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Reducing Intracranial atheroSclErosis With Repatha (RISER)

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ClinicalTrials.gov Identifier: NCT04573777
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : April 27, 2021
Sponsor:
Collaborators:
Adam de Havenon
Amgen
Information provided by (Responsible Party):
David Liebeskind, University of California, Los Angeles

Brief Summary:
The purpose of this study will be to understand the underlying mechanism by which PCSK9 inhibition reduces the rate of ischemic stroke seen in the pivotal studies that led to its FDA approval for ASCVD such as ischemic stroke. Those trials (FOURIER and ODYSSEY) enrolled almost 50,000 patients and showed that PCSK9 inhibition therapy is safe and effective. The investigators hypothesize that PCSK9 inhibition lowers the rate of stroke by reducing atherosclerotic plaque, which would be particularly beneficial for patients with intracranial atherosclerosis, who have the highest rate of recurrent stroke of any stroke mechanism.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Repatha Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Intracranial atheroSclErosis With Repatha
Actual Study Start Date : April 23, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
Drug Information available for: Evolocumab

Arm Intervention/treatment
Experimental: Intervention Repatha Drug: Repatha
140 MG in 1 ML Prefilled Syringe PCSK9 Inhibitor




Primary Outcome Measures :
  1. Stenosis [ Time Frame: 1.5 years ]
    Measured on ToF MRA, CE-MRA, T1 Dante


Secondary Outcome Measures :
  1. Percent atheroma volume [ Time Frame: 1.5 years ]
    Measured on ToF MRA, CE-MRA, T1/T2/PD Dante


Other Outcome Measures:
  1. Ischemic Stroke [ Time Frame: 1.5 years ]
    Adjudicated

  2. ITA [ Time Frame: 1.5 years ]
    Adjudicated



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, ≥ 18 years of age
  • History of ischemic stroke, defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction (American Heart Association definition).
  • Large vessel atherosclerosis of an intracranial artery in the circle of Willis with 50-99% stenosis by WASID criteria (percent stenosis = (1-[diameter stenosis/diameter normal]) x 100%) on MRA, CTA or DSA

    ------ Eligible arteries: vertebral (V4), basilar, PCA (P1, P2), MCA (M1, M2), tICA, ACA (A1)

  • Current statin use or contraindication to statin
  • Fasting LDL-C ≥ 70 mg/dL or LDL-C ≥ 60 mg/dL if lipoprotein (a) > 30 mg/ dL

Exclusion Criteria:

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 guidelines
  • Inability to return for 78 week follow-up clinic visit and vwMRI

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): NCT04573777


Contacts
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Contact: David Liebeskind, M.D. 310-963-5539 dliebeskind@mednet.ucla.edu

Locations
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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: David Liebeskind, MD    310-963-5539    dliebeskind@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Adam de Havenon
Amgen
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Responsible Party: David Liebeskind, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04573777    
Obsolete Identifiers: NCT04573010
Other Study ID Numbers: 00121763
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by David Liebeskind, University of California, Los Angeles:
Intracranial Atherosclerosis
Additional relevant MeSH terms:
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Ischemic Stroke
Intracranial Arteriosclerosis
Atherosclerosis
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Intracranial Arterial Diseases
Evolocumab
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents