Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3) (NCT05965687) | Clinical Trial Compass
CompletedPhase 3
Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3)
China1,230 participantsStarted 2023-08-17
Plain-language summary
The purpose of this study is to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. 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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested breathing high-concentration oxygen alongside the clot-dissolving drug tPA for acute ischemic stroke — is that combination something that might have been relevant to my situation, and what do the results so far suggest about whether it helped patients recover better function?
2The trial measured outcomes using something called the utility-weighted modified Rankin scale, which captures how much disability affects quality of life — based on those results, what level of functional recovery were patients in this trial actually achieving compared to standard stroke care alone?
3Since this is a Phase 3 trial that has already completed, does that mean there are findings available that you could walk me through, and how might those results influence the treatment approach you'd recommend for me?
4The treatment involved normobaric hyperoxia, meaning breathing extra oxygen at normal air pressure through a mask — are there any risks or side effects associated with that approach that patients in the trial experienced, and would those matter given my specific health profile?
5If the results from this completed trial show benefit from adding oxygen therapy to thrombolysis, is that something that could be offered to stroke patients now outside of a trial setting, or is it still considered experimental?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;
. Pregnant women, or planning to become pregnant during the trial;
. A history of severe head trauma or stroke within 3 months;