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

This study is currently recruiting participants.
Verified April 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01813422
First received: March 15, 2013
Last updated: April 2, 2014
Last verified: April 2014

March 15, 2013
April 2, 2014
May 2013
November 2015   (final data collection date for primary outcome measure)
Nominal change in PAV from baseline to week 78 post randomization, as determined by intravascular ultrasound (IVUS) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Nominal change in PAV from baseline to 78 weeks post randomization, as determined by intravascular ultrasound (IVUS) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01813422 on ClinicalTrials.gov Archive Site
  • Regression (any reduction from baseline) in PAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Nominal change in total atheroma volume (TAV) from baseline to week 78 [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Regression (any reduction from baseline) in TAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects demonstrating regression (any reduction from baseline) in PAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Nominal change in normalized total atheroma volume (TAV) from baseline to 78 weeks [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects demonstrating regression (any reduction from baseline) in TAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
A Randomized, Double-Blind, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization.

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 subjects with coronary artery disease taking lipid lowering therapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: Evolocumab (AMG 145)
    Subjects randomized to the Evolocumab (AMG 145) arm will receive Evolocumab (AMG 145) subcutaneously every 4 weeks
  • Other: Placebo
    Subjects randomized to the placebo arm will receive Placebo subcutaneously every 4 weeks
  • Experimental: Evolocumab (AMG 145)
    Evolocumab (AMG 145)
    Intervention: Drug: Evolocumab (AMG 145)
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
950
January 2016
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or Female ≥ 18 years of age
  • Clinical indication for coronary angiography
  • Subjects already taking statin therapy (e.g. 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 as defined below.

Major Risk Factors (1 required):

  1. Non coronary atherosclerotic vascular disease (documented peripheral arterial disease (PAD), abdominal aortic aneurysm (AAA) or cerebrovascular disease (CD)).
  2. Documented history of myocardial infarction or hospitalization for unstable angina within the last 2 years
  3. Documented Type 2 diabetes mellitus Minor Risk factors (three required): Current cigarette smoker, Hypertension, Low HDL cholesterol, Family history of premature CHD, age or hs-CRP ≥ 2 mg/dL

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)
  • 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 40mm in length); cannot have undergone prior PCI or 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 MI.

Exclusion Criteria:

  • Clinically significant heart disease likely to require intervention during the course of the study
  • Coronary artery bypass surgery less than 6 weeks prior to the qualifying IVUS
  • NYHA III or IV heart failure, or last known left ventricular ejection fraction less than 30%
  • Uncontrolled cardiac arrhythmia
  • Known hemorrhagic stroke
  • Uncontrolled hypertension at randomization
  • Personal or family history of hereditary muscular disorders
  • Fasting TGs ≥ 400 mg/dL (4.5 mmol/L) at screening
  • Subject has taken a CETP inhibitor in the last 12 months prior to LDL-C screening.
  • Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c > 9%)
  • Treatment for more than 2 weeks in the last 3 months prior to LDL-C screening with systemic cyclosporine/steroids/vitamin A or retinol derivatives for the treatment of dermatologic conditions
  • Thyroid stimulating hormone (TSH) < lower limit of normal or > 1.5x upper limit of normal.
  • Moderate to severe renal dysfunction
  • Active liver disease or hepatic dysfunction
  • CK > 3 times the ULN at screening or at end of lipid stabilization period
  • Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction
  • Baseline IVUS does not meet IVUS Core Lab technical standards
  • Unreliability as a study participant
  • Currently enrolled in or less than 30 days since ending another investigational device or drug study
  • Female subject who has not used an acceptable method(s) of birth control for at least 1 month prior to screening, or who is not willing to inform her partner or her participation in the study, unless the female subject is sterilized or postmenopausal
  • Subject is pregnant or breast feeding, planning to become pregnant, or planning to breastfeed during the study
  • History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma)
  • Subject has previously received AMG 145 or any other investigational therapy to inhibit PCSK9
  • Known sensitivity to any of the active substances or their excipients
  • Subject will not be available for protocol-required study visits or procedures
Both
18 Years and older
No
Contact: Amgen Call Center 866-572-6436
United States,   Australia,   Belgium,   Canada,   Chile,   Czech Republic,   Denmark,   France,   Greece,   Hungary,   Iceland,   Ireland,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Norway,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom
 
NCT01813422
20120153
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP