Trials / Completed
CompletedNCT03570697
Imaging of Coronary Plaques in Participants Treated With Evolocumab
High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 164 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-11-19
- Primary completion
- 2020-12-18
- Completion
- 2021-01-21
- First posted
- 2018-06-27
- Last updated
- 2022-05-03
- Results posted
- 2021-11-24
Locations
33 sites across 7 countries: United States, Australia, Czechia, Germany, Hungary, Italy, Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03570697. Inclusion in this directory is not an endorsement.