Evolocumab in Patients With Acute MI

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT04082442

Run by

Johns Hopkins University

People needed

100

Starts

2019-09-01

Expected to finish

2024-10-25

Last updated by the study team

2025-10-23

Who can join

Age: 25 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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