Reducing Intracranial atheroSclErosis With Repatha

NCT ID: NCT04573777

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2021-12-16

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Repatha

Group Type: EXPERIMENTAL

Repatha

Intervention Type: DRUG

140 MG in 1 ML Prefilled Syringe PCSK9 Inhibitor

Interventions

Repatha

140 MG in 1 ML Prefilled Syringe PCSK9 Inhibitor

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

David Liebeskind

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCLA

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

00121763

Identifier Type: -

Identifier Source: org_study_id

NCT04573010

Identifier Type: -

Identifier Source: nct_alias