow and without major dissection or thrombus after stent implantation or balloon angioplasty).
- Presence of multivessel coronary artery disease, with at least one non-infarct-related artery (reference vessel diameter ≥2.5 mm) showing ≥50% diameter stenosis by visual estimation.
- Ability to understand the study requirements, provide written informed consent, and comply with medical therapy and follow-up visits.
Exclusion
- Cardiogenic shock or severe heart failure (Killip class IV).
- Serum creatinine \>150 μmol/L or estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m².
- Infective endocarditis or active systemic infection.
- Clinically significant coagulation disorders or inability to tolerate long-term dual antiplatelet therapy.
- Pregnant or breastfeeding women, or women planning pregnancy within 1 year or unwilling to use effective contraception.
- Life expectancy \<1 year due to non-cardiac comorbidities.
- Known allergy to iodinated contrast media.
- Previous coronary artery bypass grafting (CABG).
- Participation in another investigational drug or device clinical trial within the past 3 months, or currently participating without having reached the primary endpoint.
- Coronary angiography findings:
- 1 Non-infarct-related artery with \>90% stenosis and TIMI flow \<3. 10.2 Coronary anatomy requiring CABG as judged by the treating physician. 10.3 Inability to clearly identify culprit or non-culprit arteries due to overlapping, tortuosity, or poor angiographic quality.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
1518 Patients enrolled
Trial Details
Trial ID
NCT07208006
Start Date
January 1 2026
End Date
October 31 2028
Last Update
November 26 2025
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