Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 7:34 AM
Study NCT ID:
NCT05657457
Status:
TERMINATED
Last Update Posted:
2025-07-02
First Post:
2022-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'whyStopped': 'The interim analysis showed the potential harm of intra-arterial TNK.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2022-12-02', 'studyFirstSubmitQcDate': '2022-12-10', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of favorable functional outcome', 'timeFrame': 'Day 90', 'description': 'favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 3'}], 'secondaryOutcomes': [{'measure': 'proportion of patients with an improved modified thrombolysis in cerebral infarction score', 'timeFrame': 'immediately after intraarterial TNK administration or at the end of endovascular treatment'}, {'measure': 'the proportion of patients with modified Rankin Score (mRS) 0 to 1', 'timeFrame': 'Day 90', 'description': 'mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.'}, {'measure': 'the proportion of patients with modified Rankin Score (mRS) 0 to 2', 'timeFrame': 'Day 90', 'description': 'mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.'}, {'measure': 'ordinal distribution of modified Rankin Score (mRS)', 'timeFrame': 'Day 90', 'description': 'mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.'}, {'measure': 'change in modified Rankin Score (mRS) compared with premorbid mRS', 'timeFrame': 'Day 90', 'description': 'mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.'}, {'measure': 'change in National Institute of Health stroke scale (NIHSS)', 'timeFrame': '24 (-6/+24) hours', 'description': 'NIHSS scores range from 0 to 42, with higher scores indicating more severe neurological deficit'}, {'measure': 'proportion of early neurological improvement', 'timeFrame': '24 (-6/+24) hours', 'description': 'early neurological improvement is defined as a NIHSS decrease ≥4'}, {'measure': 'change in the cerebral circulation time', 'timeFrame': 'immediately after tenecteplase'}, {'measure': 'the occurrence rate of composite events of recurrent stroke, cardiovascular or cerebrovascular events', 'timeFrame': 'Day 90'}, {'measure': 'proportion of sympomatic intracranial hemorrhage', 'timeFrame': '24 (-6/+24) hours', 'description': 'sympomatic intracranial hemorrhage is defined as a NIHSS increase ≥4 caused by intracranial hemorrhage'}, {'measure': 'proportion of intraparenchymal hemorrhage', 'timeFrame': '24 (-6/+24) hours', 'description': 'intraparenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect'}, {'measure': 'the percentage of severe adverse events', 'timeFrame': '24 (-6/+24) hours'}, {'measure': 'cerebral edema', 'timeFrame': '24 (-6/+24) hours', 'description': 'cerebral edema was measure by the mount of midline shift of the brain on neuroimaging'}, {'measure': 'all-cause mortality', 'timeFrame': '10 days'}, {'measure': 'the number of tenecteplase infusions interrupted due to suspected active bleeding', 'timeFrame': 'during endovascular treatment (up to 2 hours)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': 'The potential benefit of intraarterial tenecteplase in acute basilar artery occlusion (BAO) patients with successful reperfusion following endovascular treatment (EVT) has not been studied. The current study aimed to explore the efficacy and safety of intraarterial tenecteplase in acute BAO patients with successful reperfusion after EVT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* Patients with basilar artery occlusion who received endovascular treatment within 24 hours of estimated time of stroke onset as per BASICS trial definition;\n* National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;\n* Successful recanalization (mTICI 2b-3) after endovascular treatment;\n* PC-ASPECTS ≥ 6 on CT;\n* Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;\n* Modified Rankin Scale score before stroke onset ≤ 3;\n* Signed informed consent by patient or their legally authorized representative.\n\nExclusion Criteria:\n\n* baseline PC ASPECTS \\< 5 on CT;\n* More than six retrieval attempts in the same vessel;\n* Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;\n* Coagulation disorders, systemic hemorrhagic diathesis, thrombocytopenia (\\<100000/mm3), or INR \\> 1.7;\n* Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;\n* After recanalization, severe and sustained (i.e., \\> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;\n* Patients with contraindication or allergic to any ingredient of drugs in our study\n* Pregnancy, plan to get pregnant or during lactation\n* The estimated life expectancy is less than 6 months due to other serious diseases;\n* Other conditions unsuitable for this clinical study assessed by researcher.'}, 'identificationModule': {'nctId': 'NCT05657457', 'briefTitle': 'Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT): a Prospective, Randomized, Open-label, Blinded-end Point, Multicenter Trial', 'orgStudyIdInfo': {'id': 'Y (2022) 185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TNK group', 'interventionNames': ['Drug: Tenecteplase']}, {'type': 'NO_INTERVENTION', 'label': 'control group'}], 'interventions': [{'name': 'Tenecteplase', 'type': 'DRUG', 'description': 'intra-arterial tenecteplase', 'armGroupLabels': ['TNK group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110840', 'city': 'Shenyang', 'country': 'China', 'facility': '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'}, 'collaborators': [{'name': 'Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Neurology', 'investigatorFullName': 'Hui-Sheng Chen', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}