Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
Study NCT ID:
NCT00157261
Status:
TERMINATED
Last Update Posted:
2013-10-29
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077785', 'term': 'Tenecteplase'}], 'ancestors': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1050}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2006-06'}, 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of this study is the 30-day survival rate', 'timeFrame': '30 days'}, {'measure': 'The co-primary endpoint of this study is hospital admission', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Return of spontaneous circulation (ROSC)', 'timeFrame': '30 days'}, {'measure': '24-hr survival', 'timeFrame': '24 hours'}, {'measure': 'Neurological and overall outcome at hospital discharge or at day 30, whichever came first', 'timeFrame': '30 days'}, {'measure': 'Symptomatic intracranial haemorrhage (ICH) up to hospital discharge or day 30, whichever came first', 'timeFrame': '30 days'}, {'measure': 'Major bleeds up to hospital discharge or day 30, whichever came first', 'timeFrame': '30 days'}]}, 'conditionsModule': {'conditions': ['Heart Arrest']}, 'referencesModule': {'references': [{'pmid': '19092151', 'type': 'DERIVED', 'citation': 'Bottiger BW, Arntz HR, Chamberlain DA, Bluhmki E, Belmans A, Danays T, Carli PA, Adgey JA, Bode C, Wenzel V; TROICA Trial Investigators; European Resuscitation Council Study Group. Thrombolysis during resuscitation for out-of-hospital cardiac arrest. N Engl J Med. 2008 Dec 18;359(25):2651-62. doi: 10.1056/NEJMoa070570.'}]}, 'descriptionModule': {'briefSummary': 'The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.', 'detailedDescription': 'The trial is a prospective, international, multi-centre, randomised (1:1), double-blind, parallel group comparison conducted for investigating the efficacy and safety of tenecteplase and placebo in patients with cardiac arrest of presumed cardiac origin.\n\nApproximately 1300 patients (two groups of 650 patients; tenecteplase or matching placebo) suffering from witnessed (by eye or ear) out-of-hospital cardiac arrest of presumed cardiac origin, who are treated with ALS-CPR will be randomised at approximately 40 study centres. Randomisation is done immediately after insertion of an IV line is established. Study drug application, as a single IV bolus over 5-10 seconds, should be done immediately after the first vasopressor application during the ALS-CPR procedure.\n\nPCI facilities will be required at all participating sites, i.e. hospitals receiving patients.\n\nStudy Hypothesis:\n\nThe primary aim of the trial is to demonstrate superiority in the intent-to-treat analysis of tenecteplase over placebo with regard to primary endpoint as the incidence of 30-day survival (30daysurv).\n\nComparison(s):\n\nGroup A (experimental; fibrinolytic treatment) Tenecteplase, as a single IV bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised ALS-CPR procedures according to the International CPR Guidelines.\n\nGroup B (reference) Placebo, as a single IV bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised ALS-CPR procedures according to the International CPR Guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients, indicated for pre-hospital ALS-CPR procedures\\* must fulfil the following inclusion criteria:\n\n* Age at least 18 years (known or estimated; no upper limit)\n* Out-of-hospital cardiac arrest of presumed cardiac origin (including recurrent cardiac arrest(s) after initial ROSC)\n* Witnessed (by eye and/or ear) cardiac arrest\n* BLS-CPR started within 10 min of onset (known or estimated time) and may be performed for up to 10 min, followed by ALS-CPR - or ALS-CPR started within 10 min of onset (known or estimated time)\n\nSubjects who meet any of the following criteria will be excluded from randomisation into the study:\n\n* In-hospital cardiac arrest\n* Cardiac arrest of presumed non-cardiac origin (e.g., drug overdose, carbon monoxide poisoning, drowning, hypothermia, exsanguination, electrocution, asphyxia, hypoxia, trauma, cerebrovascular accident)\n* Obvious significant internal bleeding\n* Known neurological impairment\n* Known coagulation disorder\n* Known pregnancy\n* Known current participation in any other clinical study\n* Known hypersensitivity to study medication\n* Institutionalised subjects (e.g., prisoner)\n* Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated'}, 'identificationModule': {'nctId': 'NCT00157261', 'briefTitle': 'Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Prospective, Randomised, Double-blind, Placebo-controlled, International, Multicentre, Parallel-group Comparison Trial Evaluating the Efficacy and Safety of Tenecteplase During Cardiopulmonary Resuscitation as Compared With Standard Treatment in Patients Suffering From Out-of-hospital Cardiac Arrest of Presumed Cardiac Origin Thrombolysis in Cardiac Arrest (TROICA) Trial', 'orgStudyIdInfo': {'id': '1123.18'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tenecteplase', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Univ.-Klinik f. 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Notfallmedizin', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Jan AV', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint-Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'AZ VUB', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'AZ Groeningen', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '7100', 'city': 'La Louvière', 'country': 'Belgium', 'facility': 'CHU de Tivoli', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuizen Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHR de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5000', 'city': 'Namur', 'country': 'Belgium', 'facility': 'CHR de Namur', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Hôpital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '78150', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Hôpital André Mignot', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Régional et Universitaire', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '77011', 'city': 'Melun', 'country': 'France', 'facility': 'Hôpital Marc Jacquet', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75743', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Hôpital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '38506', 'city': 'Voiron', 'country': 'France', 'facility': 'Hôpital Pierre Bazin', 'geoPoint': {'lat': 45.36471, 'lon': 5.5856}}, {'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitätsklinikum Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13504', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Humboldt-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'DRK Kliniken Westend', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '33604', 'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Städtische Kliniken Bielefeld gem. 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