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Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03872401
Recruitment Status : Active, not recruiting
First Posted : March 13, 2019
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date December 7, 2021
Actual Study Start Date  ICMJE June 11, 2019
Estimated Primary Completion Date May 26, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Time to Coronary Heart Disease Death, Myocardial Infarction, or Ischemic Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]
    Time to coronary heart disease (CHD) death, myocardial infarction (MI), or ischemic stroke, whichever occurs first.
  • Time to Coronary Heart Disease Death, Myocardial Infarction, Ischemic Stroke, or Any Ischemia-driven Arterial Sroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]
    Time to CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first.
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
Time to Coronary heart disease (CHD) death, Myocardial Infarction, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first [ Time Frame: Start at the beginning of the study until end of study (EOS) or 30(+3) days after the last dose of Investigational Product, a minimum of 4 years (anticipated median around 4.5 years). ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Time to MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  • Time to CHD Death, MI, or Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  • Time to Cardiovascular Death, MI, or Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  • Time to Myocardial Infarction [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  • Time to Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  • Time to CHD Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  • Time to Cardiovascular Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  • Time to All Cause of Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  • Time to Ischemic Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
Time to Coronary Heart Disease (CHD) death, cardiovascular death, Myocardial Infarction, stroke, ischemic stroke or any ischemia-driven arterial revascularization, all cause of death. [ Time Frame: Start at the beginning of the study until end of study (EOS) or 30(+3) days after the last dose of Investigational Product, a minimum of 4 years (anticipated median around 4.5 years). ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 11, 2019)
  • Subject incidence of treatment-emergent adverse events leading to investigational product discontinuation. [ Time Frame: Start at the beginning of the study until end of study (EOS) or 30(+3) days after the last dose of Investigational Product, a minimum of 4 years (anticipated median around 4.5 years). ]
    Adverse events leading to investigational product discontinuation.
  • Subject incidence of treatment-emergent serious adverse events. [ Time Frame: Start at the beginning of the study until end of study (EOS) or 30(+3) days after the last dose of Investigational Product, a minimum of 4 years (anticipated median around 4.5 years). ]
    Serious adverse events leading to investigational product discontinuation.
 
Descriptive Information
Brief Title  ICMJE Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Heart Disease (CHD)
Intervention  ICMJE
  • Drug: Evolocumab
    Administered subcutaneously using an autoinjector pen.
    Other Names:
    • AMG 145
    • Repatha
  • Drug: Placebo
    Administered subcutaneously using an autoinjector pen.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W) for a minimum of 4 years.
    Intervention: Drug: Placebo
  • Experimental: Evolocumab 140 mg Q2W
    Participants will receive 140 mg evolocumab by subcutaneous injection once every 2 weeks for a minimum of 4 years.
    Intervention: Drug: Evolocumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 3, 2021)
12301
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2019)
13000
Estimated Study Completion Date  ICMJE May 26, 2025
Estimated Primary Completion Date May 26, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Czechia,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hungary,   Iceland,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03872401
Other Study ID Numbers  ICMJE 20170625
2018-004565-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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.
URL: http://www.amgen.com/datasharing
Current Responsible Party Amgen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Amgen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP