PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis
NCT ID: NCT03507374
Last Updated: 2020-04-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
EARLY_PHASE1
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-10-30
Study Completion Date
2020-04-17
Brief Summary
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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.
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Detailed Description
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The purpose of this study will be a dataset that lays the foundation for a randomized controlled trial of PCSK9 inhibition in intracranial atherosclerotic disease (ICAD) patients, designed to show a reduction in the primary endpoint of ischemic stroke recurrence. Such a trial would provide evidence for the utility of alirocumab to prevent recurrent stroke in ICAD. While we are proposing future studies to reduce recurrent ICAD stroke risk, it should be noted that, in the long term, our research may lead to effective primary ICAD stroke risk reduction through PCSK9 inhibition in patients at high risk of stroke identified through asymptomatic stenosis, post-contrast plaque enhancement (PPE) or intraplaque hemorrhage (IPH) on vwMRI.
Conditions
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Stroke
Intracranial Atherosclerosis
Intraplaque Hemorrhage
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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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.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo to be administered subcutaneously every 2 weeks identical to active drug (alirocumab)
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
Group Type
ACTIVE_COMPARATOR
Alirocumab
Intervention Type
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.
Interventions
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Alirocumab
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.
Intervention Type
DRUG
Placebo
Placebo to be administered subcutaneously every 2 weeks identical to active drug (alirocumab)
Intervention Type
DRUG
Other Intervention Names
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Praluent
Eligibility Criteria
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Inclusion Criteria
* Adult patients, ≥ 18 years of age
* Ischemic stroke (≤ 1 month from onset) in one major vascular territory on diffusion-weighted MRI
* ICAD plaque of a "major intracranial artery," causing \>25% and \<99% stenosis
* Eligible arteries: vertebral (V4), basilar, PCA (P1, P2), MCA (M1, M2), terminal ICA, and ACA (A1)
* Able to tolerate high-dose statin (atorvastatin 40-80 mg)
* Ischemic stroke (≤ 1 month from onset) in one major vascular territory on diffusion-weighted MRI
* ICAD plaque of a "major intracranial artery," causing \>25% and \<99% stenosis
* Eligible arteries: vertebral (V4), basilar, PCA (P1, P2), MCA (M1, M2), terminal ICA, and ACA (A1)
* Able to tolerate high-dose statin (atorvastatin 40-80 mg)
Exclusion Criteria
* Stroke mechanism other than ICAD, including history of atrial fibrillation, hypercoagulability, ipsilateral arterial dissection or carotid stenosis \>50%, and rare causes of stroke such as vasculitis or CADASIL
* Bihemispheric stroke or simultaneous stroke in the anterior and posterior circulation
* Positive pregnancy test
* Gadolinium or PCSK9 inhibitor allergy
* Acute or chronic kidney disease with eGFR\<30 ml/min/1.73m2
* Pacemaker or other MRI contraindications per American College of Radiology guidelines33
* Inability to return for 1-year follow-up clinic visit and vwMRI
* Bihemispheric stroke or simultaneous stroke in the anterior and posterior circulation
* Positive pregnancy test
* Gadolinium or PCSK9 inhibitor allergy
* Acute or chronic kidney disease with eGFR\<30 ml/min/1.73m2
* Pacemaker or other MRI contraindications per American College of Radiology guidelines33
* Inability to return for 1-year follow-up clinic visit and vwMRI
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sponsor Role
collaborator
University of Utah
OTHER
Sponsor Role
lead
Responsible Party
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Adam de Havenon
MD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Adam de Havenon, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Scott McNally, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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University of Utah
Salt Lake City, Utah, United States
Site Status
Countries
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United States
References
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Other Identifiers
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00104839
Identifier Type: -
Identifier Source: org_study_id
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