AMG 145 20120153 GLAGOV
Abgeschlossen · 2014 bis 2018
Rickli Hans, Weilenmann Daniel, Gemperle Michaela, Rigger Johannes
Double-Blind, Randomized, Multi-Center, Placebo-Controlled, Parallel Group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden
As Measured By Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization
To evaluate the effect of AMG 145 on the change in burden of coronary atherosclerosis as
measured by percent atheroma volume (PAV) in subjects with coronary artery disease (CAD)
requiring angiography for a clinical indication who are taking statins.
To evaluate the effect of AMG 145 on the change in normalized total atheroma volume (TAV)
and the percentage of subjects who demonstrate regression of coronary atherosclerosis.
Hypothesis: The primary hypothesis is that (low-density lipoprotein cholesterol) LDL-C lowering
with AMG 145 420 mg subcutaneous (SC) will result in a greater change from baseline in PAV
at week 78 than placebo in subjects with coronary artery disease taking background statin