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

Phase 3

Completed

Conditions: angina
heart attack
high cholesterol
high blood lipids
Vessels supplying the heart with blood
10011082
10013317

Registration Number: NL-OMON48805

Lead Sponsor: Amgen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 43

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
procedure

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
PCSK9
*Baseline OCT does not meet OCT imaging criteria as determined by the Core Lab
technical standards.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in subjects<br /><br>with non ST elevation acute coronary syndrome (NSTE ACS) who are taking<br /><br>maximally tolerated statin therapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the effects of evolocumab on coronary plaque morphology in subjects<br /><br>with NSTE-ACS who are taking maximally tolerated statin therapy</p><br>