Randomised controlled trial
Apolipoprotein A1 Infusions and Cardiovascular Outcomes after Acute Myocardial Infarction
- Randomised controlled trial
- international
- double-blind
- placebo-controlled
Authors' conclusion
Among patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors, four weekly infusions of CSL112 did not result in a lower risk of myocardial infarction, stroke, or death from cardiovascular causes than placebo through 90 days.
Study context
- Population
- Patients with acute MI, multivessel CAD and additional CV risk factors
- Participants
- 18,219 patients
- Comparison
- CSL112 infusions vs placebo
- CSL112n = 9,112
- Placebon = 9,107reference
- Primary endpoint
- Composite of:
- MI
- Stroke
- CV death
- Follow-up
- Randomisation through 90 days
Primary result
As reported in the abstract
90 days
Hazard ratio
0.93
95% CI 0.81–1.05
P = 0.24
Events by treatment group
CSL112 vs Placebo
HR 0.93 (95% CI 0.81–1.05); P = 0.24
Further findings
| Outcome | CSL112 | Placebo | HR (95% CI) | |
|---|---|---|---|---|
| Primary composite endpoint · 180 days | 6.9% | 7.6% | 0.91 (0.81–1.01) | |
| Primary composite endpoint · 365 days | 9.8% | 10.5% | 0.93 (0.85–1.02) | |
| 0.512Hazard ratio (log scale) |
Safety
Adverse events
- Percentage of patients with adverse events similar in the two groups
- Higher number of hypersensitivity events with CSL112
Original publication
Apolipoprotein A1 Infusions and Cardiovascular Outcomes after Acute Myocardial Infarction. N Engl J Med. Published 6 April 2024. doi:10.1056/nejmoa2400969
Summarised from the published abstract; every number is checked against it