Stroke AcutePhase 3AN-O2-EMSNCT06801457
Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke
A Phase 3 study testing NBO in people with Stroke Acute, run by Capital Medical University at 1 site in China.
Trial summary
The primary objective of this study is to determine the efficacy and safety of inhaled normobaric hyperoxia therapy (NBO) beginning in the pre-hospital setting in patients with suspected acute cerebral ischemia (ACI) due to large vessel occlusion presenting within 6 hours of symptom onset. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute
- What is being tested?
- NBO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 30 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years old;
- Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);
- No prior stroke;
- The time from stroke onset/last seen well to randomization is within 6 hours;
- Paramedic-obtained FAST-ED score >= 3 (The enrollment of patients with a FAST-ED score of 3 is prespecified to constitute no more than 10% of the total study population);
- No significant pre-stroke disability (pre-stroke mRS 0-1);
- Signed informed consent from the patient or the legally authorized representative (LAR).
Who cannot join
- Endotracheal intubation in the field (prior to consent);
- Respiratory rate <= 10 or >= 30 breaths per minute;
- Oxygen-dependence at baseline to maintain SaO2 > 95%;
- Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
- Seizure at stroke onset;
- Exhibiting symptoms of vomiting, severe headache, or unconscious;
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- Known pregnancy: women of childbearing age (18 to 44 years old according to the CDC's Division of Reproductive Health) will be asked about their pregnancy status.
- Participating in another clinical trial, or completed participation within prior 30 days;
- Receiving other neuroprotective agent (e.g., edaravone dexborneol, n-butylphthalide);
- Life expectancy < 90 days due to comorbidities;
- Unlikely to complete the 90-day follow-up visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Wenbo Hu, MD, 010-83911991, huwenbo0050@163.com
About this study
The primary objective of this study is to determine the efficacy and safety of inhaled normobaric hyperoxia therapy (NBO) beginning in the pre-hospital setting in patients with suspected acute cerebral ischemia (ACI) due to large vessel occlusion presenting within 6 hours of symptom onset.
Read the detailed description
Stroke is a leading cause of death and disability globally, with acute ischemic stroke (AIS) patients often benefiting from intravenous thrombolysis and endovascular therapies such as mechanical thrombectomy, which have been shown to improve reperfusion rates. However, despite reperfusion, the proportion of patients with large vessel occlusion achieving a favorable functional outcome, defined as a modified Rankin Scale score of 0-2 at 90 days, remains under 50%.
Normobaric hyperoxia (NBO) emerges as a compelling option for cerebral protection. Its neuroprotective mechanisms are thought to include hypoxic tissue rescue, blood-brain barrier preservation, brain edema reduction, neuroinflammation alleviation, mitochondrial function improvement, oxidative stress mitigation, and apoptosis inhibition. NBO's diffusion properties allow it to reach the penumbra before reperfusion, enhancing aerobic metabolism and potentially reducing infarct volume. Its advantages also include low cost, wide availability, and ease of use, making it accessible across various healthcare settings.
- Conditions
- Stroke Acute
- Being tested
- NBO, Control
- Keywords
- Ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBOOther
NBO will be conducted with inhalation of 100% oxygen.
ControlOther
Best medical care
| Study group | Role | What they receive |
|---|---|---|
| NBO | Experimental | NBO will be conducted with inhalation of 100% oxygen. NBO will be used in conjunction with best medical practice. Receives: Other: NBO |
| Control | Other | Best medical treatment Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of disability at 90 days measured by modified Rankin scale (mRS) score
The original modified Rankin scale (mRS) ranges from 0 to 6, with higher scores indicating a worse outcome; the primary outcome here is 3-month ordinal mRS score with mRS 5 and 6 merged into one category; modified intention-to-treat analysis
Measured: 90 days after randomization
Secondary outcomes (7)
Functional independence at 90 days defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up
The original modified Rankin scale (mRS) ranges from 0 to 6, with higher scores indicating a worse outcome. The mRS score is dichotomized to define the functional independence as mRS score of 0-2.
Measured: 90 days after randomization
Excellent functional outcome at 90 days, defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up
The original modified Rankin scale (mRS) ranges from 0 to 6, with higher scores indicating a worse outcome. The mRS score is dichotomized to define the excellent functional outcome as mRS score of 0-1.
Measured: 90 days after randomization
National Institutes of Health Stroke Scale (NIHSS) obtained obtained upon Endovascular Thrombectomy (EVT) site arrival
The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42 points, with higher scores indicating worse neurological deficits. This is obtained upon Endovascular Thrombectomy (EVT) site arrival.
Measured: Day 0
National Institutes of Health Stroke Scale (NIHSS) obtained at 24 hours
The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42 points, with higher scores indicating worse neurological deficits.
Measured: 24 hours after randomization
ASPECTS on admission head CT
Alberta Stroke Program Early CT (ASPECT) score ranges from 0 to 10, with 10 being normal and 0 indicating complete MCA infarction obtained upon Endovascular Thrombectomy (EVT) site arrival.
Measured: Day 0
NCCT infarct volume at 24 hours in patients undergoing thrombolysis or EVT (standard of care)
Infarct volume measured by NCCT
Measured: 24 hours after randomization
Proportion of patients with elevated troponin level upon EVT hospital arrival
0-100%. This measure is obtained upon Endovascular Thrombectomy (EVT) site arrival.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke AcuteStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801457
- Sponsor's protocol ID
- AN-O2-EMS
- Acronym
- AN-O2-EMS
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke
- ClinicalTrials.gov ID
- NCT06801457
- Acronym / sponsor ID
- AN-O2-EMS / AN-O2-EMS
- Conditions
- Stroke Acute
- Keywords
- Ischemic stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the efficacy and safety of inhaled normobaric hyperoxia therapy (NBO) beginning in the pre-hospital setting in patients with suspected acute cerebral ischemia (ACI) due to large vessel occlusion presenting within 6 hours of symptom onset.
Detailed description
Stroke is a leading cause of death and disability globally, with acute ischemic stroke (AIS) patients often benefiting from intravenous thrombolysis and endovascular therapies such as mechanical thrombectomy, which have been shown to improve reperfusion rates. However, despite reperfusion, the proportion of patients with large vessel occlusion achieving a favorable functional outcome, defined as a modified Rankin Scale score of 0-2 at 90 days, remains under 50%.
Normobaric hyperoxia (NBO) emerges as a compelling option for cerebral protection. Its neuroprotective mechanisms are thought to include hypoxic tissue rescue, blood-brain barrier preservation, brain edema reduction, neuroinflammation alleviation, mitochondrial function improvement, oxidative stress mitigation, and apoptosis inhibition. NBO's diffusion properties allow it to reach the penumbra before reperfusion, enhancing aerobic metabolism and potentially reducing infarct volume. Its advantages also include low cost, wide availability, and ease of use, making it accessible across various healthcare settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBO | Experimental | Other: NBONBO will be conducted with inhalation of 100% oxygen. NBO will be used in conjunction with best medical practice. |
| Control | Other | Other: ControlBest medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 80 years old;
- Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);
- No prior stroke;
- The time from stroke onset/last seen well to randomization is within 6 hours;
- Paramedic-obtained FAST-ED score >= 3 (The enrollment of patients with a FAST-ED score of 3 is prespecified to constitute no more than 10% of the total study population);
Key exclusion criteria (11 listed)
- Endotracheal intubation in the field (prior to consent);
- Respiratory rate <= 10 or >= 30 breaths per minute;
- Oxygen-dependence at baseline to maintain SaO2 > 95%;
- Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
- Seizure at stroke onset;
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 |
|---|---|---|
| NBONBO will be conducted with inhalation of 100% oxygen. | Other | NBO |
| ControlBest medical care | Other | Control |
Primary outcome
Level of disability at 90 days measured by modified Rankin scale (mRS) score
Time frame: 90 days after randomization
The original modified Rankin scale (mRS) ranges from 0 to 6, with higher scores indicating a worse outcome; the primary outcome here is 3-month ordinal mRS score with mRS 5 and 6 merged into one category; modified intention-to-treat analysis
7 secondary outcomes
Functional independence at 90 days defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up
Time frame: 90 days after randomization
Excellent functional outcome at 90 days, defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up
Time frame: 90 days after randomization
National Institutes of Health Stroke Scale (NIHSS) obtained obtained upon Endovascular Thrombectomy (EVT) site arrival
Time frame: Day 0
National Institutes of Health Stroke Scale (NIHSS) obtained at 24 hours
Time frame: 24 hours after randomization
ASPECTS on admission head CT
Time frame: Day 0
NCCT infarct volume at 24 hours in patients undergoing thrombolysis or EVT (standard of care)
Time frame: 24 hours after randomization
Proportion of patients with elevated troponin level upon EVT hospital arrival
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 NBO in people with Stroke Acute, run by Capital Medical University at 1 site in China.
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 30 Jan 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lan Liu, PhD (8683911991, liulan1815@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of disability at 90 days measured by modified Rankin scale (mRS) score (time frame: 90 days after randomization). 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 30 Jan 2025.