Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-31 @ 3:09 AM
Study NCT ID:
NCT05728333
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke
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': 'D000077466', 'term': 'Tirofiban'}, {'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-27', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional independence', 'timeFrame': '90 days post-endovascular treatment', 'description': 'modified Rankin scale score of 0 to 2. (The modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endovascular thrombectomy', 'large vessel occlusion', 'intravenous thrombolysis', 'tirofiban'], 'conditions': ['Stroke, Acute Ischemic']}, 'referencesModule': {'references': [{'pmid': '33464335', 'type': 'RESULT', 'citation': 'Zi W, Qiu Z, Li F, Sang H, Wu D, Luo W, Liu S, Yuan J, Song J, Shi Z, Huang W, Zhang M, Liu W, Guo Z, Qiu T, Shi Q, Zhou P, Wang L, Fu X, Liu S, Yang S, Zhang S, Zhou Z, Huang X, Wang Y, Luo J, Bai Y, Zhang M, Wu Y, Zeng G, Wan Y, Wen C, Wen H, Ling W, Chen Z, Peng M, Ai Z, Guo F, Li H, Guo J, Guan H, Wang Z, Liu Y, Pu J, Wang Z, Liu H, Chen L, Huang J, Yang G, Gong Z, Shuai J, Nogueira RG, Yang Q; DEVT Trial Investigators. Effect of Endovascular Treatment Alone vs Intravenous Alteplase Plus Endovascular Treatment on Functional Independence in Patients With Acute Ischemic Stroke: The DEVT Randomized Clinical Trial. JAMA. 2021 Jan 19;325(3):234-243. doi: 10.1001/jama.2020.23523.'}, {'pmid': '35943471', 'type': 'RESULT', 'citation': 'RESCUE BT Trial Investigators; Qiu Z, Li F, Sang H, Luo W, Liu S, Liu W, Guo Z, Li H, Sun D, Huang W, Zhang M, Zhang M, Dai W, Zhou P, Deng W, Zhou Z, Huang X, Lei B, Li J, Yuan Z, Song B, Miao J, Liu S, Jin Z, Zeng G, Zeng H, Yuan J, Wen C, Yu Y, Yuan G, Wu J, Long C, Luo J, Tian Z, Zheng C, Hu Z, Wang S, Wang T, Qi L, Li R, Wan Y, Ke Y, Wu Y, Zhu X, Kong W, Huang J, Peng D, Chang M, Ge H, Shi Z, Yan Z, Du J, Jin Y, Ju D, Huang C, Hong Y, Liu T, Zhao W, Wang J, Zheng B, Wang L, Liu S, Luo X, Luo S, Xu X, Hu J, Pu J, Chen S, Sun Y, Jiang S, Wei L, Fu X, Bai Y, Yang S, Hu W, Zhang G, Pan C, Zhang S, Wang Y, Cao W, Yang S, Zhang J, Guo F, Wen H, Zhang J, Song J, Yue C, Li L, Wu D, Tian Y, Yang J, Lu M, Saver JL, Nogueira RG, Zi W, Yang Q. Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial. JAMA. 2022 Aug 9;328(6):543-553. doi: 10.1001/jama.2022.12584.'}]}, 'descriptionModule': {'briefSummary': 'In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or alteplase before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus alteplase for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.', 'detailedDescription': "Intravenous alteplase bridging with endovascular treatment (EVT) has been proven to be effective therapy in acute ischemic stroke patients due to large vessel occlusion (LVO). Several randomized controlled trials, aiming to explore the benefits and risks of intravenous alteplase prior to EVT in LVO stroke, have suggested that intravenous alteplase should not be omitted. Although intravenous alteplase results in successful reperfusion in approximately 10% to 20% of LVO patients, obviating the need for EVT, it has limitations. First, the time window for intravenous alteplase is narrow with strict indications and contraindications. Second, it may increase the risk of intracranial hemorrhage. Furthermore, alteplase is expensive. The above limitations lead to a very low proportion of patients who receive intravenous thrombolysis. Tirofiban is a selective IIb/IIIa receptor inhibitor, and it's effective in preventing thrombosis complications. Intravenous tirofiban has been increasingly used as an adjunctive treatment in acute ischemic stroke patients receiving EVT. However, a direct comparison between tirofiban and alteplase in LVO stroke has not been performed. We therefore conduct a randomized controlled trials to evaluate the efficacy and safety of intravenous tirofiban versus alteplase prior to EVT for acute ischemic stroke patients with LVO."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 years or older.\n2. Presenting with acute ischemic stroke symptom.\n3. Time from onset to hospital arrival:\n\n * (1) within 4.5 hours\n * (2) 4.5-9.0 hours, image inclusion criteria for the EXTEND trial must be met\n * (3) \\> 4.5 hours but within 24 hours, image inclusion criteria for the WAKE-UP trial must be met.\n4. Eligible for intravenous thrombolysis.\n5. Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, vertebrobasilar artery confirmed by CTA, MRA, or DSA.\n6. Informed consent obtained from patients or their legal representatives.\n\nExclusion Criteria:\n\n1. CT or MR evidence of hemorrhage (the presence of micro-bleeds is allowed);\n2. Contraindications of IV rt-PA or tirofiban;\n3. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;\n4. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;\n5. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;\n6. CT or MRI evidence of mass effect or intracranial tumor (except small eningioma);\n7. CT or MRI evidence of cerebral vasculitis;\n8. CTA or MRA evidence of intracranial arteriovenous malformations or aneurysms;\n9. Any terminal illness with life expectancy less than 6 months.'}, 'identificationModule': {'nctId': 'NCT05728333', 'acronym': 'ADJUVANT', 'briefTitle': 'Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Xinqiao Hospital of Chongqing'}, 'officialTitle': 'Intravenous Adjuvant With Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Acute Ischemic Stroke Patients With Large Vessel Occlusion: a Multicenter, Open Label, Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'ADJUVANT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tirofiban', 'description': 'Tirofiban will be administrated intravenously before endovascular thrombectomy.', 'interventionNames': ['Drug: Tirofiban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alteplase', 'description': 'Alteplase will be administrated intravenously before endovascular thrombectomy.', 'interventionNames': ['Drug: Alteplase']}], 'interventions': [{'name': 'Tirofiban', 'type': 'DRUG', 'otherNames': ['Tirofiban & EVT'], 'description': 'Intravenous tirofiban before endovascular thrombectomy.', 'armGroupLabels': ['Tirofiban']}, {'name': 'Alteplase', 'type': 'DRUG', 'otherNames': ['Alteplase & EVT'], 'description': 'Intravenous alteplase before endovascular thrombectomy.', 'armGroupLabels': ['Alteplase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongfei Sang', 'role': 'CONTACT', 'email': 'sanghongfei1988@163.com', 'phone': '+8613738132047'}], 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Hongfei Sang, Doctor', 'role': 'CONTACT', 'email': 'sanghongfei1988@163.com', 'phone': '+8613738132047'}, {'name': 'Zhongming Qiu, Doctor', 'role': 'CONTACT', 'email': 'qiuzhongmingdoctor@163.com', 'phone': '+8613236599269'}], 'overallOfficials': [{'name': 'Congguo Yin, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hangzhou First Hospital of Zhejiang University'}, {'name': 'Zhongming Qiu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The 903rd Hospital of PLA, China'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After the primary results was published', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhongming Qiu', 'investigatorAffiliation': 'Xinqiao Hospital of Chongqing'}}}}