Overview

Evolocumab in Patients With Acute MI

Status:
Recruiting

Trial end date:
2021-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Johns Hopkins University

Collaborators:

Amgen
Washington University School of Medicine

Treatments:

Antibodies, Monoclonal
Evolocumab

Criteria

Inclusion Criteria:

1. Age 25 to 90 years.

2. ST elevation myocardial infarction, with compatible symptoms and ECG changes.

3. Non ST elevation myocardial infarction, with a troponin I > 5ng/mL and with compatible
symptoms and ECG changes.

4. Permission of attending physician.

5. Ability to understand the risk, benefits, and alternatives of participation.

Exclusion Criteria:

1. Scheduled for cardiac surgery.

2. Current treatment with a PCSK9 antibody.

3. Current participation in an intervention clinical trial.

4. Latex allergy

5. Previous adverse reaction to monoclonal antibodies

6. Non-English speaking

7. 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

8. Subject likely not to be available to complete all protocol-related study visits or
procedures.