Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT06045156
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2023-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic 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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1084}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Symptomatic intracranial hemorrhage', 'timeFrame': 'within 24 hours of completion of study drug infusion, hospitalization', 'description': 'Symptomatic intracranial hemorrhage is defined according to the ECASS Classification'}, {'measure': 'Hemorrhagic transformation', 'timeFrame': '24 hours after IVT, hospitalization', 'description': 'defined according to the ECASS Classification'}], 'primaryOutcomes': [{'measure': 'Proportion of patients of modified Rankin Scale (mRS)≤1', 'timeFrame': '90±7 days', 'description': 'mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients of mRS≤2', 'timeFrame': '90±7 days', 'description': 'mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome'}, {'measure': 'Distribution of mRS', 'timeFrame': '90±7 days', 'description': 'mRS depicts functional outcome of stroke, which ranges from 0-6'}, {'measure': 'National Institute of Health stroke scale (NIHSS)', 'timeFrame': '24 hours after IVT, 7 days', 'description': 'National Institute of Health stroke scale (NIHSS) ranges from 0 to 42, a low value represents a better outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute ischemic stroke', 'intravenous thrombolysis', 'tirofiban'], 'conditions': ['Acute Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '38196129', 'type': 'DERIVED', 'citation': 'Guo ZN, Zhang KJ, Zhang P, Qu Y, Abuduxukuer R, Nguyen TN, Chen HS, Yang Y. Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial. Eur Stroke J. 2024 Jun;9(2):510-514. doi: 10.1177/23969873231225069. Epub 2024 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT', 'detailedDescription': 'Nearly half of acute ischemic stroke patients underwent intravenous thrombolysis (IVT) failed to achieve excellent functional outcome. Some studies reported that early administrated tirofiban, a selective glycoproteinⅡb/Ⅲa receptor inhibitor, may greatly improve the outcome of patients who received IVT, however they only recruited small sample size.\n\nThus, the investigators design early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT) trial, aiming to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age≥18 years old;\n2. Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset;\n3. Total National Institute of Health stroke scale (NIHSS)≥4 or single limb motor item score≥2, and total NIHSS≤15 after IVT;\n4. Tirofiban or placebo treatment can be initiated within 6h after IVT;\n5. mRS score before onset≤ 1;\n6. Intracranial hemorrhage is ruled out by CT head after IVT;\n7. Systolic blood pressure before enrollment≤ 160mmHg;\n\nExclusion Criteria:\n\n1. Received or plan to undergo bridge therapy;\n2. Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area);\n3. Atrial fibrillation or suspected cardiac embolism;\n4. Accompanied by epileptic seizures;\n5. Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment;\n6. Active bleeding or tendency to bleed after receipt of intravenous thrombolysis;\n7. Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year;\n8. Severe renal or liver insufficiency; ALT or AST\\>3 times of the upper limit of normal value or above; creatinine clearance rate\\<30 mL/min, creatinine\\>200μmol/L；\n9. Life expectancy less than 3 months;\n10. Pregnant or lactating women;\n11. Known allergy to tirofiban;\n12. Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.;\n13. Patients who are unwilling to be followed up or likely to have poor treatment compliance;\n14. Other situations that the researcher deems unsuitable for inclusion in the study.'}, 'identificationModule': {'nctId': 'NCT06045156', 'briefTitle': 'Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'ADVENT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tirofiban group', 'description': 'Tirofiban infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT', 'interventionNames': ['Drug: Tirofiban']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Tirofiban simulant group', 'description': 'Tirofiban simulant infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT', 'interventionNames': ['Drug: Tirofiban simulant']}], 'interventions': [{'name': 'Tirofiban', 'type': 'DRUG', 'description': 'Tirofiban is a selective glycoproteinⅡb/Ⅲa receptor inhibitor, which inhibits platelet aggregation and thrombi formation', 'armGroupLabels': ['Tirofiban group']}, {'name': 'Tirofiban simulant', 'type': 'DRUG', 'description': 'Tirofiban simulant is placebo packed the same style as tirofiban', 'armGroupLabels': ['Tirofiban simulant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Yang, MD, PhD', 'role': 'CONTACT', 'email': 'doctoryangyi@163.com', 'phone': '13756661217'}], 'facility': 'The first hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Dean of First Hospital of Jilin University', 'investigatorFullName': 'Yi Yang', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}