Reducing Intracranial atheroSclErosis With Repatha

NCT04573777 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 00121763
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Intracranial Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Stenosis

  Measured on ToF MRA, CE-MRA, T1 Dante

  1.5 years

Secondary Outcomes (1)

• Percent Atheroma Volume

  1.5 years

Other Outcomes (2)

• Ischemic Stroke

  1.5 years

• ITA

  1.5 years

Study Arms (1)

Intervention Repatha

EXPERIMENTAL

Drug: Repatha

Interventions

Repatha DRUG

140 MG in 1 ML Prefilled Syringe PCSK9 Inhibitor

Intervention Repatha

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Amgen: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Arteriosclerosis

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: David Liebeskind
• Organization: UCaliforniaLA

dliebeskind@mednet.ucla.edu

‭(310) 963-5539‬

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: April 23, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: March 15, 2023
• Results First Posted: March 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)