EVOLVE-MI

This study is being done to learn whether regular healthcare, combined with early treatment with a cholesterol lowering drug called evolocumab (Repatha®) reduces heart attack, stroke, procedures to improve blood flow, and death, compared to regular healthcare alone. 

Participants are expected to be in the trial for 3.5 years or longer. 

Inclusion Criteria:

1. Subjects has provided informed consent prior to initiation of any study specific activities
2. Age >18 years
3. Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease  

Exclusion Criteria:

1. Subjects requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening
2. Subjects with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension, stress induced cardiomyopathy)
3. History of evidence of clinically significant disease (eg, malignancy, respiratory, gastrointestinal, renal or psychiatric disease) or unstable disorder that, in the opinion of the investigator, would pose a risk to subject's safety or interfere with the study assessments, procedures, completion or result in a life expectancy of less than 1 year. 4. 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 5. Currently receiving treatment in another investigational (not approved for any use in the country the subject is to be randomized) device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies), with the exception of therapies for COVID-19. Other investigational procedures while participating in this study are excluded. 6. Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 15 weeks after the last dose of investigational product. 7. Female subjects who are breastfeeding or who plan to breastfeed while on study through 15 weeks after the last dose of investigational product. 8. Female subjects planning to become pregnant while on study through 15 weeks after the last dose of investigational product. 9. Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test. 10. Subject has known sensitivity to any of the products or components to be administered during dosing. 11. Subject likely to not be available to complete all protocol-required procedures, and/or to comply with all required study procedures (eg, clinical event assessments) to the best of the subject and investigator’s knowledge.