- Question
- To determine whether four weekly infusions of CSL112, a plasma-derived human apolipoprotein A1 that increases cholesterol efflux, reduce recurrent cardiovascular events after acute myocardial infarction.
- Design
- International, randomized, double-blind, placebo-controlled trial with 18219 patients (9112 in the CSL112 group and 9107 in the placebo group). The first infusion was given within 5 days of first medical contact for the infarction.
- Population
- Patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors.
- Intervention
- Four weekly infusions of 6 g of CSL112.
- Control
- Four weekly infusions of matching placebo.
- Primary outcome
- Composite of myocardial infarction, stroke, or death from cardiovascular causes from randomization through 90 days of follow-up.
- Results
- A primary end-point event occurred in 439 patients (4.8%) with CSL112 and 472 (5.2%) with placebo (HR 0.93; 95% CI, 0.81 to 1.05; P = 0.24). There were also no significant differences at 180 days (HR 0.91; 95% CI, 0.81 to 1.01) or 365 days (HR 0.93; 95% CI, 0.85 to 1.02).
- Safety
- The percentage of patients with adverse events was similar between groups, although more hypersensitivity events were reported with CSL112.
- Conclusion
- Among patients with acute myocardial infarction, multivessel disease, and additional risk factors, CSL112 did not lower the risk of myocardial infarction, stroke, or cardiovascular death at 90 days compared with placebo.
- Why it matters
- This large phase 3 trial tested the strategy of boosting cholesterol efflux with apoA1 infusions after an infarction, and its neutral result does not support its use in clinical practice.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026