Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 5:58 PM
Study NCT ID:
NCT06010628
Status:
RECRUITING
Last Update Posted:
2025-08-21
First Post:
2023-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077785', 'term': 'Tenecteplase'}], 'ancestors': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1440}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2023-08-20', 'studyFirstSubmitQcDate': '2023-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of modified Rankin Scale (mRS) 0-1', 'timeFrame': '90±7 days', 'description': 'The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome'}], 'secondaryOutcomes': [{'measure': 'proportion of modified Rankin Scale (mRS) 0-2', 'timeFrame': '90±7 days', 'description': 'The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome'}, {'measure': 'ordinal distribution of modified Rankin Scale (mRS)', 'timeFrame': '90±7 days', 'description': 'The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome'}, {'measure': 'change in National Institute of Health stroke scale (NIHSS) score', 'timeFrame': '24 (-6/+12) hours', 'description': 'the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.'}, {'measure': 'change in National Institute of Health stroke scale (NIHSS) score', 'timeFrame': '10±2 days', 'description': 'the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.'}, {'measure': 'occurrence of early neurological improvement (ENI)', 'timeFrame': '24 (-6/+12) hours', 'description': 'ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score'}, {'measure': 'new stroke or other vascular event(s)', 'timeFrame': '90±7 days'}, {'measure': 'all-cause mortality', 'timeFrame': '90±7 days'}, {'measure': 'symptomatic intracranial hemorrhage (sICH)', 'timeFrame': '24 (-6/+12) hours', 'description': 'sICH is defined as parenchymal hematoma type 1 or 2 (PH1 or PH2), remote intraparenchymal hematoma (RIH), subarachnoid hemorrhage, or intraventricular hemorrhage on head CT/MRI scan causally associated with clinically significant neurological deterioration (NIHSS score ≥4 point increase) in the opinion of the clinical investigator or independent safety monitor.'}, {'measure': 'intracranial hemorrhage', 'timeFrame': '24 (-6/+12) hours', 'description': 'any evidence of bleeding on the head CT scan, classified by the Heidelberg Bleeding Classification'}, {'measure': 'major systemic bleeding event', 'timeFrame': '24 (-6/+12) hours'}, {'measure': 'any bleeding event', 'timeFrame': '24 (-6/+12) hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thrombolysis'], 'conditions': ['Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': 'To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 year\n* Acute ischemic stroke confirmed by non-contrast computed tomography and use of CTA for assessment of LVO as determined by local investigators;\n* The time from last known well to treatment: 4.5 - 6 hours;\n* NIHSS ≥ 4 at randomization;\n* First stroke onset or past stroke without obvious neurological deficit (mRS≤1);\n* Uncertainty over the benefits and risks of thrombolysis by researcher;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Pre-stroke disability (mRS≥2);\n* Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion;\n* Any contraindication to intravenous thrombolysis: Obvious head injury or stroke within 3 months; Subarachnoid or intracranial hemorrhage; History of intracranial hemorrhage; Intracranial tumor, arteriovenous malformation or aneurysm; Intracranial or spinal cord surgery within 3 months; Myocardial infarction within 3 months; Major surgery within 1 month; Gastrointestinal or urinary tract hemorrhage within the previous 30 days; Arterial puncture at a noncompressible site within the previous seven days; Active internal hemorrhage; Coagulation abnormalities: platelet count of \\<100000/mm3; Aortic arch dissection; Heparin therapy within 24 hours; Infective endocarditis; Oral warfarin is being taken and INR\\>1.6 or APTT abnormal; Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg; Blood glucose \\< 50 mg/dl (2.7mmol/L); Neurological deficit after epileptic seizures;\n* Pregnancy;\n* Allergy to test drugs;\n* Comorbidity with other serious diseases;\n* Participating in other clinical trials within 3 months;\n* Patients not suitable for the study considered by researcher.'}, 'identificationModule': {'nctId': 'NCT06010628', 'briefTitle': 'Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2): a Prospective, Randomized, Open Label, Blinded Endpoint, and Multi-center Study', 'orgStudyIdInfo': {'id': 'Y (2023) 144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tenecteplase group', 'description': 'intravenous thrombolysis with tenecteplase', 'interventionNames': ['Drug: Tenecteplase']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'standard stroke care based on national guideline', 'interventionNames': ['Drug: Tenecteplase']}], 'interventions': [{'name': 'Tenecteplase', 'type': 'DRUG', 'description': 'intravenous tenecteplase (0.25 mg/kg, a single bolus over 5 to 10 seconds, a maximum of 25 mg).', 'armGroupLabels': ['Control group', 'Tenecteplase group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110840', 'city': 'Shenyang', 'state': 'None Selected', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi-Han Wang', 'role': 'CONTACT', 'email': 'wangyihan34732512@163.com', 'phone': '+862428897524'}], 'facility': 'Hui-Sheng Chen', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '110016', 'city': 'Shenyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui-Sheng Chen, Ph.D.', 'role': 'CONTACT', 'email': 'chszh@aliyun.com', 'phone': '+86 13352452086'}], 'facility': 'Department of Neurology, General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Hui-Sheng Chen', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}