Overview

Intravenous N-Acetylcysteine for the Treatment of Acute Ischemic Stroke

Status:
Not yet recruiting

Trial end date:
2023-03-25

Target enrollment:
0

Participant gender:
All

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

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Treatments:

Acetylcysteine
N-monoacetylcystine

Criteria

Inclusion Criteria:

- Consecutive subjects between ages 18 years or older evaluated in the emergency
department at Harbor-UCLA Medical Center with signs and symptoms of acute ischemic
stroke presenting within 24 hours of symptom onset. All individuals regardless of
gender or race will be included. For adults who cannot consent for themselves because
of the severity of their stroke, one of the investigators will offer participation in
the study to the family member who possesses the authority for medical decision making
for the patient. There is no financial incentive for either the patient or the
investigator. It will also be explained that the potential benefit of giving
N-acetylcysteine is unknown and that the patient will receive excellent care (standard
for their presentation) whether they participate or not and outside of not receiving
the study drug.

Our patients tend to be economically disadvantaged but since there are no financial
incentives either for the patient or for the investigators, this bias has been minimized.
Patients will receive the same care whether they participate in the study or decline.

Exclusion Criteria:

- Evidence of hemorrhagic stroke on initial CT scan

- Need for thrombectomy as determined by the treating neurologist -Known allergy to NAC

- Protected populations, including age < 18, known pregnancy, and prisoners

- Patients who are DNR/DNI at the time of presentation with a short life expectancy