PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis — PINNACLE  

Stroke Clinical Trial

Official title: PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Atherosclerosis
• Hemorrhage
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Intraplaque Hemorrhage
• Stroke

• NCT number: NCT03507374
• Study type: Interventional
• Source: University of Utah
• Status: Terminated
• Phase: Early Phase 1
• Start date: October 30, 2018
• Completion date: April 17, 2020