Acute Ischemic StrokePhase 3NCT05965687
Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3)
A Phase 3 study testing Normobaric Hyperoxia, Nasal oxygen and Intravenous thrombolysis(rt-PA) in people with Acute Ischemic Stroke, run by Ji Xunming,MD,PhD at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Normobaric Hyperoxia, Nasal oxygen and Intravenous thrombolysis(rt-PA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,230 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2023to 16 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years;
- The time from onset to randomization is within 4.5 hours of onset;
- The clinical diagnosis is acute ischemic stroke (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
- Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;
- Pre-stroke mRS score≤1 points;
- Informed consent from the patient or surrogate.
Who cannot join
- Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
- Past history of intracranial hemorrhage;
- Rapid neurological function improvement, NIHSS score less than 5 points;
- Presence of proximal arterial occlusion on computed tomographic angiography(CTA)/magnetic resonance angiography(MRA) (e.g., intracranial internal carotid artery(ICA), middle cerebral artery(MCA)-M1, and vertebrobasilar arteries);
- Massive anterior cerebral infarction identified by CT or MRI (ASPECT < 6 or lesions larger than one third of the territory of the middle cerebral artery);
- Intended to proceed endovascular treatment;
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- Pregnant women, or planning to become pregnant during the trial;
- A history of severe head trauma or stroke within 3 months;
- A history of intracranial or spinal surgery within 3 months;
- A history of gastrointestinal or urinary bleeding within 3 weeks;
- two weeks of major surgery;
- Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
- Active visceral bleeding;
- Intracranial tumors, large intracranial aneurysms;
- Aortic arch dissection was found;
- Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg);
- Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol);
- Oral warfarin anticoagulant with international normalized ratio(INR)>1.7 or prothrombin time(PT)>15 s;
- Heparin treatment was received within 24 h;
- Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
- Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
- Hereditary or acquired bleeding constitution;
- Onset with seizures;
- Severe liver and kidney dysfunction;
- Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
- Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
- Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen;
- Life expectancy < 1 year;
- Patients who could not complete the 90-day follow-up;
- Participation in other clinical trials within 3 months prior to screening;
- Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.
Read the detailed description
In this study, cases of acute ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The Normobaric Hyperoxia(NBO) group receive basic intravenous thrombolysis and given 100% oxygen inhalation at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. The control group receive basic intravenous thrombolysis and given oxygen inhalation at a ventilation rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. The investigators aimed to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Normobaric Hyperoxia, Nasal oxygen, Intravenous thrombolysis(rt-PA)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normobaric HyperoxiaProcedure or surgery
Within 4.5 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.
Nasal oxygenProcedure or surgery
For nasal oxygen group, patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%.
Intravenous thrombolysis(rt-PA)Drug
10% dose of rt-PA (0.9 mg/kg) is given as bolus and the rest given as an infusion over the remaining 1 hour. Maximum dose 90mg.
| Study group | Role | What they receive |
|---|---|---|
| NBO group | Experimental | Normobaric Hyperoxia combined with intravenous thrombolysis Receives: Procedure: Normobaric Hyperoxia; Drug: Intravenous thrombolysis(rt-PA) |
| Control group | Placebo comparator | Nasal oxygen combined with intravenous thrombolysis Receives: Procedure: Nasal oxygen; Drug: Intravenous thrombolysis(rt-PA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility-weighted modified Rankin scale scores
Utility-weighted modified Rankin scale scores
Measured: 90±7 days after randomization
Secondary outcomes (30)
Cerebral infarct volume
The infarct volume of cerebral infarct is evaluated by MRI
Measured: 24-48hours after randomization
modified rankin scale (mRS) score
Ordinal distribution of mRS at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome
Measured: 90±7 days after randomization
Good functional outcome
Proportion of subjects with modified rankin scale (mRS) 0-2 at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome
Measured: 90 ± 7 days after randomization
Proportion of subjects with modified rankin scale (mRS) 0-3
Proportion of subjects with mRS 0-3 at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome
Measured: 90 ± 7 days after randomization
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits
Measured: 4 ± 2 hours, 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization
The proportion of neurological function improvement
≥ 4 point reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 ± 6 hours after randomization;NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome
Measured: 24 ± 6 hours after randomization
Proportion of subjects with modified rankin scale (mRS) 0-1
Proportion of subjects with mRS 0-1 at 30±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome
Measured: 30 ± 7 days after randomization
Barthel Index (BI)
The BI is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)
Measured: 30 ± 7 days,90 ± 7 days after randomization
EuroQol five dimensions questionnaire（EQ-5D）
The score ranges from 0 to 100, with higher scores indicating optimal health
Measured: baseline before randomization,7 ± 2 days,30 ± 7 days,90 ± 7 days after randomization
Days of hospitalization
Length of stay in hospital
Measured: 30 ± 7 days after randomization
Stroke-related mortality
Safety endpoint; the proportion of stroke related deaths in each group
Measured: 90 ± 7 days after randomization
All-cause mortality
Safety endpoint; the proportion of all patients who died in each group
Measured: 90 ± 7 days after randomization
Symptomatic intracranial hemorrhage
Proportion of subjects with symptomatic intracranial hemorrhage at 24 ± 6 hours after randomization (defined by ECASSII and ECASS III)
Measured: 24 ± 6 hours after randomization
Asymptomatic intracranial hemorrhage
The incidence of asymptomatic intracranial hemorrhage at 24 ± 6 hours after randomization
Measured: 24 ± 6 hours after randomization
PH2 intracranial hemorrhage
The incidence of PH2 intracranial hemorrhage at 24 ± 6 hours after randomization (according to SITS standards)
Measured: 24 ± 6 hours after randomization
Any intracranial hemorrhage
The incidence of any intracranial hemorrhage at 24 ± 6 hours after randomization
Measured: 24 ± 6 hours after randomization
Systematic bleeding
The incidence of systematic bleeding at 24 ± 6 hours after randomization
Measured: 24 ± 6 hours after randomization
Early neurological deterioration
Safety endpoint; defined as ≥4 point increase in National Institutes of Health Stroke Scale (NIHSS) score from baseline;NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome
Measured: 24 ± 6 hours after randomization
Oxygen-related adverse events
Safety endpoint; the proportion of oxygen-related adverse events in each group, including severe lung infection, pneumothorax, atelectasis, respiratory failure, acute respiratory distress syndrome, and cardiopulmonary arrest
Measured: 90 ± 7 days after randomization
Adverse events/serious adverse events
Safety endpoint; the proportion of adverse events/serious adverse events in each group
Measured: 24 ± 12 hours, 7 ± 2 days, 90± 7 days after randomization
PaO2 of arterial blood gas analysis
Safety endpoint
Measured: after 4 hours of oxygen therapy
PaCO2 of arterial blood gas analysis
Safety endpoint
Measured: after 4 hours of oxygen therapy
Potential of hydrogen(PH) of arterial blood gas analysis
Safety endpoint
Measured: after 4 hours of oxygen therapy
Concentration of Lactic acid of arterial blood gas analysis
Safety endpoint
Measured: after 4 hours of oxygen therapy
Systolic and diastolic blood pressure
Safety endpoint; vital signs
Measured: 24 ± 6 hours after randomization
Heart rate
Safety endpoint; vital signs
Measured: 24 ± 6 hours after randomization
Respiratory rate
Safety endpoint; vital signs
Measured: 24 ± 6 hours after randomization
Oxygen saturation
Safety endpoint; vital signs
Measured: 24 ± 6 hours after randomization
Unit costs
Unit costs will be attached to resource use, patient-reported and from hospital records after randomization, to obtain a cost per patient over the period of follow-up
Measured: 7 ± 2 days, 30 ± 7 days,90 ± 7 days after randomization
Excellent functional outcome
Proportion of subjects with modified Rankin Scale(mRS) 0-1 at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome
Measured: 90±7 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start17 Aug 2023
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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
- 1,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ji Xunming,MD,PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing Tongren Hospital, People's Hospital of Beijing Daxing District, Tianjin Huanhu Hospital, Guizhou Provincial People's Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Xuzhou Medical University, Jining First People's Hospital, Linyi People's Hospital, Nanyang Central Hospital, Rizhao People's Hospital, Zhumadian Central Hospital, Second Affiliated Hospital of Nanchang University, Affiliated Hospital of Nantong University, The Second Hospital of Anhui Medical University, Changsha Central Hospital, Jiujiang University Affiliated Hospital, Liaocheng People's Hospital, Chengde Central Hospital, The First Affiliated Hospital of Anhui Medical University, Jiangxi Provincial People's Hopital
- Responsible party
- Sponsor-investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965687
- Sponsor's protocol ID
- OPENS-3
- Status last verified
- Jul 2026
- First submitted
- 7 Jun 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3)
- ClinicalTrials.gov ID
- NCT05965687
- Acronym / sponsor ID
- OPENS-3
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- Ji Xunming,MD,PhDUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing Tongren Hospital, People's Hospital of Beijing Daxing District, Tianjin Huanhu Hospital, Guizhou Provincial People's Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Xuzhou Medical University, Jining First People's Hospital, Linyi People's Hospital, Nanyang Central Hospital, Rizhao People's Hospital, Zhumadian Central Hospital, Second Affiliated Hospital of Nanchang University, Affiliated Hospital of Nantong University, The Second Hospital of Anhui Medical University, Changsha Central Hospital, Jiujiang University Affiliated Hospital, Liaocheng People's Hospital, Chengde Central Hospital, The First Affiliated Hospital of Anhui Medical University, Jiangxi Provincial People's Hopital
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 28 Jul 2023 (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 purpose of this study is to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.
Detailed description
In this study, cases of acute ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The Normobaric Hyperoxia(NBO) group receive basic intravenous thrombolysis and given 100% oxygen inhalation at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. The control group receive basic intravenous thrombolysis and given oxygen inhalation at a ventilation rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. The investigators aimed to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBO group | Experimental | Procedure: Normobaric Hyperoxia, Drug: Intravenous thrombolysis(rt-PA)Normobaric Hyperoxia combined with intravenous thrombolysis |
| Control group | Placebo comparator | Procedure: Nasal oxygen, Drug: Intravenous thrombolysis(rt-PA)Nasal oxygen combined with intravenous thrombolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥18 years;
- The time from onset to randomization is within 4.5 hours of onset;
- The clinical diagnosis is acute ischemic stroke (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
- Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;
- Pre-stroke mRS score≤1 points;
Key exclusion criteria (31 listed)
- Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
- Past history of intracranial hemorrhage;
- Rapid neurological function improvement, NIHSS score less than 5 points;
- Presence of proximal arterial occlusion on computed tomographic angiography(CTA)/magnetic resonance angiography(MRA) (e.g., intracranial internal carotid artery(ICA), middle cerebral artery(MCA)-M1, and vertebrobasilar arteries);
- Massive anterior cerebral infarction identified by CT or MRI (ASPECT < 6 or lesions larger than one third of the territory of the middle cerebral artery);
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 |
|---|---|---|
| Normobaric HyperoxiaWithin 4.5 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0. | Procedure or surgery | NBO group |
| Nasal oxygenFor nasal oxygen group, patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%. | Procedure or surgery | Control group |
| Intravenous thrombolysis(rt-PA)10% dose of rt-PA (0.9 mg/kg) is given as bolus and the rest given as an infusion over the remaining 1 hour. Maximum dose 90mg. | Drug | Control group, NBO group |
Primary outcome
Utility-weighted modified Rankin scale scores
Time frame: 90±7 days after randomization
Utility-weighted modified Rankin scale scores
30 secondary outcomes
Cerebral infarct volume
Time frame: 24-48hours after randomization
modified rankin scale (mRS) score
Time frame: 90±7 days after randomization
Good functional outcome
Time frame: 90 ± 7 days after randomization
Proportion of subjects with modified rankin scale (mRS) 0-3
Time frame: 90 ± 7 days after randomization
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
Time frame: 4 ± 2 hours, 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization
The proportion of neurological function improvement
Time frame: 24 ± 6 hours after randomization
Proportion of subjects with modified rankin scale (mRS) 0-1
Time frame: 30 ± 7 days after randomization
Barthel Index (BI)
Time frame: 30 ± 7 days,90 ± 7 days after randomization
EuroQol five dimensions questionnaire（EQ-5D）
Time frame: baseline before randomization,7 ± 2 days,30 ± 7 days,90 ± 7 days after randomization
Days of hospitalization
Time frame: 30 ± 7 days after randomization
Stroke-related mortality
Time frame: 90 ± 7 days after randomization
All-cause mortality
Time frame: 90 ± 7 days after randomization
Symptomatic intracranial hemorrhage
Time frame: 24 ± 6 hours after randomization
Asymptomatic intracranial hemorrhage
Time frame: 24 ± 6 hours after randomization
PH2 intracranial hemorrhage
Time frame: 24 ± 6 hours after randomization
Any intracranial hemorrhage
Time frame: 24 ± 6 hours after randomization
Systematic bleeding
Time frame: 24 ± 6 hours after randomization
Early neurological deterioration
Time frame: 24 ± 6 hours after randomization
Oxygen-related adverse events
Time frame: 90 ± 7 days after randomization
Adverse events/serious adverse events
Time frame: 24 ± 12 hours, 7 ± 2 days, 90± 7 days after randomization
PaO2 of arterial blood gas analysis
Time frame: after 4 hours of oxygen therapy
PaCO2 of arterial blood gas analysis
Time frame: after 4 hours of oxygen therapy
Potential of hydrogen(PH) of arterial blood gas analysis
Time frame: after 4 hours of oxygen therapy
Concentration of Lactic acid of arterial blood gas analysis
Time frame: after 4 hours of oxygen therapy
Systolic and diastolic blood pressure
Time frame: 24 ± 6 hours after randomization
Heart rate
Time frame: 24 ± 6 hours after randomization
Respiratory rate
Time frame: 24 ± 6 hours after randomization
Oxygen saturation
Time frame: 24 ± 6 hours after randomization
Unit costs
Time frame: 7 ± 2 days, 30 ± 7 days,90 ± 7 days after randomization
Excellent functional outcome
Time frame: 90±7 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Normobaric Hyperoxia, Nasal oxygen and Intravenous thrombolysis(rt-PA) in people with Acute Ischemic Stroke, run by Ji Xunming,MD,PhD 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 6 inclusion and 31 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: finished, as of the sponsor's last update on 30 Jul 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Utility-weighted modified Rankin scale scores (time frame: 90±7 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 Jul 2026.