Ischemic StrokePhase 3AN-O2NCT06666764
Normobaric Oxygen in AIS Transferred for EVT
A Phase 3 study testing NBO in people with Ischemic Stroke, run by Capital Medical University at 112 sites in China.
Trial summary
The primary objective of this study is to estimate the efficacy and safety of NBO on 3-month functional outcome after acute ischemic stroke Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- NBO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 112 sitesChina
- Study dates
- 13 Dec 2024to Oct 2027
- 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 at least 18 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 in the last 3 months;
- Time from stroke onset (last seen well) to randomization is within 9 hours;
- (1) Baseline NIHSS score at 6 or more and Intracranial ICA or MCA-M1 or MCA-M2 dominant occlusion, with or without tandem cervical carotid stenosis or tandem cervical occlusion, confirmed by preoperative CTA (or MRA, DSA) and consistent with signs and symptoms; or (2) Baseline NIHSS score at 6 or more with a hyperdense MCA sign on non-contrast CT; or (3) Baseline NIHSS score at 12 or more;
- NIHSS score 0 or 1 in the section of level of consciousness;
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- No significant pre-stroke disability (pre-stroke mRS 0--1);
- ASPECTS at least 6 on non-contrast CT;
- Patient is planned for transfer to a EVT-capable hospital for EVT;
- Signed informed consent from the patient or the legally authorized representative (LAR).
Who cannot join
- Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III or IV, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
- Respiratory rate <= 10 or >= 30 breaths per minute;
- Oxygen-dependence at baseline to maintain SaO2 > 95% or intubation at baseline;
- Seizure at stroke onset;
- Exhibiting symptoms of vomiting, or severe headache, or unconscious;
- Rapidly improving neurological deficits or transient ischemic attack prior to consent;
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- Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal;
- Evidence of intracranial tumor (except small meningioma) or arteriovenous malformation;
- Woman of childbearing potential known to be pregnant or with a positive pregnancy test;
- Life expectancy < 90 days due to comorbidity;
- Unlikely to complete the 90-day follow-up;
- Participating in another clinical treatment trial, or completed participation within prior 30 days;
- Receiving other cerebral protective agent (e.g., edaravone dexborneol, n-butylphthalide);
- Evidence of acute intracranial hemorrhage on CT/MRI;
- Significant mass effect with midline shift, defined as any deviation of midline structures such as the septum pellucidum, is observed on CT/MRI scans.
Trial locations and contacts
112 sites in 1 country. Contact the study team or a site near you to ask about taking part.
112 sites in 1 country
China112 sites, 112 recruiting
- Recruiting
Baoji High-Tech Hospital
Baoji, Shaanxi
Wenjuan Li, (0917)3120120, bjgxrmyy@163.com
- Recruiting
Caijiapo Hospital
Baoji, Shaanxi
Yanan Yang, 0917-8558127, 704210949@qq.com
- Recruiting
Longxian People's Hospital
Baoji, Shaanxi
Zhen Zhang, 0917-4604695, bjgxrmyy@163.com
- Not yet recruiting
Meixian Traditional Chinese Medicine Hospital
Baoji, Shaanxi
Huaijun Yuan, 0917-5542271, csky1@kykf888.com
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Wenbo Hu, MD, 010-83911991, huwenbo0050@163.com
Jian Miao, MD, 010-83911991, yadxmiaojian@sina.com
- Recruiting
Cangzhou Central Hospital
Cangzhou, Hebei
Jing Wang, (0317)2075013, czzxyygcp@126.com
- Recruiting
Dongguang County People's Hospital
Cangzhou, Hebei
Hongliang Guo, 0317-7720818, yahong27@126.com
- Recruiting
Xianxian Traditional Chinese Medicine Hospital
Cangzhou, Hebei
Mei'e Li, 0317-4506199, hxzb0317@163.com
- Recruiting
Binchuan County People's Hospital
Dali, Yunnan
Ronglu Yang, 0872-7140169, bcxrmyy@126.com
- Recruiting
Binchuan County Traditional Chinese Medicine Hospital
Dali, Yunnan
Si Yang, 0872-7145253, 775414845@qq.com
- Recruiting
Dali Prefecture People's Hospital
Dali, Yunnan
Shiyu Zou, (0872)2125465, dlzyykyglk@126.com
- Recruiting
Heqing County People's Hospital
Dali, Yunnan
Linglin Huang, 0872-4121666, ynhqxrmyy@126.com
- Recruiting
Jianchuan County People's Hospital
Dali, Yunnan
Junhua Zhang, 0872-4521244, jcxrmyy@126.com
- Recruiting
Midu County People's Hospital
Dali, Yunnan
Zhimin Zhao, 0872-8165872, mdxrmyy@126.com
- Recruiting
Nanjian Yi Autonomous County People's Hospital
Dali, Yunnan
Guangqin Li, 0872-8521180, njrsjsyg@126.com
- Recruiting
Yangbi County People's Hospital
Dali, Yunnan
Ye Chen, 0872-7520171, ybxrmyybgs@126.com
- Recruiting
Yongping County People's Hospital
Dali, Yunnan
Yuhua Zhang, 0872-6520579, ypxrmyyywk@126.com
- Recruiting
Dexing People's Hospital
Dexing, Jiangxi
Rong Huang, 0793-7973885, dxsrmyysbkc@126.com
- Recruiting
Hubei Minzu University Affiliated Minzu Hospital
Enshi, Hubei
Changhua Qu, MD, 010-83911991, 546473062@qq.com
- Recruiting
Fujian Medical University First Affiliated Hospital
Fuzhou, Fujian
Kunxin Lin, (0591)87982222, 837209190@qq.com
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Rongrong Gao, (0591)83357896, lwq2891902470@qq.com
- Recruiting
Fujian Minhou County Hospital
Fuzhou, Fujian
Bixia Zhang, 0591-22066063, youying0203@163.com
- Recruiting
Fuqing Hospital
Fuzhou, Fujian
Erqiang Wang, 0591-85156665, fqct2013@163.com
- Recruiting
Fuqing Second Hospital
Fuzhou, Fujian
Feihong Wang, 0591-62837358, zhuoxiaoliang@qq.com
- Recruiting
Fuzhou Changle District People's Hospital
Fuzhou, Fujian
Rongzeng Lin, MD, 0591-28801819, 729436334@qq.com
- Recruiting
Fuzhou Traditional Chinese Medicine Hospital
Fuzhou, Fujian
Wei Huang, 0591-87678520, fzszyy@126.com
- Recruiting
Lianjiang County General Hospital
Fuzhou, Fujian
Yan Zhang, 0591-26225676, ljxzyydb@163.com
- Recruiting
Luoyuan County Hospital
Fuzhou, Fujian
Wenbing Chen, 0591-26831120, 673449533@qq.com
- Recruiting
Minqing County General Hospital
Fuzhou, Fujian
Yongwen Liu, 0591- 22353627, mqly22462122@163.com
- Recruiting
Yongtai County Hospital
Fuzhou, Fujian
Zaijun He, 0591-24832295, 769497058@qq.com
- Recruiting
Guangchang County People's Hospital
Fuzhou, Jiangxi
Minghui Zhou, 0794-3622419, gcxrmyy@126.com
- Recruiting
Jinxi County People's Hospital
Fuzhou, Jiangxi
Guosheng Zhang, 0794-5292802, jxjxzhtch@sina.com
- Recruiting
Zixi County People's Hospital
Fuzhou, Jiangxi
Peng Zhao, 0794-5792050, zxxrmyy5792050@163.com
- Recruiting
Guangzhou Development District Hospital
Guangzhou, Guangdong
Shouxi Deng, 020-82087088, dshx2004@163.com
- Recruiting
Guangzhou He Xian Memorial Hospital
Guangzhou, Guangdong
Mei Qi, 020-34600859, 13432060824@163.com
- Recruiting
Jinan University First Affiliated Hospital
Guangzhou, Guangdong
Guan Min, MD, 8613602231780, 283227517@qq.com
- Recruiting
Yifeng County People's Hospital
Guangzhou, Guangdong
Shouxi Deng, 020-82087088, dshx2004@163.com
- Recruiting
Daming County Traditional Chinese Medicine Hospital
Handan, Hebei
Jintao Guo, 0310-6501121, 1677009778@qq.com
- Recruiting
Handan Central Hospital (East Campus)
Handan, Hebei
Tingting Wu, (0310)2112666, hdzhf2006@163.com
- Recruiting
Handan Fourth Hospital
Handan, Hebei
Fei Gao, 0310-5187819, hospital@hdsyy.com
- Recruiting
Linzhang County People's Hospital
Handan, Hebei
Linhua Li, 0310-7888201, jianshan0629@sina.com
- Recruiting
Quzhou County Hospital
Handan, Hebei
Fan Chen, 0310-8892251, 94386857@qq.com
- Recruiting
Fuchuan Yao Autonomous County Ethnic Medicine Hospital
Hezhou, Guangxi
Junguo He, 0774-7883669, fcxmzyyyrsk@126.com
- Recruiting
Hezhou Traditional Chinese Medicine Hospital
Hezhou, Guangxi
Muliang He, (0774)5139295, hzszyy@sina.com
- Recruiting
Zhaoping County People's Hospital
Hezhou, Guangxi
Hongyi Luo, MD, 0774-6682836, zpxrmyy@163.com
- Recruiting
Huangmei County People's Hospital
Huanggang, Hubei
Xinping Xu, 0713-3321130, 479096446@qq.com
- Recruiting
Xiajiang County People's Hospital
Ji’an, Jiangxi
Xiang Xu, 0796-3680556, xjxrmyy@126.com
- Recruiting
Xingan County People's Hospital
Ji’an, Jiangxi
Kewen Ge, MD, 0796-2602720, 903808253@qq.com
- Recruiting
Yongfeng County Traditional Chinese Medicine Hospital
Ji’an, Jiangxi
Jian Fu, MD, 0796-2519800, yfxzyy@126.com
- Recruiting
Jincheng First People's Hospital
Jinzhong, Shanxi
Junjie Song, 0354-2053396, jzyyjgb@163.com
- Recruiting
Xiyang County People's Hospital
Jinzhong, Shanxi
Pengfei Yue, 0354-4122105, xyyyljt@163.com
- Recruiting
Dean County People's Hospital
Jiujiang, Jiangxi
Ping'an Deng, 0792-4623007, 468104990@qq.com
- Recruiting
Dean County Traditional Chinese Medicine Hospital
Jiujiang, Jiangxi
Lan Wang, 0792-4362108, 479096446@qq.com
- Recruiting
Hukou County People's Hospital
Jiujiang, Jiangxi
Jianfei Ke, 0792-6330698, hkxrmyyrlzy@163.com
- Recruiting
Jiujiang First People's Hospital
Jiujiang, Jiangxi
Gang Li, (0792)8177120, 85593542@qq.com
- Recruiting
Pengze County People's Hospital
Jiujiang, Jiangxi
Aiyuan Xu, 15350131120, 479096446@qq.com
- Recruiting
Chenggong District People's Hospital
Kunming, Yunnan
Jizheng Zou, 0871-67479136, 1594086464@qq.com
- Recruiting
Jinning District People's Hospital
Kunming, Yunnan
Xiaoliu Li, 0871-67892717, 2383605775@qq.com
- Recruiting
Kunming Medical University Yan'an Hospital
Kunming, Yunnan
Haixin Chen, (0871)63211073, kmyayy@163.com
- Recruiting
Songming County People's Hospital
Kunming, Yunnan
Lihong Yang, 0871-67921258, 472668652@qq.com
- Recruiting
Yiliang First People's Hospital
Kunming, Yunnan
Hongbo Jiang, 0871-67539498, 814885816@qq.com
- Recruiting
Yunnan Provincial First People's Hospital
Kunming, Yunnan
Da Liu, (0871) 63639921, khyyyxll2061@163.com
- Recruiting
Liaocheng People's Hospital
Liaocheng, Shandong
Xiukai Guo, (0635)5099120, lcyiyuan@yahoo.com.cn
- Recruiting
Lichuan Traditional Chinese Medicine Hospital
Lichuan, Hubei
Yi Chen, MD, 0718-7266999, 94386857@qq.com
- Recruiting
Wenshui County People's Hospital
Lüliang, Shanxi
Haixia An, MD, 0358-3022256, wsyysbk2025@163.com
- Recruiting
Luoyang Central Hospital
Luoyang, Henan
Jiangwei Feng, MD, 8637963892008, lyhospital@sina.com
- Recruiting
Song County People's Hospital
Luoyang, Henan
Junfeng Dong, 0379-66319520, schol001@163.com
- Recruiting
Xin'an County People's Hospital
Luoyang, Henan
Yumin Yan, 0379-67281705, 386087680@qq.com
- Recruiting
Yichuan County People's Hospital
Luoyang, Henan
Yali Guo, 0379-68333209；(0379)68358939, ycxrmyy@126.com
- Recruiting
Lushan People's Hospital
Lushancun, Jiangxi
Ping Xiong, 0792-2666680, jxlsrmyy@126.com
- Recruiting
Linkou County People's Hospital
Mudanjiang, Heilongjiang
Zhenguo Xing, 0453-5938123, lkxdyrmyy@163.com
- Recruiting
Mudanjiang Second People's Hospital
Mudanjiang, Heilongjiang
Yongxu Yang, (0453)6592058, 49150914@qq.com
- Recruiting
Anyi County People's Hospital
Nanchang, Jiangxi
Muyin Dai, 0791-83416308, jxsayxrmyy@163.com
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi
Qingping Zhou, (0791)86895550, 13870965608@139.com
- Recruiting
Xinjian District People's Hospital
Nanchang, Jiangxi
Wang, 0791-83755699, ncgxyy@163.com
- Recruiting
Gutian County Hospital
Ningde, Fujian
Jie Chen, 0593-3882757, gtyyyb@163.com
- Recruiting
Putian Hanjiang District Hospital
Putian, Fujian
Wanfu He, MD, 0594-3880070, pthjyy@163.com
- Recruiting
The First People's Hospital of Qujing
Qujing, Yunnan, 655000
Sanxi Lei, MD, 08743311977, qjyyjjjc@126.com
- Recruiting
Fuyuan County People's Hospital
Qujing, Yunnan
xianghua Liu, 0874-4612125, 673449533@qq.com
- Recruiting
Shizong County People's Hospital
Qujing, Yunnan
Chao Liang, 0874-5759120, 1349591967@qq.com
- Recruiting
Poyang County People's Hospital
Shangrao, Jiangxi
Guobin Zhang, 13426637756, 236828997@qq.com
- Recruiting
Wannian County People's Hospital
Shangrao, Jiangxi
Fang, 0793-3832785, wnxrmyybgs2019@163.com
- Recruiting
Feicheng Hospital of Shandong Yiyang Health Group
Tai’an, Shandong
Changliang Chang, 0538-3120120, xb3158681@163.com
- Recruiting
Shanxi Provincial People's Hospital
Taiyuan, Shanxi
Tao Zhou, (0351)4960131, sxsrmyygcp@sina.com
- Recruiting
Xuanwei First People's Hospital
Xuanwei, Yunnan
Xiangxuan He, 0874-7883199, xwyyzcb@163.com
- Recruiting
Fengxin County People's Hospital
Yichun, Jiangxi
Aihua Yu, 0795-4622448, fxrmyy1946@163.com
- Recruiting
Shanggao County People's Hospital
Yichun, Jiangxi
Jun Yuan, MD, 0795-2516101, sgrmyygw@163.com
- Recruiting
Yima People's Hospital
Yima, Henan
Wenjing Zhao, 0398-5832968, zhmm0398@qq.com
- Recruiting
Yimei General Hospital
Yima, Henan
Zhang, 0398-5866586, ymzyyglk@163.com
- Recruiting
Yujiang District People's Hospital
Yingtan, Jiangxi
Mingfa Chen, 0701-5881267, ytyjrmyyrsk@163.com
- Recruiting
Yuxi Zhongshan Hospital
Yuxi, Yunnan
Qiqi Wei, MD, 0877-8866114, yxszsyy@163.com
- Recruiting
Zhangshu People's Hospital
Zhangshu, Jiangxi
Sizhen Ao, 0795-7332856, zsywk@sina.cn
- Recruiting
Dongshan County Hospital
Zhangzhou, Fujian
Xinping Xu, 0596-5836155, zzdsxygb@126.com
- Recruiting
Nanjing County Hospital
Zhangzhou, Fujian
Weiqi Xu, 0596-6035777, 7832845@qq.com
- Recruiting
Pinghe County Hospital
Zhangzhou, Fujian
Haibin Yan, 0596-5286186, 568588138@qq.com
- Recruiting
Xiage Health Center
Zhangzhou, Fujian
Suyan Huang, 0596-3082093, zzsyygcp@126.com
- Recruiting
Yunxiao County Hospital
Zhangzhou, Fujian
Shengbin Chen, 0596-6011856, 8538007@qq.com
- Recruiting
Yunxiao County Traditional Chinese Medicine Hospital
Zhangzhou, Fujian
Shengbin Chen, MD, 0596-8533215, 1329664919@qq.com
- Recruiting
Zhangpu County Hospital
Zhangzhou, Fujian
Wenhua Li, 0596-3221027, zpxyy_sbk@163.com
- Recruiting
Zhangpu County Traditional Chinese Medicine Hospital
Zhangzhou, Fujian
Jinyong Xu, 0596-3222502, 3222502@qq.com
- Recruiting
Zhangzhou Changtai District Hospital
Zhangzhou, Fujian
Wenchao Dai, 0596-8322188, ctxyyzwk@126.com
- Recruiting
Zhangzhou Fifth Hospital
Zhangzhou, Fujian
Changfu Lin, 0596-6718499, zzsdwyyrsk@163.com
- Recruiting
Zhangzhou Gulei Port Economic Development Zone First Hospital
Zhangzhou, Fujian
Linquan Zheng, 0596-6078107；0596-6078195, zzsyyglfy@163.com
- Recruiting
Zhangzhou Hospital Headquarters (High-Tech Campus)
Zhangzhou, Fujian
Weifeng Huang, (0596) 2082387, 2772174074@qq.com
- Recruiting
Zhangzhou Hospital
Zhangzhou, Fujian
Jingyu Chen, (0596)2082387, 2772174074@qq.com
- Recruiting
Zhangzhou Second Hospital
Zhangzhou, Fujian
Shaohua Lin, 0596-6522429, lhsdyyy@163.com
- Recruiting
Zhao'an County Hospital
Zhangzhou, Fujian
Yongbo Lin, 0596-3323260, zaxyyrsk@126.com
- Recruiting
Danchuan County Traditional Chinese Medicine Hospital
Zhoukou, Henan
Zhen Wang, 0394-3188633, dcxzyy@126.com
- Recruiting
Luyi Zhenyuan Hospital
Zhoukou, Henan
Yinliang Pan, 0394-7771808, zhenyuanyy@163.com
- Recruiting
Shenqiu County People's Hospital
Zhoukou, Henan
Yanling Li, 0394-5225095, zkzxjgb@163.com
- Recruiting
Zhoukou Central Hospital
Zhoukou, Henan
Yan Sun, (0394)96669, s165429@163.com
- Recruiting
Danchuan Central Hospital
Zhoukou, Hennan
Wenzhong Li, 0394-7726220, 1379975380@qq.com
About this study
Official title: Adjuvant Normobaric Hyperoxia in Acute Ischemic Stroke Patients Transferred for Thrombectomy
The primary objective of this study is to estimate the efficacy and safety of NBO on 3-month functional outcome after acute ischemic stroke
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
- Ischemic Stroke
- Being tested
- NBO, Control
- Keywords
- ischemic stroke, cerebral protection
- Medical subject headings
- 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 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, 1 year after randomization
Secondary outcomes (11)
Functional independence defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 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, 1 year after randomization
Excellent functional outcome, defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 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, 1 year after randomization
National Institutes of Health Stroke Scale (NIHSS)
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
Early neurological improvement
Neurological improvement is defined as a decrease of at least 4-point reduction in NIHSS score at 24 hours of randomization to baseline assessment
Measured: 24 hours after randomization
Alberta Stroke Program Early CT (ASPECT) score upon the Endovascular Thrombectomy (EVT) sites' admission
Alberta Stroke Program Early CT (ASPECT) score ranges from 0 to 10, with 10 being normal and 0 indicating complete MCA infarction
Measured: Day 0, Endovascular Thrombectomy (EVT) site admission
Change of Infarct volume at 24 hours from baseline
Both the infarct volume at 24 hours and the change of it from baseline will be analyzed
Measured: 24 (+/- 12) hours after randomization
EuroQol five dimensions questionnaire（EQ-5D）
The score ranges from 0 to 100, with higher scores indicating optimal health
Measured: 90 days, 1 year after randomization
Excellent functional outcome at day 5 (or discharge if earlier) defined as modified ranking scale (mRS) score of 0-1 at day 5 (or discharge if earlier)
The original modified ranking scale (mRS) score ranges from 0 to 6, with higher scores indicating a worse outcome. We use the dichotomozed mRS score to define the excellent functional outcome as mRS score of 0-1 at day 5 (or discharge if earlier).
Measured: Day 5 (or discharge if earlier) after randomization
Functional independence at day 5 (or discharge if earlier) defined as modified ranking scale (mRS) score of 0-2 at day 5 (or discharge if earlier)
The original modified ranking scale (mRS) score ranges from 0 to 6, with higher scores indicating a worse outcome. We use the dichotomozed mRS score to define the functional independence as mRS score of 0-2 at day 5 (or discharge if earlier).
Measured: Day 5 (or discharge if earlier) after randomization
Spontaneous or IV thrombolysis induced recanalization from baseline to Endovascular Thrombectomy (EVT) site arrival
Among patients who have related imaging from both the non-EVT and EVT sites
Measured: Day 0, Endovascular Thrombectomy (EVT) site admission
Barthel Index
The Barthel Index is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)
Measured: 90 days, 1 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start13 Dec 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- 1,500 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
- NCT06666764
- Sponsor's protocol ID
- AN-O2
- Acronym
- AN-O2
- Status last verified
- Dec 2025
- First submitted
- 27 Oct 2024
- Last updated
- 11 Dec 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Normobaric Hyperoxia in Acute Ischemic Stroke Patients Transferred for Thrombectomy
- ClinicalTrials.gov ID
- NCT06666764
- Acronym / sponsor ID
- AN-O2 / AN-O2
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, cerebral protection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 31 Oct 2024 (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 estimate the efficacy and safety of NBO on 3-month functional outcome after acute ischemic stroke
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 (10 listed)
- Age at least 18 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 in the last 3 months;
- Time from stroke onset (last seen well) to randomization is within 9 hours;
- (1) Baseline NIHSS score at 6 or more and Intracranial ICA or MCA-M1 or MCA-M2 dominant occlusion, with or without tandem cervical carotid stenosis or tandem cervical occlusion, confirmed by preoperative CTA (or MRA, DSA) and consistent with signs and symptoms; or (2) Baseline NIHSS score at 6 or more with a hyperdense MCA sign on non-contrast CT; or (3) Baseline NIHSS score at 12 or more;
Key exclusion criteria (15 listed)
- Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III or IV, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
- Respiratory rate <= 10 or >= 30 breaths per minute;
- Oxygen-dependence at baseline to maintain SaO2 > 95% or intubation at baseline;
- Seizure at stroke onset;
- Exhibiting symptoms of vomiting, or severe headache, or unconscious;
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 measured by modified Rankin scale (mRS) score
Time frame: 90 days, 1 year 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
11 secondary outcomes
Functional independence defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-2 at follow up
Time frame: 90 days, 1 year after randomization
Excellent functional outcome, defined as the proportion of patients with a modified Rankin scale (mRS) score of 0-1 at follow up
Time frame: 90 days, 1 year after randomization
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 24 hours after randomization
Early neurological improvement
Time frame: 24 hours after randomization
Alberta Stroke Program Early CT (ASPECT) score upon the Endovascular Thrombectomy (EVT) sites' admission
Time frame: Day 0, Endovascular Thrombectomy (EVT) site admission
Change of Infarct volume at 24 hours from baseline
Time frame: 24 (+/- 12) hours after randomization
EuroQol five dimensions questionnaire（EQ-5D）
Time frame: 90 days, 1 year after randomization
Excellent functional outcome at day 5 (or discharge if earlier) defined as modified ranking scale (mRS) score of 0-1 at day 5 (or discharge if earlier)
Time frame: Day 5 (or discharge if earlier) after randomization
Functional independence at day 5 (or discharge if earlier) defined as modified ranking scale (mRS) score of 0-2 at day 5 (or discharge if earlier)
Time frame: Day 5 (or discharge if earlier) after randomization
Spontaneous or IV thrombolysis induced recanalization from baseline to Endovascular Thrombectomy (EVT) site arrival
Time frame: Day 0, Endovascular Thrombectomy (EVT) site admission
Barthel Index
Time frame: 90 days, 1 year after randomization
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 11 Dec 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.
112 sites 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 Ischemic Stroke, run by Capital Medical University at 112 sites 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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites 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 measured by modified Rankin scale (mRS) score (time frame: 90 days, 1 year 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 11 Dec 2025.