Optimal LDL-C Target in High-risk Patients After PCI

Launched by XIJING HOSPITAL · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether lowering a specific type of cholesterol called low-density lipoprotein cholesterol (LDL-C) to very low levels (less than 0.8 mmol/L) can help reduce serious health problems in patients who are at high risk for heart issues after a procedure called percutaneous coronary intervention (PCI). This procedure is often done to open blocked arteries in patients with heart conditions. The trial aims to see if keeping LDL-C at these lower levels can further decrease the chances of heart attacks or strokes compared to the current recommendation of 0.8-1.4 mmol/L.

To participate in this trial, patients need to be between 65 and 74 years old and have undergone PCI due to serious heart problems. They must also meet specific criteria indicating they are at extremely high risk for heart disease, such as having had a heart attack or stroke in the past, having diabetes, or other significant health issues. Participants will receive treatment and will be followed over time to see how well the lower cholesterol target works. It's important to note that the trial is not yet recruiting participants, and there are certain health conditions that could prevent someone from joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients underwent percutaneous coronary intervention due to acute or chronic coronary syndrome
• • 2. Patients with ASCVD at extremely high risk
• • 3. Patients who are able to complete the follow-up and compliant with the allocated treatment
• * ASCVD at extremely high risk is defined as fulfilling at least TWO of the following criteria:
• • 1. PCI for acute myocardial infarction (AMI, including STEMI or NSTEMI)
• • 2. Previous AMI, previous stroke, or previous intervention or surgery for peripheral vascular disease
• • 3. Experienced cardiovascular event(s) with LDL-C≤1.8mmol/L
• • 4. LDL-C≥4.9mmol/L
• • 5. Diabetes
• • 6. CKD (eGFR \< 60 ml/min/1.73m2)
• • 7. Current smoking
• • 8. Recurrent cardio/cerebrovascular events
• • 9. History of premature ASCVD (\< 55 male, \< 65 female)
• • 10. Complex PCI (fulfilling at least one of the following criteria: multivessel disease; in-stent restenosis; ≥ 3 stents implanted; total stent length ≥ 60 mm; bifurcation; left main disease; target lesions allocated in bypass graft; chronic total occlusion (≥ 3 months of occlusion))
• Exclusion Criteria:
• • 1. Age less than 18 years;
• • 2. Unable to give informed consent or currently participating in other trials;
• • 3. Patient who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to randomization in women of child-bearing potential according to local practice), or plans to become pregnant during treatment;
• • 4. Concurrent medical condition with a life expectancy of less than 3 years;
• • 5. Hemodynamic unstable;
• • 6. Active liver disease or hepatic dysfunction (persistent unexplained ALT/AST elevations (≥ 3 × ULN)), patients with a transient increase ALT/AST due to the acute MI may be enrolled;
• • 7. Unable to reach the LDL-C target by known intolerance or contradiction of lipid control medications;
• • 8. LDL-C ≤ 1.4 mmol/L at baseline without any lipid control medication lowering LDL-C;
• • 9. Known active infection or critical hematologic/endocrine dysfunction.