Effects of AMG 145 Treatment on Atherosclerotic Disease GLAGOV
Research type
Research Study
Full title
A Randomized, Multi-Center, Placebo-Controlled, Parallel Group Study to Determine the Effects of AMG-145 Treatment on Atherosclerotic Disease Burden As Measured By Intravascular Ultrasound in Patients Undergoing Coronary Catheterization
IRAS ID
134293
Contact name
Azfar Zaman
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2012-004208-37
Clinicaltrials.gov Identifier
Research summary
Cardiovascular disease is a leading cause of death in developed countries. It’s commonly linked with having high cholesterol levels in the blood. This cholesterol can be deposited in the walls of blood vessels making them narrow which can reduce the blood flow to critical areas of the body, such as the heart. By lowering cholesterol levels in the blood, the amount deposited in the walls of the blood vessels should also decrease. A common method to lower cholesterol is using medications such as statins.
AMG145 is an experimental drug that works differently to statins and other cholesterol lowering medications and may lower cholesterol. The purpose of this study is to determine whether AMG145 alongside statins can reduce the volume of fatty deposits found in the hearts’ blood vessels.
Patients will be identified based upon a routine clinical requirement to have an angiogram (procedure that allows doctors to assess vessels around the heart). Prior to the angiogram consent will be taken and if it confirms the patient is suitable for the study patients will undergo an Intravenous Ultrasound (IVUS) which provides images of the hearts blood vessel. An eligibility assessment will be performed and if eligible, patients then enter a lipid stabilization period to ensure they are on a stable, well controlled dose of statin.
The patient will then be on study for 78 weeks having study product administered once a month. Other assessments the subjects will have during this time period are blood collections, vital signs, physical exams, dietary advice, height/weight and waist circumference measurements. An ECG which measures the activity of the heart will also be done at the start and end of trial. At week 78 another IVUS will be done and images compared to those at the start of trial.
All data collected will be reviewed by an external independent data monitoring committee to ensure there is no avoidable increased risk for harm to patients.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
13/NE/0238
Date of REC Opinion
9 Oct 2013
REC opinion
Further Information Favourable Opinion