Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT05965193
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke：Longterm Outcome (OPENS-3L)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1230}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2023-06-14', 'studyFirstSubmitQcDate': '2023-07-20', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Utility-weighted modified Rankin scale scores', 'timeFrame': '12 months±14 days after randomization', 'description': 'Utility-weighted modified Rankin scale scores'}], 'secondaryOutcomes': [{'measure': 'Cerebral infarct volume', 'timeFrame': '24-48hours after randomization', 'description': 'The infarct volume of cerebral infarct is evaluated by MRI'}, {'measure': 'modified Rankin Scale (mRS) score', 'timeFrame': '12 months±14 days after randomization', 'description': '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'}, {'measure': 'Good functional outcome', 'timeFrame': '12 months±14 days after randomization', 'description': 'Proportion of subjects with modified rankin scale (mRS) 0-2 at 12 months±14 days after randomization'}, {'measure': 'Excellent functional outcome', 'timeFrame': '6 months±14 days after randomization', 'description': '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'}, {'measure': 'Good functional outcome', 'timeFrame': '6 months±14 days after randomization', 'description': 'Proportion of subjects with modified rankin scale (mRS) 0-2 at 6 months±14 days after randomization'}, {'measure': 'modified Rankin Scale (mRS) score', 'timeFrame': '6 months±14 days after randomization', 'description': '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'}, {'measure': 'Scores assessed by National Institutes of Health Stroke Scale(NIHSS)', 'timeFrame': '4 ± 2 hours, 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': 'Barthel Index (BI)', 'timeFrame': '6 months±14 days,12 months±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': '6 months±14 days,12 months±14 days after randomization', 'description': 'The score ranges from 0 to 100, with higher scores indicating optimal health'}, {'measure': 'Stroke-related mortality', 'timeFrame': '12 months±14 days after randomization', 'description': 'Safety endpoint; the proportion of stroke related deaths in each group'}, {'measure': 'All-cause mortality', 'timeFrame': '12 months±14 days after randomization', 'description': 'Safety endpoint; the proportion of all patients who died in each group'}, {'measure': 'Symptomatic intracranial hemorrhage', 'timeFrame': '24 ± 6 hours after randomization', 'description': 'Proportion of subjects with symptomatic intracranial hemorrhage at 24 ± 6 hours after randomization (defined by ECASSII and ECASS III)'}, {'measure': 'Asymptomatic intracranial hemorrhage', 'timeFrame': '24 ± 6 hours after randomization', 'description': 'The incidence of asymptomatic intracranial hemorrhage at 24 ± 6 hours after randomization'}, {'measure': 'PH2 intracranial hemorrhage', 'timeFrame': '24 ± 6 hours after randomization', 'description': 'The incidence of PH2 intracranial hemorrhage at 24 ± 6 hours after randomization (according to SITS standards)'}, {'measure': 'Adverse events/serious adverse events', 'timeFrame': '24 ± 12 hours, 7 ± 2 days, 90± 7 days, 6 months±14 days,12 months±14 days after randomization', 'description': 'Safety endpoint; the proportion of adverse events/serious adverse events in each group'}, {'measure': 'Excellent functional outcome', 'timeFrame': '12 months±14 days after randomization', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age≥18 years;\n2. The time from onset to randomization is within 4.5 hours of onset;\n3. The clinical diagnosis is acute ischemic stroke (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);\n4. Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;\n5. Pre-stroke mRS score≤1 points;\n6. Informed consent from the patient or surrogate.\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);\n2. Past history of intracranial hemorrhage;\n3. Rapid neurological function improvement, NIHSS score less than 5 points;\n4. 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);\n5. 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);\n6. Intended to proceed endovascular treatment;\n7. Pregnant women, or planning to become pregnant during the trial;\n8. A history of severe head trauma or stroke within 3 months;\n9. A history of intracranial or spinal surgery within 3 months;\n10. A history of gastrointestinal or urinary bleeding within 3 weeks;\n11. two weeks of major surgery;\n12. Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;\n13. Active visceral bleeding;\n14. Intracranial tumors, large intracranial aneurysms;\n15. Aortic arch dissection was found;\n16. Severe, sustained hypertension (Systolic Blood Pressure \\>185 mmHg or Diastolic Blood Pressure \\>110 mmHg);\n17. Baseline blood glucose of \\<50mg/dL (2.78 mmol) or \\>400mg/dL (22.20 mmol);\n18. Oral warfarin anticoagulant with international normalized ratio(INR)\\>1.7 or PT\\>15 s;\n19. Heparin treatment was received within 24 h;\n20. Thrombin inhibitors or factor Xa inhibitors were used within 48 h;\n21. Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;\n22. Hereditary or acquired bleeding constitution;\n23. Onset with seizures;\n24. Severe liver and kidney dysfunction;\n25. Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;\n26. Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;\n27. Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen;\n28. Life expectancy \\< 1 year;\n29. Patients who could not complete the 90-day follow-up;\n30. Participation in other clinical trials within 3 months prior to screening;\n31. Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.'}, 'identificationModule': {'nctId': 'NCT05965193', 'briefTitle': 'Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke：Longterm Outcome (OPENS-3L)', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke：Longterm Outcome (OPENS-3L)', 'orgStudyIdInfo': {'id': 'OPENS-3L'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NBO group', 'description': 'Normobaric Hyperoxia combined with intravenous thrombolysis', 'interventionNames': ['Device: Normobaric Hyperoxia', 'Drug: Intravenous thrombolysis(rt-PA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Nasal oxygen combined with intravenous thrombolysis', 'interventionNames': ['Device: Nasal oxygen', 'Drug: Intravenous thrombolysis(rt-PA)']}], 'interventions': [{'name': 'Normobaric Hyperoxia', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['NBO group']}, {'name': 'Nasal oxygen', 'type': 'DEVICE', 'description': '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%.', 'armGroupLabels': ['Control group']}, {'name': 'Intravenous thrombolysis(rt-PA)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Control group', 'NBO group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xunming Ji, MD. PhD', 'role': 'CONTACT', 'email': 'jixunming@vip.163.com', 'phone': '861013120136877'}, {'name': 'Hetao Bian, MD. PhD', 'role': 'CONTACT', 'email': 'hetaobian@163.com', 'phone': '18266806812'}], 'facility': 'Xuan Wu Hospital，Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ji Xunming,MD,PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'Beijing Shijitan Hospital, Capital Medical University', 'class': 'OTHER'}, {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, {'name': "People's Hospital of Beijing Daxing District", 'class': 'OTHER'}, {'name': 'Tianjin Huanhu Hospital', 'class': 'OTHER'}, {'name': "Guizhou Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, {'name': "Jining First People's Hospital", 'class': 'OTHER'}, {'name': "Linyi People's Hospital", 'class': 'OTHER'}, {'name': 'Nanyang Central Hospital', 'class': 'OTHER'}, {'name': "Rizhao People's Hospital", 'class': 'OTHER'}, {'name': 'Zhumadian Central Hospital', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Nantong University', 'class': 'OTHER'}, {'name': 'The Second Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'Changsha Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ji Xunming,MD,PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}