NCT04082442CompletedPhase 2
Evolocumab in Patients With Acute MI
Evolocumab in Patients With Acute Myocardial Infarction: A Double-blind, Prospective, Randomized Placebo-Controlled Study
Source: ClinicalTrials.gov · Last updated 23 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 5 Sept 2019
- Start date
- 1 Sept 2019
- Primary completion date
- 25 Oct 2024
- Lead sponsor
- Johns Hopkins University
- Diseases
- Coronary artery disease
- NCT number
- NCT04082442
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 100
- From 1 Sept 2019 to the primary completion date, 25 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with a PCSK9 antibody.
- Previous adverse reaction to monoclonal antibodies
- 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
Other illness
- Scheduled for cardiac surgery.
- Latex allergy
Other
- Current participation in an intervention clinical trial.
- Non-English speaking
- Subject likely not to be available to complete all protocol-related study visits or procedures.
Who the study is looking for
- 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.
Age in the registry: 25 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.