Assessment of Coronary Plaques in a Global Evolocumab Study
- Conditions
- DyslipidemiaMedDRA version: 20.1Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861MedDRA version: 20.0Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-003236-37-CZ
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Key Inclusion Criteria
•Age = 18 years at screening.
•Clinical indication for coronary angiography during admission due to NSTE-ACS with interventional treatment of culprit plaque.
•LDL-C level via local lab assessment based on statin use at screening:
- No statin use: = 130 mg/dL
- Low- or moderate-intensity statin use: = 80 mg/dL
- High-intensity statin use: = 60 mg/dL
•On maximally tolerated statin therapy in accordance with standard of care per local guidelines prior to randomization.
•Tolerates placebo run-in injection at screening.
•Meet all the following criteria at the qualifying coronary angiogram:
- Angiographic evidence of coronary artery disease (CAD) with = 20% reduction of lumen diameter by angiographic visual estimation, in addition to the culprit plaque.
- Left main coronary artery must not have a > 50% reduction in lumen diameter by visual angiographic estimation.
- Targeted vessel:
-may not be the culprit vessel for the current or a previous myocardial infarction (MI).
-has not undergone prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), and may not be a bypass graft.
-may not be a candidate for PCI or CABG currently or over the next 12 months, in the opinion of the investigator.
-must be accessible by the OCT catheter.
- Targeted segment:
-must have up to 50% but not > 50% reduction in lumen diameter by visual angiographic estimation and must be at least 40 mm in length.
-must contain at least 1 image with an FCT of = 120 µm and at least 1 image with a lipid arc of > 90° as determined by the imaging core laboratory.
-distal plaques of up to 50% stenosis by visual angiographic estimation are permitted, provided that such stenosis is not a target for PCI or CABG.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 102
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48
Subjects are excluded from the study if any of the following criteria apply.
•Disease Related:
-ST-segment elevation myocardial infarction (STEMI) or left bundle branch block (LBBB).
-ACS likely to be caused by a non-atherosclerotic process, in the opinion of the investigator (ie, type 2 myocardial infarction, which is characterized by an imbalance between myocardial oxygen demand and supply).
-Clinically significant heart disease which in the opinion of the investigator is likely to require coronary bypass surgery, PCI (does not apply to PCI of non STEMI (NSTEMI) during initial screening angiogram), surgical or percutaneous valve repair and/or replacement during the course of the study.
-Any cardiac surgery within 6 weeks prior to screening.
•Diagnostic Assessments
-Triglycerides = 400 mg/dL (4.5 mmol/L) at screening.
-Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 at screening.
•Other Medical Conditions
-Malignancy except non-melanoma skin cancers, cervical, or breast ductal carcinoma in situ within the last 5 years.
-Intolerant to statins as determined by principal investigator.
Prior/Concomitant Therapy
-Previously received or receiving evolocumab or any other therapy to inhibit PCSK9.
-Previously received a cholesterol ester transfer protein (CETP) inhibitor (ie, anacetrapib, dalcetrapib, evacetrapib), mipomersen, lomitapide, or has undergone LDL apheresis in the last 12 months prior to LDL-C screening.
•Prior/Concurrent Clinical Study Experience
-Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
•Other Exclusions
-Baseline OCT does not meet OCT imaging criteria as determined by the imagine core laboratory technical standards.
-Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 15 weeks after the last dose of investigational product. (Females of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test.)
-Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 15 weeks after the last dose of investigational product. Refer to Appendix 5 for additional contraceptive information.
-Female subject who has not used an acceptable method(s) of birth control for at least 1 month prior to screening, unless the female subject is sterilized or postmenopausal.
-Known sensitivity to any of the products or components (eg, carboxymethylcellulose) to be administered during dosing.
-Not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject’s and investigator’s knowledge.
-Unreliability based on the investigator's (or designee’s) knowledge (eg, alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis).
-History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfe
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method