PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

• Status: Terminated
• Trial end date: 2020-04-17
• Target enrollment: 0
• Participant gender: All

Summary

This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and intracranial atherosclerotic disease are randomized to either drug or placebo.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Adult patients, ≥ 18 years of age

• Ischemic stroke (≤ 1 month from onset) in one major vascular territory on diffusion-weighted MRI

• ICAD plaque of a "major intracranial artery," causing >25% and <99% stenosis

• Eligible arteries: vertebral (V4), basilar, PCA (P1, P2), MCA (M1, M2), terminal ICA, and ACA (A1)

• Able to tolerate high-dose statin (atorvastatin 40-80 mg)

Exclusion Criteria:

• Stroke mechanism other than ICAD, including history of atrial fibrillation, hypercoagulability, ipsilateral arterial dissection or carotid stenosis >50%, and rare causes of stroke such as vasculitis or CADASIL

• Bihemispheric stroke or simultaneous stroke in the anterior and posterior circulation

• Positive pregnancy test

• 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 guidelines33

• Inability to return for 1-year follow-up clinic visit and vwMRI