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OpenTrials
Completed

NCT Number: NCT03515304

Evolocumab in Acute Coronary Syndrome

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 an important subset of ACS patients, those with non-ST elevation myocardial infarction (NSTEMI) by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

25 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Steven Paul Schulman

Baltimore, Maryland, 21136, United States

About this study

In a placebo-controlled, randomized double blind trial, the addition of evolocumab to standard care in NSTEMI patients (1) decreases LDL-C during hospitalization and at 30 days, (2) decreases vascular/plaque and myocardial inflammation as assessed by Positron Emission Tomography (PET) scanning at 30 days, and improves (3) serum markers of endothelial function at hospital discharge and at 30 days, and (4) echocardiographic assessment of left ventricular function at 30 days and six months.

This is the first PCSK9 inhibitor trial which examines these outcomes in the ACS patient population. It will provide valuable data on the extent and time course of LDL-C reduction as well as the impact of inhibition on inflammatory markers and on imaging assessment of vascular and myocardial inflammation, all of which may significantly impact important clinical outcomes in this high risk patient cohort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non ST segment elevation myocardial infarction
  • Troponin I >/ 5.0 ng/dL
  • Permission of attending physician

Exclusion criteria

  • ST elevation myocardial infarction
  • Patients requiring invasive hemodynamic support
  • Scheduled for cardiac surgery
  • Current or prior treatment with a PCSK9 antibody
  • Current participation in an intervention clinical trial
  • Female of childbearing potential who has not used acceptable method(s) of birth control for at least one month prior to screening
  • Contraindication to statin therapy
  • Subject likely not able to complete protocol related visits or procedures
  • Latex allergy
  • History of hypersensitivity to any monoclonal antibody

Treatment and study plan

Evolocumab

Drug

420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.

Other names: Repatha

Placebo

Drug

Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.

Primary outcomes

  1. Percent Change in LDL-Cholesterol

    Time frame: Baseline to 30 days

  2. Change From Baseline in Target to Background Ratio Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Scans

    Time frame: Baseline to 30 days

    PET Imaging for Inflammation: Change from baseline in target to background ratio Fluorodeoxyglucose (FDG) PET scans in the myocardium.

Secondary outcomes

  1. Left Ventricular Volume as Assessed by Echocardiography

    Time frame: Baseline, day 30 and 6 months

    Evaluation of left ventricular volume (ml) by echocardiography

  2. Ejection Fraction as Assessed by Echocardiography

    Time frame: Baseline, day 30 and 6 months

    Evaluation of ejection fraction (%) by echocardiography

  3. Plasma Proprotein Convertase Subtilisin Kexin-9 (PCSK9) Levels (ng/ml)

    Time frame: Baseline, day 30 and 6 months

    Change from baseline in PCSK9 serum levels

  4. PET-FDG Assessed Vascular Inflammation as Assessed by Standardized Uptake Value (SUV)

    Time frame: Baseline to day 30

    Target artery to background ratio endpoint (standardized uptake value) for left carotid artery

  5. High Sensitivity C-reactive Protein (Hs-CRP) Serum Levels

    Time frame: Baseline, day 30 and 6 months

    hs-CRP serum levels (mg/L)

  6. Change in Serum Levels of Interleukin 6

    Time frame: Baseline, day 30 and 6 months

    Change in baseline in serum levels of Interleukin 6 (pg/mL)

  7. Serum Levels of Interleukin 10

    Time frame: Baseline, day 30 and 6 months

    Serum levels of Interleukin 10 (pg/mL)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Amgen

Registry information

Official study title

Evolocumab in Acute Coronary Syndrome: A Double-Blind Randomized Placebo Controlled Study

Acronym: EVACS

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
May 3, 2018
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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