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Imaging of Coronary Plaques in Participants Treated With Evolocumab | Clinical Trials | Clareo Health

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Imaging of Coronary Plaques in Participants Treated With Evolocumab

High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS)

NCT03570697•Amgen

Summary

To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in participants with non-ST-elevation acute coronary syndrome (NSTE-ACS) who are taking maximally tolerated statin therapy.

Detailed Description

This study seeks to identify morphologic changes, such as increase in FCT in atherosclerotic plaques associated with treatment with evolocumab and maximally tolerated statin therapy with or without additional lipid-modifying medication in patients presenting with NSTE-ACS using optical coherence tomography (OCT; primary, secondary, and exploratory endpoints).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provided informed consent prior to initiation of any study-specific activities/procedures.
•Age greater than or equal to 18 years at screening
•Clinical indication for coronary angiography during admission due to NSTE-ACS with interventional treatment of culprit plaque
•An eligible low-density lipoprotein cholesterol (LDL-C) level via local lab assessment based on statin use at screening
•No statin use: greater than or equal to 130 mg/dL Low- or moderate-intensity statin use greater than or equal to 80 mg/dL High-intensity statin use greater than or equal to 60 mg/dL
•On maximally tolerated statin therapy in accordance with standard of care per local guidelines prior to randomization.
•Tolerates placebo run-in injection at screening
•Meets all the following criteria at the qualifying coronary angiogram:
•Angiographic evidence of coronary artery disease (CAD) with greater than or equal to 20% reduction of lumen diameter by angiographic visual estimation, in addition to the culprit plaque.
•Left main coronary artery must not have a greater than 50% reduction in lumen diameter by visual angiographic estimation.
+8 more criteria

Exclusion Criteria

•ST-segment elevation myocardial infarction (STEMI) or left bundle branch block (LBBB).
•Acute coronary syndromes (ACS) likely to be caused by a non-atherosclerotic process, in the opinion of the investigator (ie, type 2 myocardial infarction, which is characterized by an imbalance between myocardial oxygen demand and supply).
•Clinically significant heart disease which in the opinion of the investigator is likely to require coronary bypass surgery, PCI (does not apply to PCI of non-STEMI (NSTEMI) during initial screening angiogram), surgical or percutaneous valve repair and/or replacement during the course of the study.
•Any cardiac surgery within 6 weeks prior to screening.
•Triglycerides greater than or equal to 400 mg/dL (4.5 mmol/L) at screening.
•Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m\^2 at screening.
•Malignancy except non-melanoma skin cancers, cervical, or breast ductal carcinoma in situ within the last 5 years.
•Intolerant to statins as determined by principal investigator.
•Previously received or receiving evolocumab or any other therapy to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9).
•Previously received a cholesterol ester transfer protein (CETP) inhibitor (ie, anacetrapib, dalcetrapib, evacetrapib), mipomersen, lomitapide, or has undergone LDL-apheresis in the last 12 months prior to LDL-C screening.
+6 more criteria

Locations (33)

University of California at Los Angeles

Los Angeles, California, United States

Medstar Heart and Vascular Institute

Washington D.C., District of Columbia, United States

Midwest Cardiovascular Research And Education Foundation

Elkhart, Indiana, United States

Saint Louis University Hospital

St Louis, Missouri, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Monash Medical Centre

Clayton, Victoria, Australia

The Northern Hospital

Epping, Victoria, Australia

Key Dates

Start Date

November 19, 2018

Primary Completion Date

December 18, 2020

Completion Date

January 21, 2021

Last Updated

May 3, 2022

Enrollment

164

ACTUAL participants

Conditions

Coronary Artery Disease (CAD)

Interventions

Evolocumab

DRUG

Placebo

DRUG

Statin therapy

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Imaging of Coronary Plaques in Participants Treated With Evolocumab

Inclusion Criteria

Exclusion Criteria

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