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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

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
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Royal Prince Alfred Hospital - Camperdown
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Liverpool Hospital - Liverpool
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Australian Clinical Research Network - Maroubra
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Heartcare Partners - Auchenflower
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Bundaberg Cardiology - Bundaberg
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Holdsworth House Medical Brisbane - Fortitude Valley
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Core Research Group Pty Ltd - Milton
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Heart and Vascular Research - Adelaide
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Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
SA Heart - Ashford
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Adelaide Cardiology Practice - Leabrook Clinic - Leabrook
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Royal Hobart Hospital - Hobart
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HeartCare Victoria - Berwick - Berwick
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Monash Medical Centre - Clayton
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The Cardiologists Proprietary Limited - Epping
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Barwon Health Geelong Hospital - Geelong
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GenesisCare Ringwood - Ringwood
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Curtin University Centre of Clinical Research and Education - Bentley
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HeartCare Western Australia - Joondalup - Joondalup
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Fiona Stanley Hospital - Murdoch
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Dr Heart Pty Ltd - Woolloongabba
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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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4102 - Woolloongabba
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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
State/province [190] 0 0
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
State/province [193] 0 0
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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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Larissa
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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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Balatonkeresztur
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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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Debrecen
Country [220] 0 0
Hungary
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Eger
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Hungary
State/province [221] 0 0
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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Italy
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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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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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Mexico
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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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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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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Plock
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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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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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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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Samara
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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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Tyumen
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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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Castilla León
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Spain
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Cataluña
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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
Country [428] 0 0
Sweden
State/province [428] 0 0
Lund
Country [429] 0 0
Sweden
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Malmo
Country [430] 0 0
Sweden
State/province [430] 0 0
Ostersund
Country [431] 0 0
Sweden
State/province [431] 0 0
Stockholm
Country [432] 0 0
Sweden
State/province [432] 0 0
Umea
Country [433] 0 0
Sweden
State/province [433] 0 0
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
State/province [436] 0 0
New Taipei
Country [437] 0 0
Taiwan
State/province [437] 0 0
Taichung
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Taiwan
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Taiwan
State/province [439] 0 0
Taipei
Country [440] 0 0
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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Kyiv
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Ukraine
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Uzhgorod
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Ukraine
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Ukraine
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Vinnytsya
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Ukraine
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Zaporizhzhia
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United Kingdom
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United Kingdom
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Barnsley
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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
Country [458] 0 0
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
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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
State/province [478] 0 0
Scunthorpe
Country [479] 0 0
United Kingdom
State/province [479] 0 0
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
United Kingdom
State/province [488] 0 0
West Bromwich
Country [489] 0 0
United Kingdom
State/province [489] 0 0
Whitby
Country [490] 0 0
United Kingdom
State/province [490] 0 0
Wokingham
Country [491] 0 0
United Kingdom
State/province [491] 0 0
Worcester
Country [492] 0 0
United Kingdom
State/province [492] 0 0
Yeovil

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) The product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03872401