Phase 2
N=100
Evolocumab in Patients With Acute MI
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04082442 ↗Enrolled (actual)
100
Serious AEs
8.0%
Results posted
Oct 2025
Primary outcome: Primary: Change in LDL-Cholesterol — -70.59; -44.78 percent change mg/dL — p=.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Evolocumab (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in LDL-Cholesterol |
-70.59; -44.78 | .0001 sig |
| SECONDARY FDG-PET Imaging Analysis of Inflammation as Mean Standardized Uptake Value (SUV) |
-26.21; -14.52 | .34 |
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 patients with an ACS by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.
Eligibility Criteria
Inclusion Criteria
- Age 25 to 90 years.
- ST elevation myocardial infarction, with compatible symptoms and ECG changes.
- Non ST elevation myocardial infarction, with a troponin I > 5ng/mL and with compatible symptoms and ECG changes.
- Permission of attending physician.
- Ability to understand the risk, benefits, and alternatives of participation.
Exclusion Criteria
- Scheduled for cardiac surgery.
- Current treatment with a PCSK9 antibody.
- Current participation in an intervention clinical trial.
- Latex allergy
- Previous adverse reaction to monoclonal antibodies
- Non-English speaking
- Female of childbearing potential. This is a female subject who has not used acceptable method(s) of birth control (see below) for at least one month prior to screening, unless the subject is sterilized or postmenopausal. Menopause is defined as: 12 months of spontaneous and continuous amenorrhea in a female > 55 year of age.
- Acceptable method(s) of birth control definition: One highly effective method (methods that can achieve a failure rate of less than 1% per year when used consistently and correctly)
- Combined hormonal (estrogen and progestogen) contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence
- Subject likely not to be available to complete all protocol-related study visits or procedures.
Data sourced from ClinicalTrials.gov (NCT04082442). 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.