Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2
Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
This trial will be a phase 2 randomized safety study in which ischemic stroke patients will
be randomly assigned within 24 hours of symptom onset to placebo or standard dose lovastatin
versus short-term high-dose lovastatin 640 mg per day for 3 days. The primary outcome of this
Phase 2 study will be musculoskeletal and hepatic toxicity, defined by clinical and
laboratory criteria, with a 3-month follow-up period (± 1 week). Secondary outcomes will
include neurological outcome (National Institute of Health (NIH) Stroke Scale), functional
outcomes (Barthel Index), and handicap (modified Rankin scores). Effects on inflammatory
markers and lipid levels will also be assessed.
Phase:
Phase 2
Details
Lead Sponsor:
Mitchell S Elkind
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)