Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-30 @ 4:45 AM
Study NCT ID:
NCT04681651
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2020-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normobaric Hyperoxia Combined With Endovascular Treatment in Acute Ischemic Stroke (OPENS-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 282}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-04', 'studyFirstSubmitDate': '2020-12-06', 'studyFirstSubmitQcDate': '2020-12-19', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rankin Scale (mRS) score', 'timeFrame': '90 ± 14 days after randomization', 'description': 'the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)'}], 'secondaryOutcomes': [{'measure': 'Cerebral infarct volume', 'timeFrame': '24-48h after randomization', 'description': 'The infarct volume of cerebral infarct is evaluated by MRI or CT'}, {'measure': 'The proportion of good prognosis', 'timeFrame': '90 ± 14 days after randomization', 'description': 'defined by mRS 0-2'}, {'measure': 'The proportion of functional independence', 'timeFrame': '90 ± 14 days after randomization', 'description': 'defined by mRS 0-1'}, {'measure': 'The proportion of severe disability', 'timeFrame': '90 ± 14 days after randomization', 'description': 'defined by mRS 4-6'}, {'measure': 'Scores assessed by National Institutes of Health Stroke Scale(NIHSS)', 'timeFrame': '24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization', 'description': 'Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits'}, {'measure': 'The proportion of neurological function improvement', 'timeFrame': '24 ± 6 hours after randomization', 'description': '≥ 4 point reduction in NIHSS score from baseline'}, {'measure': 'Successful vessel recanalization', 'timeFrame': 'Immediately after procedure', 'description': 'Successful vessel recanalization is defined by eTICI 2b/2c/3 on final angiogram. Extended treatment in cerebral ischaemia (eTICI) score range from 0 to 3, with higher scores indicating better reperfusion'}, {'measure': 'Vessel recanalization', 'timeFrame': '24 ± 6 hours after randomization', 'description': 'Vessel recanalization is evaluated by CTA or MRA and assessed by AOL grades. Arterial Occlusive Lesion (AOL) range from 0 to 3, with higher scores indicating better recanalization'}, {'measure': 'Arterial oxygen partial pressure', 'timeFrame': 'after 4 hours of oxygen therapy', 'description': 'Laboratory indicators, obtained by arterial blood gas analysis'}, {'measure': 'Barthel Index (BI)', 'timeFrame': '90 ± 14 days after randomization', 'description': 'the BI is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)'}, {'measure': 'EuroQol five dimensions questionnaire（EQ-5D）', 'timeFrame': '90 ± 14 days after randomization', 'description': 'The score ranges from 0 to 100, with higher scores indicating optimal health'}, {'measure': 'Days of hospitalization', 'timeFrame': '90 ± 14 days after randomization', 'description': 'Length of stay in hospital'}, {'measure': 'All-cause mortality', 'timeFrame': '90 ± 14 days after randomization', 'description': 'Safety endpoint; the proportion of all patients who died in each group'}, {'measure': 'Serious adverse events', 'timeFrame': '90 ± 14 days after randomization', 'description': 'Safety endpoint; the proportion of serious adverse events in each group'}, {'measure': 'Stroke-related mortality', 'timeFrame': '90 ± 14 days after randomization', 'description': 'Safety endpoint; the proportion of stroke related deaths in each group'}, {'measure': 'Oxygen-related adverse events', 'timeFrame': '90 ± 14 days after randomization', 'description': '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'}, {'measure': 'Adverse events of special interest', 'timeFrame': '90 ± 14 days after randomization', 'description': 'Safety endpoint; the proportion of adverse events of special interest in each group, including malignant brain edema, perioperative myocardial infarction, and acute heart failure'}, {'measure': 'Symptomatic intracranial hemorrhage', 'timeFrame': '24 ± 6 hours after randomization', 'description': 'Safety endpoint; according to ECASS II definition'}, {'measure': 'Any intracranial hemorrhage', 'timeFrame': '24 ± 6 hours after randomization', 'description': 'Safety endpoint; the proportion of any intracranial hemorrhage in each group'}, {'measure': 'Early neurological deterioration (END)', 'timeFrame': '24 ± 6 hours after randomization', 'description': 'Safety endpoint; defined as ≥4 point increase in NIHSS score from baseline'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': '24 ± 6 hours after randomization', 'description': 'Safety endpoint; vital signs'}, {'measure': 'Heart rate', 'timeFrame': '24 ± 6 hours after randomization', 'description': 'Safety endpoint; vital signs'}, {'measure': 'Respiratory rate', 'timeFrame': '24 ± 6 hours after randomization', 'description': 'Safety endpoint; vital signs'}, {'measure': 'Oxygen saturation', 'timeFrame': '24 ± 6 hours after randomization', 'description': 'Safety endpoint; vital signs'}, {'measure': 'PH of arterial blood gas analysis', 'timeFrame': 'after 4 hours of oxygen therapy', 'description': 'Safety endpoint'}, {'measure': 'PaCO2 of arterial blood gas analysis', 'timeFrame': 'after 4 hours of oxygen therapy', 'description': 'Safety endpoint'}, {'measure': 'Lactic acid of arterial blood gas analysis', 'timeFrame': 'after 4 hours of oxygen therapy', 'description': 'Safety endpoint'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Normobaric hyperoxia', 'Endovascular treatment', 'Acute ischemic stroke'], 'conditions': ['Stroke, Acute', 'Neuroprotection']}, 'referencesModule': {'references': [{'pmid': '39922675', 'type': 'DERIVED', 'citation': 'Li W, Lan J, Wei M, Liu L, Hou C, Qi Z, Li C, Jiao L, Yang Q, Chen W, Liu S, Yue X, Dong Q, Yuan H, Gao Z, Wu X, Wen C, Li T, Jiang C, Li D, Chen Z, Shi J, Shi W, Yuan J, Qin Y, Li B, Fisher M, Feng W, Liu KJ, Ji X; OPENS-2 Investigators. Normobaric hyperoxia combined with endovascular treatment for acute ischaemic stroke in China (OPENS-2 trial): a multicentre, randomised, single-blind, sham-controlled trial. Lancet. 2025 Feb 8;405(10477):486-497. doi: 10.1016/S0140-6736(24)02809-5.'}]}, 'descriptionModule': {'briefSummary': 'The current endovascular treatment has increased the recanalization rate to more than 90%. Even so, the prognosis rate of stroke is still less than 50%. Our previous research confirmed that the neuroprotective effect of Normobaric Hyperoxia (NBO) from multiple perspectives. However, the clinical study on NBO was not satisfactory, which might be due to the absence of vascular recanalization therapy. Therefore, The investigators conducted this RCT study to further explore the Efficacy and safety of NBO combined with endovascular treatment in patients with acute ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral inclusion criteria\n\n1. It conforms to the indications for endovascular thrombectomy\n2. 18 ≦ Age ≦ 80 years old.\n3. The clinical symptoms and signs are consistent with acute anterior circulation large vessel occlusion; 10≤NIHSS≤20；\n4. (Level of consciousness) NIHSS score 0 or 1;\n5. The time from onset to randomization is within 6 hours of onset;\n6. The mRS score before stroke is 0-1;\n7. Patient and family members sign informed consent. Image inclusion criteria\n\n1\\. Preoperative CT or MR or DSA angiography found large vessel occlusion (internal carotid artery or middle cerebral artery M1 segment) that were consistent with symptoms and signs; 2. ASPECT score ≥ 6 points 3. \\<1/3 MCA area involvement (confirmed by CT or MRI)\n\nExclusion Criteria:\n\n* General exclusion criteria\n\n 1. Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;\n 2. Seizures at stroke onset;\n 3. Intracranial hemorrhage;\n 4. Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;\n 5. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR \\> 3.0 or PTT \\> 3 times normal;\n 6. Platelet count of less than 100,000 per cubic millimeter;\n 7. Severe hepatic or renal dysfunction;\n 8. Severe, sustained hypertension (Systolic Blood Pressure \\>185 mmHg or Diastolic Blood Pressure \\>110 mmHg)\n 9. Baseline blood glucose of \\<50mg/dL (2.78 mmol) or \\>400mg/dL (22.20 mmol)\n 10. Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;\n 11. \\>3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2) 95% as per current stroke management guidelines;\n 12. Medically unstable;\n 13. Life expectancy\\<90 days;\n 14. Patients who could not complete the 90-day follow-up;\n 15. Evidence of intracranial tumor;\n 16. Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;\n 17. Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen.\n 18. A history of severe allergies to contrast agents;\n 19. There are any other conditions that are not suitable for endovascular treatment.\n\nImage exclusion criteria\n\n1. CTA/MRAshows excessive bending of blood vessels, which may hinder the delivery of the device;\n2. Suspected cerebrovascular inflammation based on medical history and CTA/MRA;\n3. Suspected aortic dissection based on medical history and CTA/MRA\n4. CTA/MRA confirmed multi-vascular area occlusion (such as bilateral anterior circulation or anterior/posterior circulation), or bilateral infarction or multi- regional infarction;\n5. CTA/MRAconfirmed moyamoya disease or moyamoya syndrome;\n6. CT/MRI confirmed the obvious effect of midline shift\n7. CT/MRI confirmed the presence of intracranial tumors'}, 'identificationModule': {'nctId': 'NCT04681651', 'briefTitle': 'Normobaric Hyperoxia Combined With Endovascular Treatment in Acute Ischemic Stroke (OPENS-2)', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'A Randomized Controlled Trial Assessing the Efficacy and Safety of Normobaric Hyperoxia for Acute Ischemic Stroke Patients Undergoing Endovascular Treatment', 'orgStudyIdInfo': {'id': 'OPENS-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NBO group', 'description': 'Normobaric Hyperoxia combined with endovascular mechanical thrombectomy', 'interventionNames': ['Drug: Normobaric Hyperoxia', 'Procedure: Endovascular Thrombectomy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Inhale air placebo plus endovascular mechanical thrombectomy', 'interventionNames': ['Drug: Sham Normobaric Hyperoxia', 'Procedure: Endovascular Thrombectomy']}], 'interventions': [{'name': 'Normobaric Hyperoxia', 'type': 'DRUG', 'otherNames': ['NBO'], 'description': 'Within 6 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.', 'armGroupLabels': ['NBO group']}, {'name': 'Sham Normobaric Hyperoxia', 'type': 'DRUG', 'otherNames': ['Sham NBO'], 'description': 'For Sham NBO group, Patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 1l/min using the same mask 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%；', 'armGroupLabels': ['Control group']}, {'name': 'Endovascular Thrombectomy', 'type': 'PROCEDURE', 'otherNames': ['EVT'], 'description': 'EVT is the international guidelines for the treatment of acute ischemic stroke with lage vessel occlusion.', 'armGroupLabels': ['Control group', 'NBO group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuan Wu Hospital，Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xunming Ji, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tianjin Huanhu Hospital', 'class': 'OTHER'}, {'name': 'Shengli Oilfield Hospital', 'class': 'OTHER'}, {'name': "Beijing Fengtai You'anmen Hospital", 'class': 'UNKNOWN'}, {'name': 'Jiujiang University Affiliated Hospital', 'class': 'OTHER_GOV'}, {'name': 'Zhangzhou Municipal Hospital of Fujian Province', 'class': 'OTHER'}, {'name': 'Baotou Central Hospital', 'class': 'OTHER'}, {'name': 'Luoyang Central Hospital', 'class': 'OTHER'}, {'name': 'Nanyang Central Hospital', 'class': 'OTHER'}, {'name': 'Qingdao Central Hospital', 'class': 'OTHER'}, {'name': "The Third People's Hospital of Jinan", 'class': 'UNKNOWN'}, {'name': "Rizhao People's Hospital", 'class': 'OTHER'}, {'name': "Anyang People's Hospital", 'class': 'UNKNOWN'}, {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, {'name': 'Dalian Municipal Central Hospital', 'class': 'OTHER'}, {'name': 'Zhoukou Central Hospital', 'class': 'OTHER'}, {'name': 'Nanshi Hospital of Nanyang', 'class': 'UNKNOWN'}, {'name': "The second Nanning People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Zhumadian Central Hospital', 'class': 'OTHER'}, {'name': 'Taizhou Hospital', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ji Xunming,MD,PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}