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Purpose

The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]).

Conditions

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Participants requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening - Participants with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension, stress induced cardiomyopathy)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Evolocumab + Routine Lipid Management 		Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
  • Drug: Evolocumab
    Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.
    Other names:
    • Repatha
    • AMG 145
  • Drug: Routine Lipid Management
    Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
Active Comparator
Routine Lipid Management 		Participants will receive routine lipid management per standard of care (SoC).
  • Drug: Evolocumab
    Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.
    Other names:
    • Repatha
    • AMG 145
  • Drug: Routine Lipid Management
    Routine lipid management therapies will be administered at the discretion of the investigator per SoC.

More Details

Status
Active, not recruiting
Sponsor
Amgen

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.