Phase 3
N=18,226
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03473223 ↗Enrolled (actual)
18,226
Serious AEs
17.0%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke) — 439; 472 Participants — p=0.121
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Apolipoprotein A-I [human] (apoA-I) (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CSL Behring
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke) |
439; 472 | 0.121 |
| SECONDARY Total Number of Hospitalizations for Coronary, Cerebral, and Peripheral Ischemia |
433; 442; 367; 376; 39; 36 | 0.341 |
| SECONDARY Number of Participants With First Occurrence of CV Death, MI, or Stroke |
885; 944 | 0.069 |
| SECONDARY Number of Participants With First Occurrence of CV Death, MI, or Stroke |
885; 944 | 0.069 |
| SECONDARY Number of Participants With Occurrence of CV Death |
107; 128 | 0.074 |
| SECONDARY Number of Participants With First Occurrence of MI |
312; 342 | 0.113 |
| SECONDARY Number of Participants With First Occurrence of Stroke |
57; 49 | 0.767 |
| SECONDARY Number of Participants With First Occurrence of CV Death, Type 1 MI or Stroke |
272; 308; 400; 444; 594; 639 | — |
| SECONDARY Number of Participants With Occurrence of All-cause Death |
341; 345 | — |
| SECONDARY Number of Participants With Adverse Events |
3938; 3927 | — |
| SECONDARY Percentage of Participants With Adverse Events |
43.7; 43.5 | — |
| SECONDARY Number of Participants With Treatment-related Adverse Events |
350; 304 | — |
| SECONDARY Percentage of Participants With Treatment-related Adverse Events |
3.9; 3.4 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
1514; 1557 | — |
| SECONDARY Percentage of Participants With SAEs |
16.8; 17.2 | — |
| SECONDARY Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments |
0; 1; 365; 393; 0; 1 | — |
| SECONDARY Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments |
0.0; 0.0; 5.3; 5.8; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Hematology Parameters |
0.004; 0.005; 0.045; 0.047; -1.024; -0.969 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Hematocrit |
-0.003; -0.004 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Hemoglobin |
-1.1; -1.3 | — |
| SECONDARY Change From Baseline in Hepatic Parameters |
-5.5; -6.5; 3.2; 4.5; -21.2; -20.7 | — |
| SECONDARY Change From Baseline in Hepatic Parameter: Bilirubin |
-2.6; -1.9; -0.4; -0.3; -2.0; -1.4 | — |
| SECONDARY Change From Baseline in Renal Parameter: Serum Creatinine |
2.4; 2.1 | — |
| SECONDARY Change From Baseline in Renal Parameter: eGFR |
-1.3; -1.2 | — |
| SECONDARY Change From Baseline in Renal Parameter: Blood Urea Nitrogen |
0.0; 0.0 | — |
Summary
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.
Eligibility Criteria
Inclusion Criteria
- Male or female least 18 years of age
- Evidence of myocardial necrosis, consistent with type I (spontaneous) MI
- No suspicion of acute kidney injury
- Evidence of multivessel coronary artery disease
- Presence of established cardiovascular risk factor(s):
- Diabetes mellitus on pharmacotherapy OR
- 2 or more of the following: age ≥ 65 years, prior history of MI, peripheral arterial disease
Exclusion Criteria
- Ongoing hemodynamic instability
- Evidence of hepatobiliary disease
- Evidence of severe chronic kidney disease
- Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the index MI
- Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin
Data sourced from ClinicalTrials.gov (NCT03473223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.