Imaging of Coronary Plaques in Participants Treated With Evolocumab

Part of paid clinical trials in Los Angeles, California.

Sponsor
Amgen
Study ID
NCT03570697
Phase
PHASE3
Status
Completed

Conditions

  • Coronary Artery Disease (CAD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Participants will receive evolocumab (AMG 145) subcutaneous monthly.
  • Placebo — DRUG
    Participants will receive matching placebo subcutaneous monthly.
  • Statin therapy — DRUG
    high-intensity statin treatment with atorvastatin ≥ 40 mg daily or equivalent as background therapy Investigators will up-titrate statin therapy to the maximally tolerated dose, in accordance with local guidelines, prior to randomization.

Study Details

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.

Key Dates

Start date
Nov 19, 2018
Status verified
Apr 2022
Primary completion
Dec 18, 2020
Completion
Jan 21, 2021

Study Design

Enrollment
164 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab
    Participants receive evolocumab subcutaneous injection once every month (QM) for 48 weeks. As prescribed and provided by the investigator, participants will be treated with maximally tolerated statin therapy, not expected to change for the duration of the study participation.
  • Placebo Comparator: Placebo
    Participants receive placebo subcutaneous injection QM for 48 weeks. As prescribed and provided by the Investigator, participants will be treated with maximally tolerated statin therapy, not expected to change for the duration of the study participation.

Primary Outcome Measure

Absolute Change From Baseline in Minimum FCT [ Time Frame: Baseline, week 50 ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of California at Los AngelesLos AngelesCalifornia90095-
Medstar Heart and Vascular InstituteWashington D.C.District of Columbia20010-
Midwest Cardiovascular Research And Education FoundationElkhartIndiana46514-
Saint Louis University HospitalSt LouisMissouri63110-
University Hospitals Cleveland Medical CenterClevelandOhio44106-

Find similar trials in Los Angeles, CA

By research site
University of California at Los Angeles· Los Angeles, CAMedstar Heart and Vascular Institute· Washington D.C., DCMidwest Cardiovascular Research And Education Foundation· Elkhart, INSaint Louis University Hospital· St Louis, MOUniversity Hospitals Cleveland Medical Center· Cleveland, OH

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