Intravenous N-Acetylcysteine for the Treatment of Acute Ischemic Stroke
Status:
Not yet recruiting
Trial end date:
2023-03-25
Target enrollment:
Participant gender:
Summary
Stroke is a major cause of death and long-term disability in the developed world. While t-PA
and mechanical thrombectomy have been shown to decrease disability in properly selected
patients, many patients are left with lifelong symptoms. There are currently limited options
available for patients who are not candidates for treatment with t-PA and/or mechanical
thrombectomy.
N-Acetylcysteine (NAC) is an FDA approved antioxidant and anti-inflammatory agent that has
been used safely for many years in the treatment of acetaminophen overdose. In studies, the
oral form has been shown to improve outcomes in acute ischemic stroke and has been shown to
decrease the effects of ischemic brain injury in animal models. In a small human trial, it
improved outcomes in patients suffering from mild traumatic brain injury (TBI). The
intravenous formulation has a long safety record. It is not FDA approved for treating stroke
but was reviewed by the FDA and was given an FDA IND for this study.
The investigators propose a prospective randomized, double-blind, placebo-controlled study to
evaluate the efficacy of administering intravenous N-acetylcysteine to patients with acute
ischemic stroke. Eligible subjects will receive a commercially available form of intravenous
NAC (Acetadote®) through for the first 21 hours following their enrollment. Patients enrolled
who receive t-PA for thrombolysis will have their intravenous NAC infusion delayed for 24
hours after the completion of their t-PA infusion. Patients undergoing thrombectomy will be
excluded from enrollment. Subjects will be evaluated by emergency department and/or division
of neurology physicians at the time of enrollment, during their hospitalization, as well as
30 days and 90 days after enrollment. At each visit, subjects will be assessed for functional
status and quality of life.
This study is designed to compare the efficacy of intravenous N-acetylcysteine compared to
normal treatment in patients with acute ischemic stroke.
Phase:
Phase 2
Details
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center