A Phase 3 interventional study of NBO and Control in Stroke Acute, sponsored by Capital Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Capital Medical University · Phase 3, Interventional, and Treatment
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Among 33 studies in Stroke by Capital Medical University — 7 open to participants now, 10 under way, 3 of them phase 3. Stroke · Capital Medical University.
Among the 33 studies in Stroke by Capital Medical University, this one is the 2nd largest by planned enrollment of the 28 interventional ones that give a count, is one of 4 that started in 2025, is one of 3 in phase 3, and was the 26th registered.
8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.
Browse Stroke studies →7 of the 33 studies in Stroke by Capital Medical University are open now, in 1 country. Recruiting first, the newest first:
Capital Medical University · Sites in China
Ages 18–80
Capital Medical University · Sites in China
Ages 18+
Capital Medical University · Sites in China
Ages 18+
Capital Medical University · Sites in China
Ages 18–80
Capital Medical University · Sites in China
Ages 18+
By country, each count listing its studies:
Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 10 · Phase 3 7
First in 2010; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,000 is above the median of 49 across 6,027 interventional studies indexed under Stroke.
Median enrollment 168 across the 28 interventional studies, 500 across the 5 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Capital Medical University is the lead sponsor of 296 studies on the registry; 90 are open to participants now.
5 of the studies in Stroke by Capital Medical University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07513233Capital Medical UniversityAnisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL) | 2026-11-20 |
| NCT07139314Capital Medical UniversityTiming of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation 2 | 2026-11-30 |
| NCT07800572Capital Medical UniversityAnisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL-2) | 2026-12-31 |
| NCT07785492Capital Medical UniversityArtificial Intelligence Support for Stroke | 2026-12-31 |
| NCT07139301Capital Medical UniversityTiming of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation | 2027-01-17 |
Add all 5 to your calendar (.ics) → With an account.
Among the 33 studies in Stroke by Capital Medical University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NBO will be conducted with inhalation of 100% oxygen. NBO will be used in conjunction with best medical practice.
Other: NBO
Best medical treatment
Other: Control
NBO will be conducted with inhalation of 100% oxygen.
Best medical care
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
Time frame: 90 days after randomization
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0
NCCT infarct volume at 24 hours in patients undergoing thrombolysis or EVT (standard of care)
Infarct volume measured by NCCT
Time frame: 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.
Time frame: Day 0
Serious adverse events/Adverse events
total number of serious adverse events/adverse events reported during follow-up, according to standard definitions
Time frame: Through study completion
Symptomatic intracranial hemorrhage
Number of cases of symptomatic intracerebral hemorrhage according to standard definition
Time frame: Up to 36 hours after randomization
Any intracranial hemorrhage
Number of cases of any intracranial hemorrhage according to standard definitions
Time frame: Up to 36 hours after randomization
Early neurological deterioration
Early neurological deterioration at 24 hours, defined as at least 4-point increase in National Institutes of Health Stroke Scale (NIHSS) score from baseline; Larger the increase means worsening of outcomes. The Increase of score range from 0 to 42.
Time frame: 24 hours after randomization
Heart rate at the end of oxygen therapy
Vital signs at the end of oxygen therapy
Time frame: Day 0
Respiratory rate at the end of oxygen therapy
Vital signs at the end of oxygen therapy
Time frame: Day 0
Systolic blood pressure at the end of oxygen therapy
Vital signs at the end of oxygen therapy
Time frame: Day 0
Diastolic blood pressure at the end of oxygen therapy
Vital signs at the end of oxygen therapy
Time frame: Day 0
Oxygen saturation at the end of oxygen therapy
Vital signs at the end of oxygen therapy
Time frame: Day 0
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Jan 2028, 35 months later.
Of 92 non-industry phase 3 interventional studies under Stroke, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's planned 35 months is below that.
Counting every sponsor, half of 129 studies reached it within 44 months; a quarter within 27 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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