Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

Phase 1

• Conditions: Dyslipidemia; MedDRA version: 21.0Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-004565-14-IT
• Lead Sponsor: AMGEN INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12000

Inclusion Criteria

-Subject has provided informed consent prior to initiation of any study specific activities/procedures
-Adult subjects > = 50 years (men) or > = 55 years (women) to < 80 years of age (either sex) and meeting lipid criteria
-Subjects must have an LDL-C > = 90 mg/dL (> = 2.3 mmol/L) or non-HDLC > = 120 mg/dL (> = 3.1 mmol/L) OR apolipoprotein B >= 80 mg/dL (>= 1.56 µmol/L)
1. Lipid entry criteria can be measured up to 3 months prior to screening in the absence of changes to background therapy
2. Lipid criteria should be assessed after >= 2 weeks of stable, optimized lipid-lowering therapy
3. The most recent results (historical or screening) must be used
-Diagnostic evidence of at least 1 of the following (A – D) at screening:
A. Significant coronary artery disease meeting at least 1 of the following criteria:
1. History of coronary revascularization with multi-vessel coronary disease as evidenced by any of the following:
(a) percutaneous coronary intervention (PCI) of 2 or more vessels, including branch arteries
(b) PCI or coronary artery bypass grafting (CABG) with residual > =50% stenosis in a separate, unrevascularized segment or vessel, or
(c) multi-vessel CABG 5 years or more prior to screening
2. Significant coronary disease without prior revascularization as evidenced by either a > = 70% stenosis of at least 1 coronary artery, > = 50% stenosis of 2 or more coronary arteries, or > = 50% stenosis of the left main coronary artery
3. known coronary artery calcium score > = 100 in subjects without a coronary artery revascularization prior to randomization
B. Significant atherosclerotic cerebrovascular disease meeting at least 1 of the following criteria:
1. prior transient ischemic attack with > = 50% carotid stenosis
2. internal or external carotid artery stenosis of > = 70% or 2 or more > = 50% stenosis
3. prior internal or external carotid artery revascularization
C. Significant peripheral arterial disease meeting at least 1 of the following criteria:
1. > = 50% stenosis in a limb artery
2. history of abdominal aorta treatment (percutaneous and surgical) due to atherosclerotic disease
3. ankle brachial index (ABI) < 0.85

*Please refer to protocol for the full list
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 7215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5785

Exclusion Criteria

1. Disease Related
- MI or stroke prior to randomization
- CABG < 3 months prior to screening
- Uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator.
- Atrial fibrillation or atrial flutter not on anticoagulation therapy (vitamin K antagonist, heparin, low-molecular weight heparin, fondaparinux, or non-Vitamin K antagonist oral anticoagulant)
- Last measured left-ventricular ejection fraction < 30% or New York Heart Association (NYHA) Functional Class III/IV
- Planned arterial revascularization
2. Diagnostic Assessments
- Triglycerides > =500 mg/dL (5.7 mmol/L) measured up to 3 months prior to screening. The most recent results must be used.
- End stage renal disease (ESRD), defined as an eGFR < 15 mL/min/1.73 m2 or receiving dialysis measured up to 6 months prior to screening. The most recent results must be used.

*Please refer to the protocol for the full list

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified