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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03872401
Ethics application status
Date submitted
11/03/2019
Date registered
13/03/2019
Date last updated
13/05/2024

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).

Experimental: Evolocumab 140 mg Q2W - Participants will receive 140 mg evolocumab by subcutaneous injection Q2W.


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
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
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 Ischemic Stroke
Timepoint [3] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [4] 0 0
Time to CHD Death or MI
Timepoint [4] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [5] 0 0
Time to Myocardial Infarction
Timepoint [5] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [6] 0 0
Time to Any Ischemia-driven Arterial Revascularization
Timepoint [6] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [7] 0 0
Time to CHD Death
Timepoint [7] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [8] 0 0
Time to Cardiovascular Death
Timepoint [8] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [9] 0 0
Time to All Cause of Death
Timepoint [9] 0 0
From randomization; for approximately a median of 4.5 years
Secondary outcome [10] 0 0
Time to Ischemic Stroke
Timepoint [10] 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), 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
Sex
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 or atrial flutter not on anticoagulation therapy (vitamin K antagonist, heparin, low molecular weight heparin, fondaparinux,or non-Vitamin K antagonist oral anticoagulant)
* Triglycerides = 500 mg/dL (5.7 mmol/L) measured up to 3 months prior to screening. The most recent results must be used.
* 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/07/2025
Actual
Sample size
Target
Accrual to date
Final
12301
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [5] 0 0
Heartcare Partners - Auchenflower
Recruitment hospital [6] 0 0
Bundaberg Cardiology - Bundaberg
Recruitment hospital [7] 0 0
Holdsworth House Medical Brisbane - Fortitude Valley
Recruitment hospital [8] 0 0
Core Research Group Pty Ltd - Milton
Recruitment hospital [9] 0 0
Heart and Vascular Research - Adelaide
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
SA Heart - Ashford
Recruitment hospital [12] 0 0
Adelaide Cardiology Practice - Leabrook Clinic - Leabrook
Recruitment hospital [13] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [14] 0 0
HeartCare Victoria - Berwick - Berwick
Recruitment hospital [15] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [16] 0 0
The Cardiologists Proprietary Limited - Epping
Recruitment hospital [17] 0 0
Barwon Health Geelong Hospital - Geelong
Recruitment hospital [18] 0 0
GenesisCare Ringwood - Ringwood
Recruitment hospital [19] 0 0
Curtin University Centre of Clinical Research and Education - Bentley
Recruitment hospital [20] 0 0
HeartCare Western Australia - Joondalup - Joondalup
Recruitment hospital [21] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [22] 0 0
Dr Heart Pty Ltd - Woolloongabba
Recruitment postcode(s) [1] 0 0
2605 - Garran
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2050 - Camperdown
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2170 - Liverpool
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2035 - Maroubra
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4066 - Auchenflower
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4670 - Bundaberg
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4006 - Fortitude Valley
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4064 - Milton
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5000 - Adelaide
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5035 - Ashford
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5068 - Leabrook
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7000 - Hobart
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3806 - Berwick
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3168 - Clayton
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3076 - Epping
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3220 - Geelong
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3134 - Ringwood
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6102 - Bentley
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5068 - Joondalup
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6150 - Murdoch
Recruitment postcode(s) [21] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Dresden
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Germany
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Frankfurt am Main
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Germany
State/province [188] 0 0
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Germany
State/province [189] 0 0
Hamburg
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Germany
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Heidelberg
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Germany
State/province [191] 0 0
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Germany
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Leipzig
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Ulm
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Germany
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Villingen-Schwenningen
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Germany
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Witten
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Greece
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Hungary
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Baja
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Hungary
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Balatonfured
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Hungary
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Hungary
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Balloszog
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Hungary
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Bekescsaba
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Hungary
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Berettyoujfalu
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Hungary
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Budapest
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Hungary
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Hungary
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Eger
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Hungary
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Godollo
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Hungary
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Hungary
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Gyula
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Hungary
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Hatvan
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Sopron
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Netherlands
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Netherlands
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Poland
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Chrzanow
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Poland
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Gdansk
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Poland
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Poland
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Grodzisk Mazowiecki
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Portugal
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Romania
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Romania
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Romania
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Romania
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Romania
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Targu Mures
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Russian Federation
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Arkhangelsk
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Russian Federation
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Barnaul
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Russian Federation
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Ekaterinburg
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Russian Federation
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Russian Federation
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Russian Federation
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Kemerovo
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Russian Federation
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Kirov
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Russian Federation
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Omsk
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Russian Federation
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Perm
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Sait-Petersburg
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Sochi
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Russian Federation
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St. Petersburg
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Russian Federation
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Russian Federation
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Russian Federation
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Vladimir
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Russian Federation
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Slovakia
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Slovakia
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Slovakia
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Lucenec
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Slovakia
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Moldava nad Bodvou
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Slovakia
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Slovakia
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Slovakia
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Nove Zamky
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Slovakia
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Presov
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Slovakia
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Slovakia
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Snina
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Slovakia
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Svidnik
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Slovakia
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Slovakia
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Trencin
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Comunidad Valenciana
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Spain
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Galicia
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Spain
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Spain
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Spain
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Madrid
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Sweden
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Boras
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Sweden
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Falun
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Sweden
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Goteborg
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Sweden
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Harnosand
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Sweden
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Helsingborg
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Sweden
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Jonkoping
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Sweden
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Karlstad
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Sweden
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Lidkoping
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Sweden
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Lund
Country [429] 0 0
Sweden
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Malmo
Country [430] 0 0
Sweden
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Ostersund
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Sweden
State/province [431] 0 0
Stockholm
Country [432] 0 0
Sweden
State/province [432] 0 0
Umea
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Sweden
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Varberg
Country [434] 0 0
Taiwan
State/province [434] 0 0
Hualien
Country [435] 0 0
Taiwan
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Kaohsiung
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Taiwan
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New Taipei
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Taiwan
State/province [437] 0 0
Taichung
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Taiwan
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Taiwan
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Taipei
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Taiwan
State/province [440] 0 0
Taoyuan
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Ukraine
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Uzhgorod
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Ukraine
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Ukraine
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Ukraine
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United Kingdom
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United Kingdom
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United Kingdom
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Bath
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United Kingdom
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Belfast
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United Kingdom
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Bollington
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United Kingdom
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United Kingdom
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Bristol
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United Kingdom
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Burton upon Trent
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United Kingdom
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Chesterfield
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United Kingdom
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Cleveleys
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United Kingdom
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Corby
Country [459] 0 0
United Kingdom
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Coventry
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United Kingdom
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Crawley
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United Kingdom
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Dundee
Country [462] 0 0
United Kingdom
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Glasgow
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United Kingdom
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Hull
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United Kingdom
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United Kingdom
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Leamington Spa
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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Northwood
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United Kingdom
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United Kingdom
State/province [471] 0 0
Nuneaton
Country [472] 0 0
United Kingdom
State/province [472] 0 0
Orpington
Country [473] 0 0
United Kingdom
State/province [473] 0 0
Penzance
Country [474] 0 0
United Kingdom
State/province [474] 0 0
Peterborough
Country [475] 0 0
United Kingdom
State/province [475] 0 0
Poole
Country [476] 0 0
United Kingdom
State/province [476] 0 0
Romford
Country [477] 0 0
United Kingdom
State/province [477] 0 0
Sandbach
Country [478] 0 0
United Kingdom
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Scunthorpe
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United Kingdom
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Shipley
Country [480] 0 0
United Kingdom
State/province [480] 0 0
St Neots
Country [481] 0 0
United Kingdom
State/province [481] 0 0
Stamford
Country [482] 0 0
United Kingdom
State/province [482] 0 0
Stevenage
Country [483] 0 0
United Kingdom
State/province [483] 0 0
Swansea
Country [484] 0 0
United Kingdom
State/province [484] 0 0
Thetford
Country [485] 0 0
United Kingdom
State/province [485] 0 0
Torquay
Country [486] 0 0
United Kingdom
State/province [486] 0 0
Wakefield
Country [487] 0 0
United Kingdom
State/province [487] 0 0
Watford
Country [488] 0 0
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State/province [488] 0 0
West Bromwich
Country [489] 0 0
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State/province [489] 0 0
Whitby
Country [490] 0 0
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State/province [490] 0 0
Wokingham
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Worcester
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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/study/NCT03872401
Trial related presentations / publications
Bohula EA, Marston NA, Ruzza A, Murphy SA, De Ferrari GM, Diaz R, Leiter LA, Elliott-Davey M, Wang H, Bhatia AK, Giugliano RP, Sabatine MS. Rationale and design of the effect of evolocumab in patients at high cardiovascular risk without prior myocardial infarction or stroke (VESALIUS-CV) trial. Am Heart J. 2024 Mar;269:179-190. doi: 10.1016/j.ahj.2023.12.004. Epub 2023 Dec 29.
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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