PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

Stopped early · Early Phase 1 · Has a placebo group

Conditions studied: Stroke, Intracranial Atherosclerosis, Intraplaque Hemorrhage

In brief

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.

Key facts

Study ID

NCT03507374

Run by

University of Utah

People needed

20

Starts

2018-10-30

Expected to finish

2020-04-17

Last updated by the study team

2020-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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