Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02258204
Status:
UNKNOWN
Last Update Posted:
2016-02-24
First Post:
2014-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine for Thrombolysis in Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'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'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2014-10-06', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral infarction growth on diffusion weighted magnetic resonance imaging between admission and day 1.', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'National Institute of Health Stroke Scale', 'timeFrame': 'day 0, day 1, day 7 and day 90'}, {'measure': 'Modified Rankin Scale', 'timeFrame': 'day 90'}, {'measure': 'Infarction volume on diffusion weighted magnetic resonance imaging', 'timeFrame': 'day 1'}, {'measure': 'T2-weighted Fluid Attenuated Inversion Recovery Imaging infarct volume', 'timeFrame': 'day 90'}, {'measure': 'Symptomatic intracerebral hemorrhage and/or death', 'timeFrame': 'day 90'}, {'measure': 'Arterial patency', 'timeFrame': 'day 0 (before and after thrombectomy) and day 1', 'description': 'Arterial patency will be assessed with the Thrombolysis in Cerebral Infarction (TICI) Score on day 0 before and after thrombectomy (digital subtraction angiography) and day 1 (magnetic resonance angiography).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cerebral Infarct', 'Thrombolysis', 'Tissue-type plasminogen activator', 'Neuroprotection', 'Anesthetic agent', 'Magnetic resonance imaging'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '11135617', 'type': 'BACKGROUND', 'citation': 'Nicole O, Docagne F, Ali C, Margaill I, Carmeliet P, MacKenzie ET, Vivien D, Buisson A. The proteolytic activity of tissue-plasminogen activator enhances NMDA receptor-mediated signaling. Nat Med. 2001 Jan;7(1):59-64. doi: 10.1038/83358.'}, {'pmid': '21817137', 'type': 'BACKGROUND', 'citation': 'Gakuba C, Gauberti M, Mazighi M, Defer G, Hanouz JL, Vivien D. Preclinical evidence toward the use of ketamine for recombinant tissue-type plasminogen activator-mediated thrombolysis under anesthesia or sedation. Stroke. 2011 Oct;42(10):2947-9. doi: 10.1161/STROKEAHA.111.620468. Epub 2011 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'KETA trial is a nonprofit, double-blind, randomized, controlled pilot trial with aiming to determine if co-administration of ketamine with recombinant of tissue type plasminogen activator (tPA) for thrombolysis in acute ischemic stroke compared with tPA co-administered with placebo, decreases cerebral infarction growth in diffusion weighted imaging between admission and day 1. Eligibility applies to patients with symptomatic ischemic stroke seen within 4.5 h of onset with middle cerebral artery or distal internal carotid artery occlusion, no contraindication to intravenous tPA-mediated thrombolysis and eligible to endovascular treatment of stroke (i.e. thrombectomy). The study has been designed to have 80% power to detect a 80% decrease of infarct volume growth in the tPA-ketamine group at a two-sided type I error rate of 5%. For this purpose, at least 25 patients per arm should be enrolled.', 'detailedDescription': 'Rationale - Tissue-type plasminogen activator (tPA) is a double-sided molecule, with beneficial effect in acute ischemic stroke due to its intravascular fibrinolytic activity but with potential deleterious effect due to its ability to potentiate neuronal N-methyl-D-aspartate (NMDA) receptor signalling (Nicole et al., 2001). Co-administration of sub-anesthetic dose of ketamine - a non-competitive inhibitor of NMDA receptor - was shown to improve efficacy of tPA-mediated thrombolysis following stroke in rodents (Gakuba et al, 2011).\n\nAims - To assess efficacy and safety of co-administration of ketamine with tPA compared with tPA-placebo infusion in patients with acute ischemic stroke.\n\nSample size estimates -With 25 patients per group, the trial has a 80% probability of detecting a 80% decrease of infarct volume growth in the tPA-ketamine group compared with the tPA-placebo group on day 1 after admission at a two-sided type I error rate of 5%.\n\nStudy outcomes - The primary efficacy outcome is cerebral infarction growth on diffusion weighted imaging between admission and day 1. The primary safety measure is mortality and/or symptomatic intracerebral hemorrhage rate at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sudden focal neurological deficit attributable to acute ischemic stroke.\n* Age between 18 and 85.\n* Time from symptom onset less than 4.5 hours.\n* NIHSS score between 7 and 20.\n* Informed consent for participation.\n* Ketamine can be administered within 15 minutes after onset of tPA infusion.\n* MRI-based AIS diagnosis.\n* Middle cerebral (M1 or M2 segment) and/or distal internal carotid artery occlusion.\n* No intracranial hemorrhage on MRI.\n* Patient eligible for thrombectomy.\n\nExclusion Criteria:\n\n* Contraindication to IV tPA treatment.\n* Contraindication to ketamine.\n* Contraindication to MRI.\n* Contraindication to intravascular iodinated contrast media.\n* Consciousness level \\>1 on question 1a of NIHSS.\n* Pre-stroke mRS ≥3.\n* Concomitant medical illness that would interfere with outcome assessments and follow-up (e.g. advanced cancer or respiratory disease).\n* Previous participation in this trial or current participation in another investigational drug trial.\n* Infarct volume on diffusion weighted MRI more than 100 mL.'}, 'identificationModule': {'nctId': 'NCT02258204', 'acronym': 'KETA', 'briefTitle': 'Ketamine for Thrombolysis in Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': "Effets de la kétamine en Association Avec le Rt-PA au Cours de l'Infarctus cérébral Aigu: étude Pilote contrôlée randomisée en Double Aveugle Avec critère de Jugement Radiologique", 'orgStudyIdInfo': {'id': 'KETA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'tPA-placebo', 'description': 'tPA infusion : 0.9 mg/kg (90 mg maximum), 10% of the total dose is administered as an initial IV bolus dose over 1 minute and the remainder of the dose is infused over 60 minutes.\n\nSaline infusion : 0.15 mL/kg IV bolus (maximum 15 mL) followed by an IV infusion of 0.15 mL/kg over 60 minutes (maximum 15 mL).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'tPA-ketamine', 'description': 'tPA infusion : 0.9 mg/kg (90 mg maximum), 10% of the total dose is administered as an initial IV bolus dose over 1 minute and the remainder of the dose is infused over 60 minutes.\n\nKetamine infusion : 0.15 mg/kg IV bolus (maximum 15 mg) followed by an IV infusion of 0.15 mg/kg over 60 minutes (maximum 15 mg).', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'Co-administration of subanesthetic dose of ketamine with tPA for thrombolysis in acute ischemic stroke.', 'armGroupLabels': ['tPA-ketamine']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['tPA-placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel Touzé, MD PhD', 'role': 'CONTACT', 'email': 'touze-e@chu-caen.fr', 'phone': '+33231064624'}], 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'collaborators': [{'name': "Société Française d'Anesthésie Réanimation", 'class': 'UNKNOWN'}, {'name': 'Fondation NRJ', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Emmanuel TOUZE', 'investigatorAffiliation': 'University Hospital, Caen'}}}}