Phase 3 N=970 Randomized Quadruple-blind Treatment

GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound

Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT01813422 ↗

Enrolled (actual)

970

Serious AEs

28.6%

Results posted

Jan 2018

Primary outcome: Primary: Change From Baseline in Percent Atheroma Volume at Week 78 — 0.053; -0.955 percent atheroma volume — p=< 0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Evolocumab (Biological); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Jul 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Percent Atheroma Volume at Week 78	0.053; -0.955	< 0.0001 sig
SECONDARY Change From Baseline in Total Atheroma Volume at Week 78	-0.910; -5.799	< 0.0001 sig
SECONDARY Percentage of Participants With Regression in Percent Atheroma Volume	47.3; 64.3	< 0.0001 sig
SECONDARY Percentage of Participants With Regression in Total Atheroma Volume	48.9; 61.5	0.0002 sig

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 adults with coronary artery disease taking lipid lowering therapy.

Eligibility 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 - 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)
Left main coronary artery 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 9%) at screening.
Moderate to severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m²) at screening.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01813422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.