EVOLVE-MI: A Pragmatic Randomized Multicenter Trial of EVOLocumab Administered Very Early to Reduce the Risk of Cardiovascular Events in Patients Hospitalized With Acute Myocardial Infarction

Brief description of study

This study will compare treating participants with standard care, combined with early treatment with a cholesterol lowering drug called evolocumab (Repatha®) to treating participants with standard care alone. The study will measure reductions in heart attacks and strokes, procedures to improve blood flow, and death, compared to regular healthcare alone.

Detailed description of study

Participants are randomized to either receive the study drug (evolocumab) in addition to regular healthcare or to receive regular healthcare alone. Those who receive evolocumab will be taught how to inject themselves with the study drug at home.

All participants will receive an email from REDCap Cloud about every 12 weeks prompting them to complete a study questionnaire. Participation will last at least 3.5 years.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Acute Myocardial Infarction (MI)
Age: Between 18 Years - 100 Years
Gender: All

Inclusion

Age greater than or equal to 18 years
Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease

Exclusion

History or evidence of clinically significant disease (e.g., malignancy, respiratory, gastrointestinal, renal or psychiatric disease)
Currently receiving treatment in another investigational device or drug study
Previously received or receiving any therapy to inhibit PCSK9 in the following timeframe:

Evolocumab, alirocumab, or any other therapeutic against PCSK9 within 3 months prior to screening
Inclisiran within 6 months prior to screening

Updated on 09 Mar 2024. Study ID: 2022-74

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