PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT03507374
Phase
EARLY_PHASE1
Status
Terminated

Conditions

  • Intracranial Atherosclerosis
  • Intraplaque Hemorrhage
  • Stroke

Eligibility Criteria

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

Interventions

  • Alirocumab — DRUG
    Alirocumab is approved by the FDA as a secondary treatment for high cholesterol for adults whose cholesterol can not be controlled by diet and/or statin treatment. Additionally, Alirocumab works to inhibit the PCSK9 protein.
  • Placebo — DRUG
    Placebo to be administered subcutaneously every 2 weeks identical to active drug (alirocumab)

Study Details

This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and intracranial atherosclerotic disease are randomized to either drug or placebo.

Key Dates

Start date
Oct 30, 2018
Status verified
Apr 2020
Primary completion
Apr 17, 2020
Completion
Apr 17, 2020

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Comparator
    After review of eligibility criteria, 20 patients will be randomized to the placebo arm of the study where patient will administer one subcutaneous injection of placebo every two weeks for a total of 52 weeks. Additionally, per standard-of-care, patient will also be treated with atorvastatin 40-80 mg.
  • Active Comparator: Active Comparator
    After review of eligibility criteria, 20 patients will be randomized to receive the investigational treatment of alirocumab 150mg which will be administered subcutaneously with a single-dose pre-filled pen syringe every 2 weeks for a total of 52 weeks. Additionally, per standard-of-care, patient will also be treated with atorvastatin 40-80 mg

Primary Outcome Measure

Vessel Wall MRI [ Time Frame: Day 1 and Day 365 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84132-

Find similar trials in Salt Lake City, UT

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Utah· Salt Lake City, UT

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