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Reducing Intracranial atheroSclErosis With Repatha (RISER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04573777
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : April 27, 2021
Adam de Havenon
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 ]

  2. ITA [ Time Frame: 1.5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT04573777

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Contact: David Liebeskind, M.D. 310-963-5539

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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: David Liebeskind, MD    310-963-5539   
Sponsors and Collaborators
University of California, Los Angeles
Adam de Havenon
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Responsible Party: David Liebeskind, Principal Investigator, University of California, Los Angeles 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
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Intracranial Arterial Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents