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Clinical Trials in China / NCT06666764
Recruiting Phase 3

Normobaric Oxygen in AIS Transferred for EVT

NCT06666764 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Phase 3
Started
2024-12-13
Last updated
2025-12-11

Condition(s) studied

Ischemic Stroke

Investigational drug(s) / intervention(s)

NBOControl

NBO: NBO will be conducted with inhalation of 100% oxygen.

Control: Best medical care

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age at least 18 years old; 2. 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); 3. No prior stroke in the last 3 months; 4. Time from stroke onset (last seen well) to randomization is within 9 hours; 5. (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; 6. NIHSS score 0 or 1 in the section of level of consciousness; 7. No significant pre-stroke disability (pre-stroke mRS 0--1); 8. ASPECTS at least 6 on non-contrast CT; 9. Patient is planned for transfer to a EVT-capable hospital for EVT; 10. Signed informed consent from the patient or the legally authorized representative (LAR). Exclusion Criteria: 1. 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; 2. Respiratory rate \<= 10 or \>= 30 breaths per minute; 3. Oxygen-dependence at baseline to maintain SaO2 \> 95% or intubation at baseline; 4. Seizure at stroke onset; 5. Exhibiting symptoms of vomiting, or severe headache, or unconscious; 6. Rapidly improving neurological deficits or transient ischemic attack prior to consent; 7. Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal; 8. Evidence of intracranial tumor (except small meningioma) or arteriovenous malformation; 9. Woman of childbearing potential known to be pregnant or with a positive pregnancy test; 10. Life expectancy \< 90 days due to comorbidity; 11. Unlikely to complete the 90-day follow-up; 12. Participating in another clinical treatment trial, or completed participation within prior 30 days; 13. Receiving other cerebral protective agent (e.g., edaravone dexborneol, n-butylphthalide); 14. Evidence of acute intracranial hemorrhage on CT/MRI; 15. Significant mass effect with midline shift, defined as any deviation of midline structures such as the septum pellucidum, is observed on CT/MRI scans.

Primary outcome measure(s)

Trial sites (112)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Fujian Medical University First Affiliated Hospital Fuzhou Fujian Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting
Fujian Minhou County Hospital Fuzhou Fujian Recruiting
Fuqing Hospital Fuzhou Fujian Recruiting
Fuqing Second Hospital Fuzhou Fujian Recruiting
Fuzhou Changle District People's Hospital Fuzhou Fujian Recruiting
Fuzhou Traditional Chinese Medicine Hospital Fuzhou Fujian Recruiting
Lianjiang County General Hospital Fuzhou Fujian Recruiting
Luoyuan County Hospital Fuzhou Fujian Recruiting
Minqing County General Hospital Fuzhou Fujian Recruiting
Yongtai County Hospital Fuzhou Fujian Recruiting
Gutian County Hospital Ningde Fujian Recruiting
Putian Hanjiang District Hospital Putian Fujian Recruiting
Dongshan County Hospital Zhangzhou Fujian Recruiting
Nanjing County Hospital Zhangzhou Fujian Recruiting
Pinghe County Hospital Zhangzhou Fujian Recruiting
Xiage Health Center Zhangzhou Fujian Recruiting
Yunxiao County Hospital Zhangzhou Fujian Recruiting
Yunxiao County Traditional Chinese Medicine Hospital Zhangzhou Fujian Recruiting
Zhangpu County Hospital Zhangzhou Fujian Recruiting
Zhangpu County Traditional Chinese Medicine Hospital Zhangzhou Fujian Recruiting
Zhangzhou Changtai District Hospital Zhangzhou Fujian Recruiting
Zhangzhou Fifth Hospital Zhangzhou Fujian Recruiting
Zhangzhou Gulei Port Economic Development Zone First Hospital Zhangzhou Fujian Recruiting
Zhangzhou Hospital Headquarters (High-Tech Campus) Zhangzhou Fujian Recruiting
Zhangzhou Hospital Zhangzhou Fujian Recruiting
Zhangzhou Second Hospital Zhangzhou Fujian Recruiting
Zhao'an County Hospital Zhangzhou Fujian Recruiting
Guangzhou Development District Hospital Guangzhou Guangdong Recruiting
Guangzhou He Xian Memorial Hospital Guangzhou Guangdong Recruiting
Jinan University First Affiliated Hospital Guangzhou Guangdong Recruiting
Yifeng County People's Hospital Guangzhou Guangdong Recruiting
Fuchuan Yao Autonomous County Ethnic Medicine Hospital Hezhou Guangxi Recruiting
Hezhou Traditional Chinese Medicine Hospital Hezhou Guangxi Recruiting
Zhaoping County People's Hospital Hezhou Guangxi Recruiting
Cangzhou Central Hospital Cangzhou Hebei Recruiting
Dongguang County People's Hospital Cangzhou Hebei Recruiting
Xianxian Traditional Chinese Medicine Hospital Cangzhou Hebei Recruiting
Daming County Traditional Chinese Medicine Hospital Handan Hebei Recruiting

+ 72 more sites — see the full list on the official registry below.

More Capital Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06666764 on ClinicalTrials.gov ↗ ← All trials in China