Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT05534360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-09-09
First Post:
2022-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tenecteplase Treatment in Ischemic Stroke Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-06', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcome', 'timeFrame': 'Day 90', 'description': 'Modified Rankin score (mRS), score ranging from 0 (no symptom) to 6 (death).'}], 'secondaryOutcomes': [{'measure': 'Efficacy on functional independence (mRS ≤ 2)', 'timeFrame': 'Day 90', 'description': 'Rate of functional independence defined as a modified Rankin score 0-2'}, {'measure': 'Mortality rate', 'timeFrame': 'Day 90', 'description': 'Rate of all-cause mortality'}, {'measure': 'Early neurological outcome', 'timeFrame': 'Day 1', 'description': 'National Institutes of Health Stroke Scale (NIHSS) score after 24 hours, ranging from 0 (no symptom) to 42 (death)'}, {'measure': 'Incidence of haemorrhagic transformation', 'timeFrame': 'Day 1', 'description': 'Incidence of intracerebral haemorrhage on MRI or CT after 24 hours (±12 hours) according to the ECASS II classification.'}, {'measure': 'Incidence of symptomatic intracerebral haemorrhage (sICH)', 'timeFrame': 'Day 1', 'description': 'Incidence of sICH according to the SITS-MOST definition.'}, {'measure': 'Pre-thrombectomy recanalization rate', 'timeFrame': 'Day 1', 'description': 'Rate of complete or near complete recanalization, defined as an extended Thrombolysis in Cerebral Infarction (mTICI) 2b50/2b66/2c/3 before thrombectomy'}, {'measure': 'Final recanalization rate', 'timeFrame': 'Day 1', 'description': 'Rate of complete or near complete recanalization after'}, {'measure': 'Thrombolysis complication rate', 'timeFrame': 'Day 1', 'description': 'Rate of complications linked to intravenous thrombolysis with tenecteplase'}, {'measure': 'Thrombectomy complication rate', 'timeFrame': 'Day 1', 'description': 'Rate of patients with secondary decompressive craniectomy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Ischemic stroke', 'Thrombolytic therapy', 'Tenecteplase', 'Thrombectomy', 'Cerebrovascular Disorders', 'Brain diseases', 'Central Nervous Diseases', 'Nervous system Diseases', 'Vascular Diseases', 'Cardiovascular Diseases'], 'conditions': ['Stroke, Acute']}, 'referencesModule': {'references': [{'pmid': '38862134', 'type': 'DERIVED', 'citation': 'Gerschenfeld G, Turc G, Obadia M, Chausson N, Consoli A, Olindo S, Caroff J, Marnat G, Blanc R, Ben Hassen W, Seners P, Guillon B, Wiener E, Bourcier R, Yger M, Cho TH, Checkouri T, Gory B, Smadja D, Sibon I, Richard S, Piotin M, Eker OF, Pico F, Lapergue B, Alamowitch S; for ETIS and TETRIS study groups. Functional Outcome and Hemorrhage Rates After Bridging Therapy With Tenecteplase or Alteplase in Patients With Large Ischemic Core. Neurology. 2024 Jul 9;103(1):e209398. doi: 10.1212/WNL.0000000000209398. Epub 2024 Jun 11.'}], 'seeAlsoLinks': [{'url': 'https://institutducerveau-icm.org/fr/recherche-clinique/etudes-clinique/', 'label': 'Institutional study link'}]}, 'descriptionModule': {'briefSummary': 'The Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase', 'detailedDescription': 'Acute ischemic stroke management has considerably evolved over the last 20 years with the development of reperfusion treatments: intravenous thrombolysis (IVT) with alteplase, which is effective for AIS within 4.5 hours from symptoms onset and up to 9 hours in some cases; and mechanical thrombectomy (MT), in AIS with large vessel occlusion (LVO) within 24 hours from symptoms onset, either after IVT (bridging therapy) or alone in case of IVT contra-indication.\n\nAlteplase is a recombinant form of tissue plasminogen activator (rtPA) that, when bound to fibrin, will activate plasminogen and lead to fibrinolysis and clot dissolution. It is administered at a dose of 0.9 mg/kg (maximum 90 mg) with an intravenous bolus (10% of the dose) followed by a one-hour infusion. Tenecteplase is a genetically modified form of alteplase with greater fibrin specificity and a longer half-life, which allows a simpler one bolus administration at a dose of 0.25 mg/kg (maximum 25 mg).\n\nIn the Tenecteplase versus Alteplase before Endovascular Therapy for Ischemic Stroke (EXTEND-IA TNK) randomized clinical trial, which compared tenecteplase and alteplase in bridging therapy for AIS with LVO, tenecteplase achieved a better recanalization rate on arteriography before MT and a better functional outcome at 3 months. Following this trial, tenecteplase was added in stroke guidelines as an alternative to alteplase for IVT in bridging therapy. More recently, the Alteplase compared to Tenecteplase (ACT) trial has shown, in patients with LVO and non-LVO AIS, that tenecteplase is non-inferior to alteplase in terms of functional outcome. It is likely that in the near future tenecteplase will be added as an alternative to alteplase for AIS without LVO. However, while some "real-life" studies have been published on tenecteplase use for AIS with LVO, data on the general use of tenecteplase are still scarce.\n\nThe Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase. The main aim of this registry is to provide routine clinical care data on the use of tenecteplase for IVT for both AIS with and without LVO, in order to further characterize the safety and efficacy of tenecteplase for AIS. Additionally, we aim to use this registry which combines clinical and radiological data to explore other aspects related to AIS management in this cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive adult patients with an acute arterial ischemic stroke who received intravenous thrombolysis with tenecteplase in the participating centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and older\n* Confirmed acute arterial ischemic stroke on brain imaging (CT or MRI) within 270 minutes of symptoms onset or with perfusion CT or MRI criteria for an extended treatment window or wake-up strokes.\n* Intravenous thrombolysis with tenecteplase\n\nExclusion Criteria:\n\n* Contra-indication to intravenous thrombolysis\n* Intravenous thrombolysis with alteplase\n* Venous ischemic stroke'}, 'identificationModule': {'nctId': 'NCT05534360', 'acronym': 'TETRIS', 'briefTitle': 'Tenecteplase Treatment in Ischemic Stroke Registry', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Tenecteplase Treatment in Ischemic Stroke Registry', 'orgStudyIdInfo': {'id': 'APHP220465'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tenecteplase', 'description': 'All consecutive patients with an arterial acute ischemic stroke treated with intravenous thrombolysis with tenecteplase.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Gaspard Gerschenfeld, MD, PhD', 'role': 'CONTACT', 'email': 'gaspard.gerschenfeld@aphp.fr', 'phone': '1 42 16 24 75', 'phoneExt': '+33'}, {'name': 'Marion Yger, MD', 'role': 'CONTACT', 'email': 'marion.yger@aphp.fr', 'phone': '1 42 16 06 51', 'phoneExt': '+33'}], 'facility': 'Service des Urgences Cérébro-Vasculaires, Hôpitaux Universitaires Pitié-Salpêtrière et Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Sonia Alamowitch, MD', 'role': 'CONTACT', 'email': 'sonia.alamowitch@aphp.fr', 'phone': '1 71 97 06 51', 'phoneExt': '+33'}, {'name': 'Gaspard Gerschenfeld, MD, PhD', 'role': 'CONTACT', 'email': 'gaspard.gerschenfeld@aphp.fr', 'phone': '1 42 16 24 75', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Sonia Alamowitch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Gaspard Gerschenfeld, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}