Status:
COMPLETED
Evolocumab in Patients With Acute MI
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Amgen
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
25-90 years
Phase:
PHASE2
Brief 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 i...
Detailed Description
Despite aggressive early intervention and current secondary prevention strategies, many patients who survive hospitalization for an acute coronary syndrome (ACS) experience subsequent unfavorable outc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04082442
Start Date
September 1 2019
End Date
October 25 2024
Last Update
October 23 2025
Active Locations (1)
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1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287