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Imaging of Coronary Plaques in Participants Treated With Evolocumab

NCT03570697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2022-05-03

Study results available
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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.

Conditions

  • Coronary Artery Disease (CAD)

Interventions

DRUG

Evolocumab

Participants will receive evolocumab (AMG 145) subcutaneous monthly.

DRUG

Placebo

Participants will receive matching placebo subcutaneous monthly.

DRUG

Statin therapy

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.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2020-12-18
Completion
2021-01-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570697 on ClinicalTrials.gov