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PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

NCT03507374 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-04-21

No results posted yet for this study

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.

Conditions

  • Stroke
  • Intracranial Atherosclerosis
  • Intraplaque Hemorrhage

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Adam de Havenon, MD · University of Utah

  • Scott McNally, MD, PhD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2020-04-17
Completion
2020-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507374 on ClinicalTrials.gov