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 Subjects Undergoing Coronary Catheterization (GLAGOV study, 20120153)

Phase 3

Completed

• Conditions: dyslipidemia/atherosclerosis; elevated cholesterol/atherosclerosis; 10013317; 10003216

• Registration Number: NL-OMON41708
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 148

Inclusion Criteria

- Males and females *18 years.
- Clinical indication for coronary angiography.
- Coronary angiogram during screening: criteria see protocol page 35.
- Subjects already taking statin therapy, regulatory-approved sustained-release niacin (eg Niaspan*) or ezetimibe at initial screening must have been on a stable dose for at least 4 weeks prior to the lipid panel used for the screening LDL-C. Subjects not currently taking lipid-regulating therapy can be screened but must enter the study via a lipid stabilization period or subjects who are intolerant to statins (limited to no more than approximately 10% of total planned enrollment) must meet statin intolerance entry criteria in Appendix G.
- Fasting LDL-C * 2,07 mmol/L with or without additional risk factors or *1,55-2,07 mmol/L in the presence of 1 major or 3 minor risk factors (see protocol page 36).

Exclusion Criteria

- Clinically significant heart disease which in the opinion of the Principal Investigator is likely to require intervention during the course of the study.
- CAB <6 weeks prior to screening.
- NYHA III or IV heart failure, or last known left ventricular ejection fraction < 30%.
- Known hemorrhagic stroke.
- Uncontrolled cardiac arrhythmia, hypertension and/or type 2 diabetes (see protocol page 38 for details).
- Fasting triglycerides *4,5 mmol/L.
- Type 1 diabetes.
- CETP inhibitor or mipomersen or lomitapide in the last 12 months.
- eGFR <30 ml/min/1.73m2.
- Active infection.
- Pregnancy, inadequate contraception, breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percent atheroma volume (PAV) from baseline to 78 weeks post randomization.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse events, nominal change in normalized total atheroma volume (TAV), %<br /><br>patients demonstrating regression in PAV or TAV.</p><br>