New treatment option for Acute Myocardial Infarction (AMI)
Official title Very Early PCSK9 Inhibition for Acute Myocardial Infarction
ClinicalTrials.gov ID: NCT07208006
What this study is testing
What is Standard Lipid-Lowering Therapy?
Standard Lipid-Lowering Therapy is an investigational medicine, being studied as a potential treatment for acute myocardial infarction (ami).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality, particularly in patients with multivessel coronary artery disease. Although primary percutaneous coronary intervention (PCI) has significantly improved short-term outcomes, these patients remain at high risk of recurrent cardiovascular events due to vulnerable non-culprit plaques.
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Age ≥18 years.
- Acute myocardial infarction (AMI) onset within 30 days (first hospitalization with a confirmed diagnosis of STEMI or NSTEMI).
- Multivessel coronary artery disease; successful percutaneous coronary intervention (PCI) of the culprit lesion in the infarct-related artery (IRA)...
- At least one angiographically assessed diameter stenosis ≥50% in a non-infarct-related artery (non-IRA) with a reference vessel diameter ≥2.5 mm.
- Able to understand and willing to provide written informed consent, comply with prescribed medical therapy, and complete the required follow-up.
You likely can't join if
- Cardiogenic shock or severe heart failure (Killip class IV).
- Serum creatinine \>150 μmol/L or glomerular filtration rate (GFR) \<45 mL/min/1.73 m² calculated by the Cockcroft-Gault equation.
- Known or suspected infective endocarditis or active systemic infection.
- Clinically significant coagulation abnormalities, or anticipated inability to tolerate long-term antiplatelet therapy.
- Pregnant or breastfeeding women, women planning pregnancy within 1 year, or those unwilling to use effective contraception.
- Expected survival \<1 year.
See the full eligibility criteria
- Age ≥18 years.
- Acute myocardial infarction (AMI) onset within 30 days (first hospitalization with a confirmed diagnosis of STEMI or NSTEMI).
- Multivessel coronary artery disease; successful percutaneous coronary intervention (PCI) of the culprit lesion in the infarct-related artery (IRA), including stent implantation and/or balloon angioplasty and/or thrombus...
- At least one angiographically assessed diameter stenosis ≥50% in a non-infarct-related artery (non-IRA) with a reference vessel diameter ≥2.5 mm.
- Able to understand and willing to provide written informed consent, comply with prescribed medical therapy, and complete the required follow-up.
- Cardiogenic shock or severe heart failure (Killip class IV).
- Serum creatinine \>150 μmol/L or glomerular filtration rate (GFR) \<45 mL/min/1.73 m² calculated by the Cockcroft-Gault equation.
- Known or suspected infective endocarditis or active systemic infection.
- Clinically significant coagulation abnormalities, or anticipated inability to tolerate long-term antiplatelet therapy.
- Pregnant or breastfeeding women, women planning pregnancy within 1 year, or those unwilling to use effective contraception.
- Expected survival \<1 year.
- Allergy to iodinated contrast media.
- Prior coronary artery bypass grafting (CABG).
- Participation in another clinical trial within 3 months before enrollment, or current participation in another drug/device clinical trial without having reached its primary endpoint.
- Coronary angiography-based exclusion criteria: 10.1 Non-IRA lesion with visually estimated diameter stenosis \>90% and TIMI flow ≤2; 10.2 Complex coronary artery disease requiring CABG; 10.3 Angiography unable to...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.