Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-25 @ 8:08 AM
Study NCT ID:
NCT03197194
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2017-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015356', 'term': 'Retinal Artery Occlusion'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'id': 'D001241', 'term': 'Aspirin'}], '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'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-06-22', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual acuity (VA) improvement after treatment', 'timeFrame': '1 month', 'description': 'Improvement of the VA is defined by a gain of 15 letters or more on the ETDRS VA chart or ordinal scale'}], 'secondaryOutcomes': [{'measure': 'Tolerance', 'timeFrame': '3 months', 'description': 'Number, type and grade of severity of adverse drug reactions'}, {'measure': 'Proportion of blindness patients after treatment', 'timeFrame': '1 month', 'description': 'Blindness is defined according to WHO revised categories of visual impairment, as VA \\< 1/20 (\\< 20/400 or \\> 1.3 log.MAR) or visual field \\< 10.'}, {'measure': 'Visual field', 'timeFrame': '3 months', 'description': 'Visual field at 3 months.'}, {'measure': 'Time course of VA on ETDRS chart or ordinal scale', 'timeFrame': '3 months'}, {'measure': 'Time-to-treatment administration impact on VA evolution.', 'timeFrame': '1 month', 'description': 'Mean VA improvement according to the time between onset of sign and treatment administration'}, {'measure': 'Global disability (modified Rankin scale) after treatment', 'timeFrame': '3 months'}, {'measure': 'Quality of life related to vision (NEI-VFQ-25) after treatment', 'timeFrame': '3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central retinal artery occlusion', 'visual acuity', 'visual field', 'mRs', 'NEI-VFQ-25'], 'conditions': ['Central Retinal Artery Occlusion']}, 'referencesModule': {'references': [{'pmid': '41109232', 'type': 'DERIVED', 'citation': 'Preterre C, Gaultier A, Obadia M, Vignal C, Mourand I, Plat J, Sablot D, Gaudron M, Rodier G, Godeneche G, Urbanczyk C, Marc G, Massardier E, Adam S, Boulanger M, Marcel S, Mechtouff L, Ronziere T, Calviere L, Godard-Ducceschi S, Barbin L, Lebranchu P, Guillon B; THEIA collaborators. Intravenous alteplase versus oral aspirin for acute central retinal artery occlusion within 4.5 h of severe vision loss (THEIA): a multicentre, double-dummy, patient-blinded and assessor-blinded, randomised, controlled, phase 3 trial. Lancet Neurol. 2025 Nov;24(11):909-919. doi: 10.1016/S1474-4422(25)00308-4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged up to 18 years\n* CRAO diagnosis by fundoscopic examination or non-mydriatic retinophotography (NMR) performed by an ophthalmologist.\n* Blindness defined according to WHO classification as visual acuity \\<1/20 (20/400).\n* Treatment intervention should be initiated by a stroke team as quickly as possible and within 4.5 hours from symptom onset.\n* No clinical (e.g headache with jaw claudication or scalp tenderness, no temporal pulse) or laboratory evidence (elevated CRP) of giant cell arteritis\n* No clinical or radiological evidence of stroke within the last 3 months.\n* Patients covered by health care insurance (social security)\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* Symptoms onset more than 4.5 h prior to infusion start or undetermined time of symptom onset.\n* Minor VA deficit or VA rapidly improving before start of infusion.\n* CRAO without foveal ischemia.\n* Other retinal vascular disease: occlusion of branch of the CRA without significant VA loss, occlusion of the retinal vein, proliferative diabetic retinopathy or any other severe retinopathy.\n* Clinical or laboratory evidence of temporal arteritis.\n* Evidence of ICH or ischemic stroke on the pre-administration CT scan or MRI.\n* Pregnant or lactating women\n* Minors\n* Adults under guardianship or trusteeship\n* Any contraindication to alteplase\n* Any contraindication to aspirin'}, 'identificationModule': {'nctId': 'NCT03197194', 'acronym': 'THEIA', 'briefTitle': 'A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion', 'orgStudyIdInfo': {'id': 'RC17_0061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A : Alteplase', 'description': 'Intravenous injection of Alteplase and one tablet of placebo', 'interventionNames': ['Drug: Alteplase', 'Drug: Placebo Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B : Acetylsalicylic Acid', 'description': 'one tablet of Acetylsalicylic Acid and one dose of IV placebo', 'interventionNames': ['Drug: acetylsalicylic acid', 'Drug: placebo IV']}], 'interventions': [{'name': 'Alteplase', 'type': 'DRUG', 'otherNames': ['Actilyse'], 'description': 'alteplase administered as an intravenous infusion (0.9 mg/kg; maximum dose 90 mg): 10% given as an IV bolus, followed immediately by the remaining given as an IV infusion over 1 hour.', 'armGroupLabels': ['A : Alteplase']}, {'name': 'acetylsalicylic acid', 'type': 'DRUG', 'otherNames': ['Aspirin'], 'description': 'one tablet of aspirin 300 mg', 'armGroupLabels': ['B : Acetylsalicylic Acid']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'otherNames': ['Placebo aspirin'], 'description': "One placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid", 'armGroupLabels': ['A : Alteplase']}, {'name': 'placebo IV', 'type': 'DRUG', 'otherNames': ['Placebo Actilyse'], 'description': 'IV saline solution (0.9 %):10 mL in a syringe administered over 1 minute, followed by 50 mL as an infusion over 1 hour', 'armGroupLabels': ['B : Acetylsalicylic Acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Annecy', 'country': 'France', 'facility': 'CH Annecy Genevois', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '73000', 'city': 'Chambéry', 'country': 'France', 'facility': 'CH métropole Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '85000', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '17019', 'city': 'La Rochelle', 'country': 'France', 'facility': 'CH de La Rochelle', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'Lyon', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06001', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation Ophtalmologique Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Perpignan', 'country': 'France', 'facility': 'Ch Perpignan', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '44606', 'city': 'Saint-Nazaire', 'country': 'France', 'facility': 'CH de Saint Nazaire', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Vannes', 'country': 'France', 'facility': 'CH Vannes', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}], 'overallOfficials': [{'name': 'Benoit GUILLON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}