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

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ClinicalTrials.gov Identifier: NCT03872401
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease (CHD) Drug: Evolocumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : June 20, 2025
Estimated Study Completion Date : June 20, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W) for a minimum of 4 years.
 Drug: Placebo
Administered subcutaneously using an autoinjector pen.
Experimental: Evolocumab 140 mg Q2W
Participants will receive 140 mg evolocumab by subcutaneous injection once every 2 weeks for a minimum of 4 years.
 Drug: Evolocumab
Administered subcutaneously using an autoinjector pen.
Other Names:
  • AMG 145
  • Repatha


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Time to MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  2. Time to CHD Death, MI, or Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  3. Time to Cardiovascular Death, MI, or Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  4. Time to Myocardial Infarction [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  5. Time to Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  6. Time to CHD Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  7. Time to Cardiovascular Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  8. Time to All Cause of Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
  9. Time to Ischemic Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872401


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03872401    
Other Study ID Numbers: 20170625
2018-004565-14 ( EudraCT Number )
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
High Cardiovascular Risk
No prior Myocardial Infarction stroke
>= 50 years of age (men)
>= 55 years of age (women)
lipid-lowering therapy
Additional relevant MeSH terms:
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Myocardial Infarction
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Infarction
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
 Necrosis
Arteriosclerosis
Arterial Occlusive Diseases
Evolocumab
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents