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NCT04918719 · ClinicalTrials.gov registry record · Phase 2
Intravenous N-Acetylcysteine for the Treatment of Acute Ischemic Stroke
A Phase 2 study, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT04918719 is a Phase 2 study that has completed, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 4 participants.
The verdict
NCT04918719, a Phase 2 study, has completed, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study 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 20 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.
Interventions
- DRUG Acetylcysteine
- DRUG Dextrose in Water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-11-02 |
| Est. Completion | 2024-09-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04918719
The ClinicalTrials.gov registry entry for NCT04918719 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Acetylcysteine is the first listed.
NCT04918719 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04918719 about?
NCT04918719 is a clinical study titled "Intravenous N-Acetylcysteine for the Treatment of Acute Ischemic Stroke". 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...
What is the current status of trial NCT04918719?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2023-11-02. Estimated completion is 2024-09-17.
What interventions are being tested in trial NCT04918719?
The interventions under investigation include: Acetylcysteine (DRUG), Dextrose in Water (DRUG).
Who is sponsoring clinical trial NCT04918719?
This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
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