Phase 2
N=60
Evolocumab in Acute Coronary Syndrome
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03515304 ↗Enrolled (actual)
60
Serious AEs
13.3%
Results posted
Nov 2025
Primary outcome: Primary: Percent Change in LDL-Cholesterol — -68.78; -27.58 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Evolocumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in LDL-Cholesterol |
-68.78; -27.58 | — |
| PRIMARY Change From Baseline in Target to Background Ratio Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Scans |
-26.7; -10.4 | — |
| SECONDARY Left Ventricular Volume as Assessed by Echocardiography |
67.80; 59.45; 54.57; 55.63; 62.53; 51.12 | — |
| SECONDARY Ejection Fraction as Assessed by Echocardiography |
44.28; 49.04; 51.35; 51.90; 50.04; 54.39 | — |
| SECONDARY Plasma Proprotein Convertase Subtilisin Kexin-9 (PCSK9) Levels (ng/ml) |
244.2; 257.3; NA; 261.9; 215.4; 264.5 | — |
| SECONDARY PET-FDG Assessed Vascular Inflammation as Assessed by Standardized Uptake Value (SUV) |
3.134705882; 3.708333333 | 0.2497 |
| SECONDARY High Sensitivity C-reactive Protein (Hs-CRP) Serum Levels |
29.59; 35.48; 15.18; 7.609; 5.174; 3.121 | — |
| SECONDARY Change in Serum Levels of Interleukin 6 |
34.31; 23.08; 8.310; 5.962; 6.941; 2.200 | — |
| SECONDARY Serum Levels of Interleukin 10 |
10.61; 7.948; 9.370; 5.204; 9.291; 5.243 | — |
Summary
Vascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome (ACS) patients, are closely correlated to LDL-C levels, and are associated with these adverse consequences in the post-ACS patient population. Serum proprotein convertase subtilisin/kerin type 9 (PCSK9) levels are also increased in ACS, may raise LDL-C, and the investigators' pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation. The addition of the PCSK9 antibody evolocumab, currently approved to lower LDL-C in certain patient populations, to current medical therapies would appear to be of particular benefit in an important subset of ACS patients, those with non-ST elevation myocardial infarction (NSTEMI) by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.
Eligibility Criteria
Inclusion Criteria
- Non ST segment elevation myocardial infarction
- Troponin I >/ 5.0 ng/dL
- Permission of attending physician
Exclusion Criteria
- ST elevation myocardial infarction
- Patients requiring invasive hemodynamic support
- Scheduled for cardiac surgery
- Current or prior treatment with a PCSK9 antibody
- Current participation in an intervention clinical trial
- Female of childbearing potential who has not used acceptable method(s) of birth control for at least one month prior to screening
- Contraindication to statin therapy
- Subject likely not able to complete protocol related visits or procedures
- Latex allergy
- History of hypersensitivity to any monoclonal antibody
Data sourced from ClinicalTrials.gov (NCT03515304). 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.