Status:
COMPLETED
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
Lead Sponsor:
Amgen
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in ...
Eligibility Criteria
Inclusion
- Clinical indication for coronary angiography
- Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
- Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -\< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors
- Subjects must meet the following criteria at the qualifying coronary catheterization procedure:
- Evidence of coronary heart disease (at least one lesion in a native coronary artery that has \> 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)
- Left main coronary artery \< 50% reduction in lumen diameter by visual estimation
- Target coronary artery for IVUS must be accessible to the IVUS catheter, must not have a \> 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior PCI or coronary artery bypass graft (CABG) and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (MI).
Exclusion
- Coronary artery bypass graft surgery \< 6 weeks prior to the qualifying IVUS
- New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30%
- Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
- Known hemorrhagic stroke
- Uncontrolled hypertension at randomization
- Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening
- Type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin A1c \[HbA1c\] \> 9%) at screening.
- Moderate to severe renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73m²) at screening.
Key Trial Info
Start Date :
April 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2016
Estimated Enrollment :
970 Patients enrolled
Trial Details
Trial ID
NCT01813422
Start Date
April 18 2013
End Date
July 29 2016
Last Update
February 20 2019
Active Locations (226)
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1
Research Site
Huntsville, Alabama, United States, 35801
2
Research Site
Mobile, Alabama, United States, 36608
3
Research Site
Little Rock, Arkansas, United States, 72211
4
Research Site
La Jolla, California, United States, 92037