CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 164 enrolled
Drug / intervention
Evolocumab +2 moredrug
Likely dose
Statin therapy 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03570697
NCT03570697Phase 3Completed
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High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS)

Amgen·interventional·Posted Jun 27, 2018·Updated May 3, 2022

In Brief

A Phase 3 clinical trial evaluating Evolocumab, Placebo, and 1 other intervention for Coronary Artery Disease (CAD). Completed, enrolled 164 participants across 33 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease (CAD)
CountriesAustralia, Czechia, Germany, Hungary, Italy, Netherlands, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 27, 2018
Enrollment StartNov 19, 2018
Primary CompletionDec 18, 2020
Study CompletionJan 21, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.0 years ago

Interventions

Evolocumabdrug

Participants will receive evolocumab (AMG 145) subcutaneous monthly.

Placebodrug

Participants will receive matching placebo subcutaneous monthly.

Statin therapydrug

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.