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Reducing Intracranial atheroSclErosis With Repatha (RISER)

Primary Purpose

Ischemic Stroke

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Repatha
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Intracranial Atherosclerosis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Repatha

Arm Description

Outcomes

Primary Outcome Measures

Stenosis
Measured on ToF MRA, CE-MRA, T1 Dante

Secondary Outcome Measures

Percent Atheroma Volume
Measured on ToF MRA, CE-MRA, T1/T2/PD Dante

Full Information

First Posted
September 28, 2020
Last Updated
February 16, 2023
Sponsor
University of California, Los Angeles
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04573777
Brief Title
Reducing Intracranial atheroSclErosis With Repatha
Acronym
RISER
Official Title
Reducing Intracranial atheroSclErosis With Repatha
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Funding Discontinued
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
December 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Amgen

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Intracranial Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Repatha
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Repatha
Intervention Description
140 MG in 1 ML Prefilled Syringe PCSK9 Inhibitor
Primary Outcome Measure Information:
Title
Stenosis
Description
Measured on ToF MRA, CE-MRA, T1 Dante
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
Percent Atheroma Volume
Description
Measured on ToF MRA, CE-MRA, T1/T2/PD Dante
Time Frame
1.5 years
Other Pre-specified Outcome Measures:
Title
Ischemic Stroke
Description
Adjudicated
Time Frame
1.5 years
Title
ITA
Description
Adjudicated
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reducing Intracranial atheroSclErosis With Repatha

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