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

Amgen Inc.0 sites150 target enrollmentAugust 28, 2018

Overview

No summary available.

Registry

who.int

Start Date

August 28, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•Key Inclusion Criteria
•Age \= 18 years at screening.
•Clinical indication for coronary angiography during admission due to NSTE\-ACS with interventional treatment of culprit plaque.
•LDL\-C level via local lab assessment based on statin use at screening:
•\- No statin use: \= 130 mg/dL
•\- Low\- or moderate\-intensity statin use: \= 80 mg/dL
•\- High\-intensity statin use: \= 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.
•Meet all the following criteria at the qualifying coronary angiogram:

•Subjects are excluded from the study if any of the following criteria apply.
•Disease Related:
•\-ST\-segment elevation myocardial infarction (STEMI) or left bundle branch block (LBBB).
•\-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.
•Diagnostic Assessments
•\-Triglycerides \= 400 mg/dL (4\.5 mmol/L) at screening.
•\-Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1\.73m2 at screening.
•Other Medical Conditions