RISER: Reducing Intracranial atheroSclErosis With Repatha

Sponsor

University of California, Los Angeles (Other)

Overall Status

Terminated

CT.gov ID

NCT04573777

Collaborator

Amgen (Industry)

Enrollment

Location

Arm

7.8

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Drug: Repatha	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

12 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 :

Apr 23, 2021

Actual Primary Completion Date :

Dec 16, 2021

Actual Study Completion Date :

Dec 16, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention Repatha

Drug: Repatha

140 MG in 1 ML Prefilled Syringe PCSK9 Inhibitor

Outcome Measures

Primary Outcome Measures

Stenosis [1.5 years]
Measured on ToF MRA, CE-MRA, T1 Dante

Secondary Outcome Measures

Percent atheroma volume [1.5 years]
Measured on ToF MRA, CE-MRA, T1/T2/PD Dante

Other Outcome Measures

Ischemic Stroke [1.5 years]
Adjudicated
ITA [1.5 years]
Adjudicated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095

Sponsors and Collaborators

University of California, Los Angeles
Amgen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Liebeskind, Principal Investigator, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT04573777

Other Study ID Numbers:

00121763
NCT04573010

First Posted:

Oct 5, 2020

Last Update Posted:

Feb 1, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by David Liebeskind, Principal Investigator, University of California, Los Angeles

Intracranial Atherosclerosis

Additional relevant MeSH terms:

Ischemic Stroke

Intracranial Arteriosclerosis

Atherosclerosis

Evolocumab

Study Results

No Results Posted as of Feb 1, 2022