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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03872401




Registration number
NCT03872401
Ethics application status
Date submitted
11/03/2019
Date registered
13/03/2019
Date last updated
7/04/2020

Titles & IDs
Public title
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
Scientific title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
Secondary ID [1] 0 0
2018-004565-14
Secondary ID [2] 0 0
20170625
Universal Trial Number (UTN)
Trial acronym
VESALIUS-CV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease (CHD) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Evolocumab
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W) for a minimum of 4 years.

Experimental: Evolocumab 140 mg Q2W - Participants will receive 140 mg evolocumab by subcutaneous injection once every 2 weeks for a minimum of 4 years.


Treatment: Drugs: Evolocumab
Administered subcutaneously using an autoinjector pen.

Treatment: Drugs: Placebo
Administered subcutaneously using an autoinjector pen.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Coronary Heart Disease Death, Myocardial Infarction, or Ischemic Stroke - Time to coronary heart disease (CHD) death, myocardial infarction (MI), or ischemic stroke, whichever occurs first.
Timepoint [1] 0 0
From randomization; for approximately a median of 4.5 years
Primary outcome [2] 0 0
Time to Coronary Heart Disease Death, Myocardial Infarction, Ischemic Stroke, or Any Ischemia-driven Arterial Sroke - Time to CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first.
Timepoint [2] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [1] 0 0
Time to MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization
Timepoint [1] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [2] 0 0
Time to CHD Death, MI, or Any Ischemia-driven Arterial Revascularization
Timepoint [2] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [3] 0 0
Time to Cardiovascular Death, MI, or Stroke
Timepoint [3] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [4] 0 0
Time to Myocardial Infarction
Timepoint [4] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [5] 0 0
Time to Any Ischemia-driven Arterial Revascularization
Timepoint [5] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [6] 0 0
Time to CHD Death
Timepoint [6] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [7] 0 0
Time to Cardiovascular Death
Timepoint [7] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [8] 0 0
Time to All Cause of Death
Timepoint [8] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [9] 0 0
Time to Ischemic Stroke
Timepoint [9] 0 0
From randomization; for approximately a median of 4.5 years

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Age: Adult subjects = 50 (men) or = 55 (women) to ? 80 years of age (either sex) and
meeting lipid criteria

2. Low-density lipoprotein cholesterol (LDL-C) = 90 mg/dL (= 2.3 mmol/L) or
non-high-density lipoprotein cholesterol (non-HDL) = 120 mg/dL (= 3.1 mmol/L) at
screening, or apolipoprotein B = 80 mg/dL (= 1.56 µmol/L)

3. Evidence of at least one of the following at screening (without prior myocardial
infarction or stroke):

A. Significant coronary artery disease (CAD) B. Significant atherosclerotic
cerebrovascular disease C. Significant peripheral arterial disease D. Diabetes
mellitus

4. At least 1 high-risk feature
Minimum age
50 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

- MI or stroke prior to randomization

- Coronary artery bypass grafting (CABG) ? 3 months prior to screening

- Estimated glomerular filtration rate (eGFR) ? 15 mL/min/1.73 m²

- Uncontrolled or recurrent ventricular tachycardia in the absence of an
implantable-cardioverter defibrillator.

- Atrial fibrillation not on anticoagulation therapy (vitamin K antagonist, heparin, low
molecular weight heparin, fondaparinux,or non-Vitamin K antagonist oral anticoagulant)

- Fasting triglycerides = 500 mg/dL (5.7 mmol/L) at screening

- Last measured left-ventricular ejection fraction ? 30% or New York Heart Association
(NYHA) Functional Class III/IV

- Planned arterial revascularization

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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ACT,NSW,QLD,SA,VIC,WA
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2605 - Garran
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4066 - Auchenflower
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4064 - Milton
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5068 - Leabrook
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3168 - Clayton
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3076 - Epping
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3220 - Geelong
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5068 - Joondalup
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4102 - Woolloongabba
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Yeovil

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C)
with evolocumab on major cardiovascular events in adults without a prior myocardial
infarction (MI) or stroke who are at high risk of a cardiovascular event.
Trial website
https://clinicaltrials.gov/show/NCT03872401
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03872401