Trial Outcomes & Findings for Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm (NCT NCT00585559)
NCT ID: NCT00585559
Last Updated: 2025-04-18
Results Overview
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.
TERMINATED
PHASE3
44 participants
8 Days post subarachnoid hemorrhage (SAH) event
2025-04-18
Participant Flow
Participant milestones
| Measure |
N-acetylcysteine IV Infusion at 0.5 gm Hourly
N-acetylcysteine IV infusion at 0.5 gm hourly
|
Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly
Placebo for N-acetylcysteine IV infusion at 0.5 gm hourly
|
Acetaminophen Plus N-acetylcysteine Infusion
Acetaminophen 1.5gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
11
|
|
Overall Study
COMPLETED
|
16
|
17
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm
Baseline characteristics by cohort
| Measure |
N-acetylcysteine IV Infusion at 0.5 gm Hourly
n=16 Participants
N-acetylcysteine IV infusion at 0.5 gm hourly
|
Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly
n=17 Participants
Placebo for N-acetylcysteine IV infusion at 0.5 gm hourly
|
Aacetaminophen and N-acetylcysteine Infusion
n=11 Participants
Acetaminophen 1.5gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
11 participants
n=5 Participants
|
44 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) eventPopulation: No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) eventPopulation: No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study.
Presence of vasospasm measured by Computed Tomographic Angiography (CTA). CTA scores range from 0 (no vasospasm) to 34, where a score of 10 or more is indicative of vasospasm.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) eventPopulation: No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study.
The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairments related to stroke. The impairments are graded on a 3-4 point scale with scores that range from 0-42. Patients with a higher score have a more severe impairment, and patients with a lower score have a less severe impairment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) eventPopulation: No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study.
The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The 7 point ordinal scale ranges from No symptoms (0) to Death (6), with higher scores representing worse outcome.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) eventPopulation: No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study.
The Glasgow Outcome Scale (GOS) is a scale used to assess recovery of participants with brain damage. The scale has 5 categories: Death (1), Persistent vegetative state (2), Severe disability (3), Moderate disability (4), Good recovery (5).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) eventPopulation: No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study.
The Barthel index measures the extent to which someone can function independently during basic activities of daily living. Scores range from (from 0 to 100), 0 meaning disability and 100 meaning independence, therefore, higher score, better outcome.
Outcome measures
Outcome data not reported
Adverse Events
N-acetylcysteine IV Infusion at 0.5 gm Hourly
Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly
Acetaminophen Plus N-acetylcysteine IV Infusion
Serious adverse events
| Measure |
N-acetylcysteine IV Infusion at 0.5 gm Hourly
n=16 participants at risk
N-acetylcysteine IV infusion at 0.5 gm hourly
|
Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly
n=17 participants at risk
Placebo for N-acetylcysteine IV infusion at 0.5 gm hourly
|
Acetaminophen Plus N-acetylcysteine IV Infusion
n=11 participants at risk
Acetaminophen 1.5gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
|
|---|---|---|---|
|
Nervous system disorders
Vasospasm
|
0.00%
0/16 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
11.8%
2/17 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
9.1%
1/11 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/16 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
5.9%
1/17 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/11 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
|
General disorders
Death
|
6.2%
1/16 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
11.8%
2/17 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/11 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
|
Nervous system disorders
Ischemic Stroke
|
0.00%
0/16 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/17 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
9.1%
1/11 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
Other adverse events
| Measure |
N-acetylcysteine IV Infusion at 0.5 gm Hourly
n=16 participants at risk
N-acetylcysteine IV infusion at 0.5 gm hourly
|
Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly
n=17 participants at risk
Placebo for N-acetylcysteine IV infusion at 0.5 gm hourly
|
Acetaminophen Plus N-acetylcysteine IV Infusion
n=11 participants at risk
Acetaminophen 1.5gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/17 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/11 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
5.9%
1/17 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/11 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/17 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
9.1%
1/11 • Baseline to 21 days
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place