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NCT00585559 · ClinicalTrials.gov registry record · Phase 3
Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm
A Phase 3 study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT00585559: Clinical Trial Phase 3 study, sponsored by Vanderbilt University Medical Center.
NCT00585559 is a Phase 3 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 44 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00585559, a Phase 3 study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study Summary
The objective of this study is to determine whether acetaminophen (APAP), N-acetylcysteine (NAC), and APAP in combination with NAC will inhibit lipid peroxidation in aneurysmal subarachnoid hemorrhage (aSAH), utilizing F2-IsoPs as biomarkers for lipid peroxidation.
Primary Outcome
Presence of vasospasm measured Magnetic Resonance Angiography (MRA). MRA measures the degree of arterial narrowing, with a higher score indicating more severe vasospasm. An MRA score of 84% sensitivity and 72% specificity is indicative of vasospasm.
Interventions
- DRUG Placebos for acetaminophen and N-acetylcysteine
- DRUG APAP 1 gm every 6 hours and N-acetylcysteine placebo
- DRUG NAC IV infusion at 0.5 gm hourly and APAP placebo
- DRUG APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly
- DRUG APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2007-04 |
| Est. Completion | 2023-10-26 |
| Phase | Phase 3 |
Why NCT00585559 stopped before completion
NCT00585559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebos for acetaminophen and N-acetylcysteine is the first listed.
NCT00585559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00585559 about?
NCT00585559 is a clinical study titled "Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm". The objective of this study is to determine whether acetaminophen (APAP), N-acetylcysteine (NAC), and APAP in combination with NAC will inhibit lipid peroxidation in aneurysmal subarachnoid hemorrhage (aSAH), utilizing F2-IsoPs as biomarkers for lipid peroxidation.
What is the current status of trial NCT00585559?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2007-04. Estimated completion is 2023-10-26.
What interventions are being tested in trial NCT00585559?
The interventions under investigation include: Placebos for acetaminophen and N-acetylcysteine (DRUG), APAP 1 gm every 6 hours and N-acetylcysteine placebo (DRUG), NAC IV infusion at 0.5 gm hourly and APAP placebo (DRUG), APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly (DRUG), APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly (DRUG).
Who is sponsoring clinical trial NCT00585559?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00585559's enrollment target sits among peer trials
44 1874th of 2000 higher than 125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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