Reducing Intracranial atheroSclErosis With Repatha (RISER)

University of California, Los Angeles (UCLA)

Status and phase

Terminated

Phase 4

Conditions

Ischemic Stroke

Treatments

Drug: Repatha

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04573777

00121763

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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