Acute Ischemic StrokePhase 3NCT05965193
Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke：Longterm Outcome (OPENS-3L)
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 long-term 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, Medical device
- 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 30 Oct 2025
- 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 tomography angiography(CTA)/magnetic resonance angiography(MRA) (e.g., intracranial internal carotid artery(ICA), middle cerebral arterial(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 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.
China1 site, 1 recruiting
- Recruiting
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100069
Xunming Ji, MD. PhD, 861013120136877, jixunming@vip.163.com
Hetao Bian, MD. PhD, 18266806812, hetaobian@163.com
About this study
The purpose of this study is to determine the long-term 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 long-term effect 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 HyperoxiaDevice
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 oxygenDevice
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: Device: Normobaric Hyperoxia; Drug: Intravenous thrombolysis(rt-PA) |
| Control group | Placebo comparator | Nasal oxygen combined with intravenous thrombolysis Receives: Device: 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: 12 months±14 days after randomization
Secondary outcomes (16)
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 12 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
Measured: 12 months±14 days after randomization
Good functional outcome
Proportion of subjects with modified rankin scale (mRS) 0-2 at 12 months±14 days after randomization
Measured: 12 months±14 days after randomization
Excellent functional outcome
Proportion of subjects with modified Rankin Scale (mRS) 0-1 at 6 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
Measured: 6 months±14 days after randomization
Good functional outcome
Proportion of subjects with modified rankin scale (mRS) 0-2 at 6 months±14 days after randomization
Measured: 6 months±14 days after randomization
modified Rankin Scale (mRS) score
Ordinal distribution of mRS at 6 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
Measured: 6 months±14 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
Barthel Index (BI)
The BI is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)
Measured: 6 months±14 days,12 months±14 days after randomization
EuroQol five dimensions questionnaire（EQ-5D）
The score ranges from 0 to 100, with higher scores indicating optimal health
Measured: 6 months±14 days,12 months±14 days after randomization
Stroke-related mortality
Safety endpoint; the proportion of stroke related deaths in each group
Measured: 12 months±14 days after randomization
All-cause mortality
Safety endpoint; the proportion of all patients who died in each group
Measured: 12 months±14 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
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, 6 months±14 days,12 months±14 days after randomization
Excellent functional outcome
Proportion of subjects with modified Rankin Scale (mRS) 0-1 at 12 months±14 days after randomization; mRS score ranges from 0 to 5, and the higher score means a worse outcome
Measured: 12 months±14 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 completion30 Aug 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
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 (estimated)
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
- Responsible party
- Sponsor-investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965193
- Sponsor's protocol ID
- OPENS-3L
- Status last verified
- Mar 2024
- First submitted
- 14 Jun 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. 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：Longterm Outcome (OPENS-3L)
- ClinicalTrials.gov ID
- NCT05965193
- Acronym / sponsor ID
- OPENS-3L
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,230 participants (estimated)
- 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
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- 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 long-term 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 long-term effect 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 | Device: Normobaric Hyperoxia, Drug: Intravenous thrombolysis(rt-PA)Normobaric Hyperoxia combined with intravenous thrombolysis |
| Control group | Placebo comparator | Device: 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 tomography angiography(CTA)/magnetic resonance angiography(MRA) (e.g., intracranial internal carotid artery(ICA), middle cerebral arterial(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. | Device | 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%. | Device | 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: 12 months±14 days after randomization
Utility-weighted modified Rankin scale scores
16 secondary outcomes
Cerebral infarct volume
Time frame: 24-48hours after randomization
modified Rankin Scale (mRS) score
Time frame: 12 months±14 days after randomization
Good functional outcome
Time frame: 12 months±14 days after randomization
Excellent functional outcome
Time frame: 6 months±14 days after randomization
Good functional outcome
Time frame: 6 months±14 days after randomization
modified Rankin Scale (mRS) score
Time frame: 6 months±14 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
Barthel Index (BI)
Time frame: 6 months±14 days,12 months±14 days after randomization
EuroQol five dimensions questionnaire（EQ-5D）
Time frame: 6 months±14 days,12 months±14 days after randomization
Stroke-related mortality
Time frame: 12 months±14 days after randomization
All-cause mortality
Time frame: 12 months±14 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
Adverse events/serious adverse events
Time frame: 24 ± 12 hours, 7 ± 2 days, 90± 7 days, 6 months±14 days,12 months±14 days after randomization
Excellent functional outcome
Time frame: 12 months±14 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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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.
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: status not confirmed, as of the sponsor's last update on 28 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility-weighted modified Rankin scale scores (time frame: 12 months±14 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 28 Mar 2024.