Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT06078995
Status:
UNKNOWN
Last Update Posted:
2023-10-12
First Post:
2023-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China
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'}, {'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'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'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-09', 'studyFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2023-10-09', 'lastUpdatePostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients with symptomatic intracranial hemorrhage within 36 hours', 'timeFrame': '36 hours', 'description': 'Clinical deterioration or neurological decline causing an increase in NIHSS score of ≥4 points due to intracranial hemorrhage confirmed by brain imaging'}], 'secondaryOutcomes': [{'measure': '90 days mRS 0-1', 'timeFrame': 'at 90±7 days', 'description': 'modified Rankin Scale score measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.'}, {'measure': '90 days mRS shift', 'timeFrame': 'at 90±7 days', 'description': 'a shift analysis of the distribution of modified Rankin Scale score which measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.'}, {'measure': 'discharge mRS', 'timeFrame': 'at discharge (up to 30 days)', 'description': 'modified Rankin Scale score measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.'}, {'measure': '24 hours NIHSS score', 'timeFrame': 'at 24 hours after receiving thrombolysis', 'description': 'The NIH Stroke Scale/Score (NIHSS) quantifies stroke severity based on weighted evaluation findings. Scores range from 0 to 42, with higher scores indicating greater severity.'}, {'measure': 'discharge NIHSS score', 'timeFrame': 'at discharge (up to 30 days)', 'description': 'The NIH Stroke Scale/Score (NIHSS) quantifies stroke severity based on weighted evaluation findings. Scores range from 0 to 42, with higher scores indicating greater severity.'}, {'measure': 'Rate of patients with any systematic bleeding', 'timeFrame': 'during hospital stay (up to 30 days)', 'description': 'Rate of patients with any systematic bleeding requiring blood infusion during hospital stay reflecting short term safety outcome'}, {'measure': 'Rate of patients with 90 days mortality', 'timeFrame': 'at 90±7 days', 'description': 'Rate of patients with all-cause mortality within 90 days reflecting safety outcome'}, {'measure': 'Rate of patients with any intracranial hemorrhage', 'timeFrame': 'during hospital stay (up to 30 days)', 'description': 'Rate of patients with any intracranial hemorrhage without significant neurological deterioration on the brain imaging reflecting short term safety outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intravenous thrombolysis', 'Tenecteplase'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients within 4.5 hours of symptom onset in a real-world clinical setting.', 'detailedDescription': 'Recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has the logistic advantage of a single bolus infusion over recombinant tissue plasminogen activator (rt-PA) which needs a 1-hour infusion. The non-inferiority of rhTNK-tPA compared to rt-PA was proved by two recent randomized controlled clinical trials but the evidence is lacking regarding the real-world effectiveness and safety of rhTNK-tPA.\n\nThis is a multi-center, observational, retrospective study that enrolled acute ischemic stroke patients treated with rhTNK-tPA thrombolysis in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'acute ischemic stroke patients treated with rhTNK-tPA or rt-PA in China.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all acute ischaemic stroke patients who met eligibility for thrombolysis with intravenous alteplase or TNK and presenting within 4·5 hours of symptom onset.\n\nExclusion Criteria:\n\n* variables with a missing rate \\> 40%'}, 'identificationModule': {'nctId': 'NCT06078995', 'acronym': 'TTT-AIS CHINA', 'briefTitle': 'Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China a Real-world, Multicenter, Retrospective, Controlled Study', 'orgStudyIdInfo': {'id': '20230726'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tenecteplase', 'description': 'acute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase', 'interventionNames': ['Drug: Tenecteplase']}, {'label': 'alteplase', 'description': 'acute ischemic stroke patients who receive intravenous thrombolysis with alteplase', 'interventionNames': ['Drug: Alteplase']}], 'interventions': [{'name': 'Tenecteplase', 'type': 'DRUG', 'otherNames': ['rhTNK-tPA'], 'description': 'Thrombolysis wtih rhTNK-tPA', 'armGroupLabels': ['Tenecteplase']}, {'name': 'Alteplase', 'type': 'DRUG', 'otherNames': ['rt-PA'], 'description': 'Thrombolysis wtih rt-PA', 'armGroupLabels': ['alteplase']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Cheng', 'role': 'CONTACT'}], 'facility': 'Xin Chen', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qiang Dong, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'qiang_dong163@163.com', 'phone': '86-021-52887142'}], 'overallOfficials': [{'name': 'Qiang Dong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Keshiketeng Banner Traditional Chinese Medicine Mongolian Medicine Hospitalorem Ipsum', 'class': 'UNKNOWN'}, {'name': 'Nanshi Hospital of Nanyang', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Ningbo University', 'class': 'NETWORK'}, {'name': 'Jilin Liuhe Hospital', 'class': 'UNKNOWN'}, {'name': "Shenyang Fifth People's hospital", 'class': 'UNKNOWN'}, {'name': 'Shanghai East Hospita', 'class': 'UNKNOWN'}, {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, {'name': "Shanghai Fifth People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Shanghai Pudong Gongli hospital', 'class': 'UNKNOWN'}, {'name': 'Shanghai Neuromedical Center', 'class': 'UNKNOWN'}, {'name': "Shanghai Fourth People's Hospital", 'class': 'UNKNOWN'}, {'name': "Shanghai Pudong People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Shanghai Putuo District Center Hospital', 'class': 'OTHER'}, {'name': 'Shenyang Fushun general hospital of mining bureau', 'class': 'UNKNOWN'}, {'name': 'Yantai Affliated Hosiptal of Binzhou Medical University', 'class': 'UNKNOWN'}, {'name': "Shanghai Ninth People's Hospital Huangpu Branch", 'class': 'UNKNOWN'}, {'name': 'Shanghai Deji Hospital', 'class': 'UNKNOWN'}, {'name': 'Ruijin Hospital Luwan Branch', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qiang Dong', 'investigatorAffiliation': 'Huashan Hospital'}}}}