NCT03507374

PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study will be a dataset that lays the foundation for a randomized controlled trial of PCSK9 inhibition in intracranial atherosclerotic disease (ICAD) patients, designed to show a reduction in the primary endpoint of ischemic stroke recurrence. Such a trial would provide evidence for the utility of alirocumab to prevent recurrent stroke in ICAD. While we are proposing future studies to reduce recurrent ICAD stroke risk, it should be noted that, in the long term, our research may lead to effective primary ICAD stroke risk reduction through PCSK9 inhibition in patients at high risk of stroke identified through asymptomatic stenosis, post-contrast plaque enhancement (PPE) or intraplaque hemorrhage (IPH) on vwMRI.

Conditions

• Stroke
• Intracranial Atherosclerosis
• Intraplaque Hemorrhage

Interventions

Type	Name	Description
DRUG	Alirocumab	Alirocumab is approved by the FDA as a secondary treatment for high cholesterol for adults whose cholesterol can not be controlled by diet and/or statin treatment. Additionally, Alirocumab works to inhibit the PCSK9 protein.
DRUG	Placebo	Placebo to be administered subcutaneously every 2 weeks identical to active drug (alirocumab)

Timeline

• Start date: 2018-10-30
• Primary completion: 2020-04-17
• Completion: 2020-04-17
• First posted: 2018-04-25
• Last updated: 2020-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study