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Study Complete
Sponsor ID
20120153

GLobal Assessment of plaque reGression with a PCSK9 antibOdy as measured by intraVascular ultrasoundGLAGOV

Sponsor ID
20120153
Clinicaltrials.gov ID
NCT01813422
EUCTIS ID
N/A
EudraCT ID
2012-004208-37
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Study Details

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 adults with coronary artery disease taking lipid lowering therapy.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
970
Additional Study Details

Protocol Summary

Primary Outcome Measures

Nominal change in PAV from baseline to week 78 post randomization, as determined by intravascular ultrasound (IVUS)

Timeframe: 78 weeks

Secondary Outcome Measures

Regression (any reduction from baseline) in PAV

Timeframe: 78 weeks

Nominal change in total atheroma volume (TAV) from baseline to week 78

Timeframe: 78 weeks

Regression (any reduction from baseline) in TAV

Timeframe: 78 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Covington, LA, United States, 70433
Status
Recruiting
Location
Research Site
Little Rock, AR, United States, 72211
Status
Completed
Location
Research Site
Adelaide, SA, Australia, 5000
Status
Recruiting
Location
Research Site
Alkmaar, Netherlands, 1815 JD
Status
Recruiting
Location
Research Site
Athens, Greece, 11527
Status
Recruiting
Location
Research Site
Atlanta, GA, United States, 30342
Status
Recruiting
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Study Info
Age
18 - 99 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Apr 2013 - Jul 2016
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - 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 Criteria:
    - 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.