A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy

Sponsor
Canadian Medical and Surgical Knowledge Translation Research Group
Study ID
NCT04539223
Phase
PHASE4
Status
Unknown

Conditions

  • Asymptomatic Carotid Artery Stenosis
  • Carotid Artery Stenosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Autoinjector 1-mL deliverable volume of 140 mg/mL

Study Details

This is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive LDL-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques.

Key Dates

Start date
Aug 28, 2020
Status verified
Apr 2022
Primary completion
Apr 30, 2022
Completion
May 31, 2022

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Drug (Evolocumab)
    Individuals randomized to this arm will administer Evolocumab subcutaneously (SC) every two weeks (Q2W) for 26 weeks.
  • No Intervention: No Drug (Standard of Care)
    Individuals randomized to this arm will not administer a placebo.

Primary Outcome Measure

Change in lipid rich necrotic core (LRNC) volume [ Time Frame: Baseline to end of treatment (average of 6 months) ]

Central Contacts

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