NL-OMON48805
Completed
Phase 3
High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS) - 20160184 HUYGENS
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- angina
- Sponsor
- Amgen
- Enrollment
- 43
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\*Clinical indication for coronary angiography during admission due to non ST
- •segment elevation acute coronary syndrome (NSTE\-ACS) with interventional
- •treatment of culprit plaque.
- •\*Subjects must have an eligible LDL\-C level via local laboratory assessment in
- •between admission for ACS and coronary angiogram.
- •\*Subject must be on optimal statin therapy per local guidelines prior to
- •randomization.
- •\*Subjects must meet all of the criteria at the qualifying coronary angiogram
Exclusion Criteria
- •\*Subject has taken a cholesterol ester transfer protein (CETP) inhibitor,
- •(i.e., anacetrapib, dalcetrapib, evacetrapib), mipomersen , lomitapide or has
- •undergone LDL apheresis in the last 12 months prior to LDL\-C screening
- •\*Subject has previously received evolocumab or any other therapy to inhibit
- •\*Baseline OCT does not meet OCT imaging criteria as determined by the Core Lab
- •technical standards.
Outcomes
Primary Outcomes
Not specified
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