Aneurysmal Subarachnoid HemorrhagePhase 3NCT00585559
Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm
A Phase 3 study testing APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly and APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly in people with Aneurysmal Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm
- What is being tested?
- APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly and APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to 26 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages ≥ 20
- Fisher Grade III or III + IV SAH based upon admitting CT scan
- Aneurysm secured by either clipping or coiling within 72 hours of SAH
- Intracranial aneurysm confirmed by angiography or CTA
- Presence of ventriculostomy for external ventricular drainage (EVD) prior to randomization
Who cannot join
- Consent unobtainable
- Enrollment in another interventional study
- Patient is pregnant or lactating
- Known co-morbidities that could affect outcome of this study
- Contraindication to CTA
- Serum creatinine > 1.4
Show all 19Show fewer
- Documented allergy to iodinated contrast that cannot be adequately treated with premedication
- Documented allergy and/or intolerance to ApAP
- Baseline liver disease
- History of recent alcohol abuse with documented ALT or AST above normal laboratory values
- Documented history of both malnutrition and decreased serum albumin below normal lab values
- Documented abnormal platelet count below normal lab values
- Documented abnormal PT or PTT above normal lab values
- History or evidence of active asthma
- Documented allergy and/or intolerance to N-acetylcysteine
- Currently taking phenytoin, carbamazepine, or phenobarbital
- Currently taking isoniazid (INH, Lanzid, Nydrazid)
- Severe life-threatening complications resulting from standard aneurysm treatments that will likely prevent completion of the study
- Patient unsuitable for the study, in the opinion of the investigator(s)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Inhibition of Lipid Peroxidation and Cerebral Vasospasm by an Acetaminophen-Based Regimen in Patients With Aneurysmal Subarachnoid Hemorrhage
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.
Read the detailed description
Aneurysmal subarachnoid hemorrhage (aSAH) is an often devastating form of stroke with high morbidity and mortality despite advances in surgical management. Approximately 30,000 patients annually suffer aSAH in the U.S. For patients who survive the initial subarachnoid hemorrhage, delayed cerebral vasospasm occurring from days 4-14 is the greatest cause of neurological disability and death. A growing body of evidence incriminates hemoprotein-catalyzed lipid peroxidation as the mediator of the vasospasm.
Hemoglobin released from lysed red cells in the subarachnoid space becomes oxidized, in which state it acts as a pseudoperoxidase and generates the protein radicals that induce lipid peroxidation. F2-isoprostanes formed by this lipid peroxidation are highly potent constrictors of cerebral arterioles. We have demonstrated a more than 5 fold mean increase in F2-isoprostanes in the cerebrospinal fluid of patients with aSAH; this increase is maximal at the time of delayed vasospasm, and the level of increase is a function of the severity of the aSAH. We hypothesize that such vasoconstrictors are major contributors to the vasospasm produced by the hemoproteins, hemoglobin and myoglobin, in diseases in which they are released from their cellular confines.
We have discovered that acetaminophen (APAP) is a potent inhibitor of hemoprotein-catalyzed lipid peroxidation with an IC50 for hemoglobin of 15 uM, which is in the range of plasma levels resulting from therapeutic doses of the drug in humans. Acetaminophen acts by reducing the ferryl-oxo radical form of the heme, and thereby prevents formation of the hemoprotein radical that initiates lipid peroxidation. To assess proof of concept in vivo, we determined the effect of acetaminophen in a rat model of rhabdomyolysis in which renal failure results from intense vasospasm. Acetaminophen blocked lipid peroxidation in this model, and prevented the renal failure with a dose that produced plasma levels in the therapeutic range for humans.
We also have demonstrated that N-acetylcysteine (NAC) will inhibit hemoprotein-catalyzed lipid peroxidation. Moreover, NAC administration increases the levels of glutathione in vivo, and glutathione is a co-substrate for the glutathione peroxidases that can reduce the levels of peroxides in the environment of the aSAH . This is important as acetaminophen is most potent in inhibiting hemoprotein-catalyzed lipid peroxidation when peroxide concentrations are low. This concerted evidence is the basis for a hypothesis that NAC will augment the efficacy of acetaminophen as an inhibitor of hemoprotein-catalyzed lipid peroxidation in aSAH.
These finding provide the rationale for a pilot study seeking proof of the concept that acetaminophen-based regimens can inhibit lipid peroxidation in patients with subarachnoid hemorrhage. Lipid peroxidation will be determined by analysis of F2-isoprostanes in cerebrospinal fluid. If such inhibition is seen, that then would provide a basis for a larger multi-center investigation to assess the effect on clinical endpoints.
This pilot study will determine whether APAP, NAC, and APAP in combination with NAC will inhibit lipid peroxidation in aneurysmal subarachnoid hemorrhage.
- Being tested
- Placebos for acetaminophen and N-acetylcysteine, APAP 1 gm every 6 hours and N-acetylcysteine placebo, NAC IV infusion at 0.5 gm hourly and APAP placebo, APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly, APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly
- Keywords
- Lipid, Peroxidation, N-Acetylcysteine, Acetaminophen, Vasospasm
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebos for acetaminophen and N-acetylcysteineDrug
Placebos for acetaminophen and N-acetylcysteine
APAP 1 gm every 6 hours and N-acetylcysteine placeboDrug
Acetaminophen 1 gm every 6 hours and N-acetylcysteine placebo
NAC IV infusion at 0.5 gm hourly and APAP placeboDrug
N-acetylcysteine IV infusion at 0.5 gm hourly and acetaminophen placebo
APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourlyDrug
Acetaminophen 1 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourlyDrug
Acetaminophen 1.5 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
| Study group | Role | What they receive |
|---|---|---|
| Placebos for acetaminophen and N-acetylcysteine | Placebo comparator | Placebos for acetaminophen and N-acetylcysteine Receives: Drug: Placebos for acetaminophen and N-acetylcysteine |
| Acetaminophen and N-acetylcysteine placebo | Active comparator | Acetaminophen 1 gm every 6 hours and N-acetylcysteine placebo Receives: Drug: APAP 1 gm every 6 hours and N-acetylcysteine placebo |
| N-acetylcysteine and acetaminophen | Active comparator | N-acetylcysteine IV infusion at 0.5 gm hourly and acetaminophen placebo Receives: Drug: NAC IV infusion at 0.5 gm hourly and APAP placebo |
| Acetaminophen 1 Gram and N-acetylcysteine | Active comparator | Acetaminophen 1 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly Receives: Drug: APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly |
| Acetaminophen 1.5 Gram and N-acetylcysteine | Active comparator | Acetaminophen 1.5 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly Receives: Drug: APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Vasospasm Based on Magnetic Resonance Angiography (MRA)
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.
Measured: 8 Days post subarachnoid hemorrhage (SAH) event
Number of Patients With Vasospasm Based on Computed Tomographic Angiography (CTA)
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.
Measured: 8 Days post subarachnoid hemorrhage (SAH) event
National Institutes of Health Stroke Scale (NIHSS) Score
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.
Measured: 8 Days post subarachnoid hemorrhage (SAH) event
Modified Rankin Scale (MRS) Score
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.
Measured: 8 Days post subarachnoid hemorrhage (SAH) event
Glasgow Outcome Scale (GOS) Score
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).
Measured: 8 Days post subarachnoid hemorrhage (SAH) event
The Barthel Index Score
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.
Measured: 8 Days post subarachnoid hemorrhage (SAH) event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startApr 2007
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Matthew Fusco, Vanderbilt University Medical Center
- Investigators
- Matthew Fusco, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585559
- Sponsor's protocol ID
- NIH P50 GM015431
- Other IDs
- VUMCIRB060556, P50GM015431
- Status last verified
- Mar 2025
- First submitted
- 26 Dec 2007
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of Lipid Peroxidation and Cerebral Vasospasm by an Acetaminophen-Based Regimen in Patients With Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT00585559
- Acronym / sponsor ID
- NIH P50 GM015431
- Keywords
- Lipid, Peroxidation, N-Acetylcysteine, Acetaminophen, Vasospasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- Apr 2007
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aneurysmal subarachnoid hemorrhage (aSAH) is an often devastating form of stroke with high morbidity and mortality despite advances in surgical management. Approximately 30,000 patients annually suffer aSAH in the U.S. For patients who survive the initial subarachnoid hemorrhage, delayed cerebral vasospasm occurring from days 4-14 is the greatest cause of neurological disability and death. A growing body of evidence incriminates hemoprotein-catalyzed lipid peroxidation as the mediator of the vasospasm.
Hemoglobin released from lysed red cells in the subarachnoid space becomes oxidized, in which state it acts as a pseudoperoxidase and generates the protein radicals that induce lipid peroxidation. F2-isoprostanes formed by this lipid peroxidation are highly potent constrictors of cerebral arterioles. We have demonstrated a more than 5 fold mean increase in F2-isoprostanes in the cerebrospinal fluid of patients with aSAH; this increase is maximal at the time of delayed vasospasm, and the level of increase is a function of the severity of the aSAH. We hypothesize that such vasoconstrictors are major contributors to the vasospasm produced by the hemoproteins, hemoglobin and myoglobin, in diseases in which they are released from their cellular confines.
We have discovered that acetaminophen (APAP) is a potent inhibitor of hemoprotein-catalyzed lipid peroxidation with an IC50 for hemoglobin of 15 uM, which is in the range of plasma levels resulting from therapeutic doses of the drug in humans. Acetaminophen acts by reducing the ferryl-oxo radical form of the heme, and thereby prevents formation of the hemoprotein radical that initiates lipid peroxidation. To assess proof of concept in vivo, we determined the effect of acetaminophen in a rat model of rhabdomyolysis in which renal failure results from intense vasospasm. Acetaminophen blocked lipid peroxidation in this model, and prevented the renal failure with a dose that produced plasma levels in the therapeutic range for humans.
We also have demonstrated that N-acetylcysteine (NAC) will inhibit hemoprotein-catalyzed lipid peroxidation. Moreover, NAC administration increases the levels of glutathione in vivo, and glutathione is a co-substrate for the glutathione peroxidases that can reduce the levels of peroxides in the environment of the aSAH . This is important as acetaminophen is most potent in inhibiting hemoprotein-catalyzed lipid peroxidation when peroxide concentrations are low. This concerted evidence is the basis for a hypothesis that NAC will augment the efficacy of acetaminophen as an inhibitor of hemoprotein-catalyzed lipid peroxidation in aSAH.
These finding provide the rationale for a pilot study seeking proof of the concept that acetaminophen-based regimens can inhibit lipid peroxidation in patients with subarachnoid hemorrhage. Lipid peroxidation will be determined by analysis of F2-isoprostanes in cerebrospinal fluid. If such inhibition is seen, that then would provide a basis for a larger multi-center investigation to assess the effect on clinical endpoints.
This pilot study will determine whether APAP, NAC, and APAP in combination with NAC will inhibit lipid peroxidation in aneurysmal subarachnoid hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebos for acetaminophen and N-acetylcysteine | Placebo comparator | Drug: Placebos for acetaminophen and N-acetylcysteinePlacebos for acetaminophen and N-acetylcysteine |
| Acetaminophen and N-acetylcysteine placebo | Active comparator | Drug: APAP 1 gm every 6 hours and N-acetylcysteine placeboAcetaminophen 1 gm every 6 hours and N-acetylcysteine placebo |
| N-acetylcysteine and acetaminophen | Active comparator | Drug: NAC IV infusion at 0.5 gm hourly and APAP placeboN-acetylcysteine IV infusion at 0.5 gm hourly and acetaminophen placebo |
| Acetaminophen 1 Gram and N-acetylcysteine | Active comparator | Drug: APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourlyAcetaminophen 1 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly |
| Acetaminophen 1.5 Gram and N-acetylcysteine | Active comparator | Drug: APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourlyAcetaminophen 1.5 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages ≥ 20
- Fisher Grade III or III + IV SAH based upon admitting CT scan
- Aneurysm secured by either clipping or coiling within 72 hours of SAH
- Intracranial aneurysm confirmed by angiography or CTA
- Presence of ventriculostomy for external ventricular drainage (EVD) prior to randomization
Key exclusion criteria (19 listed)
- Consent unobtainable
- Enrollment in another interventional study
- Patient is pregnant or lactating
- Known co-morbidities that could affect outcome of this study
- Contraindication to CTA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebos for acetaminophen and N-acetylcysteinePlacebos for acetaminophen and N-acetylcysteine | Drug | Placebos for acetaminophen and N-acetylcysteine |
| APAP 1 gm every 6 hours and N-acetylcysteine placeboAcetaminophen 1 gm every 6 hours and N-acetylcysteine placebo | Drug | Acetaminophen and N-acetylcysteine placebo |
| NAC IV infusion at 0.5 gm hourly and APAP placeboN-acetylcysteine IV infusion at 0.5 gm hourly and acetaminophen placebo | Drug | N-acetylcysteine and acetaminophen |
| APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourlyAcetaminophen 1 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly | Drug | Acetaminophen 1 Gram and N-acetylcysteine |
| APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourlyAcetaminophen 1.5 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly | Drug | Acetaminophen 1.5 Gram and N-acetylcysteine |
Primary outcome
Number of Patients With Vasospasm Based on Magnetic Resonance Angiography (MRA)
Time frame: 8 Days post subarachnoid hemorrhage (SAH) event
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.
Number of Patients With Vasospasm Based on Computed Tomographic Angiography (CTA)
Time frame: 8 Days post subarachnoid hemorrhage (SAH) event
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.
National Institutes of Health Stroke Scale (NIHSS) Score
Time frame: 8 Days post subarachnoid hemorrhage (SAH) event
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.
Modified Rankin Scale (MRS) Score
Time frame: 8 Days post subarachnoid hemorrhage (SAH) event
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.
Glasgow Outcome Scale (GOS) Score
Time frame: 8 Days post subarachnoid hemorrhage (SAH) event
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).
The Barthel Index Score
Time frame: 8 Days post subarachnoid hemorrhage (SAH) event
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Fusco, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly and APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly in people with Aneurysmal Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Vasospasm Based on Magnetic Resonance Angiography (MRA) (time frame: 8 Days post subarachnoid hemorrhage (SAH) event). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.