Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01595958
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2012-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cyclosporine A in Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D000080942', 'term': 'Post-Cardiac Arrest Syndrome'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D016887', 'term': 'Cardiopulmonary Resuscitation'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 796}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2012-04-30', 'studyFirstSubmitQcDate': '2012-05-09', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sequential Organ Failure Assessment score (SOFA)', 'timeFrame': 'At 24 hours after hospital admission'}], 'secondaryOutcomes': [{'measure': 'Hospital admission with return of spontaneous circulation', 'timeFrame': 'At 24 hours following admission, at day 28, at hospital discharge (an average time frame of 7 days)'}, {'measure': 'Survival', 'timeFrame': 'At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)'}, {'measure': 'Good cerebral outcome', 'timeFrame': 'At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)', 'description': 'Glasgow Coma Scale and Cerebral Performance Categories'}, {'measure': 'All adverse events', 'timeFrame': 'until hospital discharge (an average time frame of 7 days)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac arrest', 'heart arrest', 'cyclosporine A', 'post cardiac arrest syndrome', 'protective agent', 'multiple organ failure', 'mitochondrial permeability transition pore', 'mitochondria', 'cardio-pulmonary resuscitation', 'cardioprotection', 'ischemia reperfusion', 'postconditioning'], 'conditions': ['Non Shockable Out of Hospital Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '27433815', 'type': 'RESULT', 'citation': 'Argaud L, Cour M, Dubien PY, Giraud F, Jossan C, Riche B, Hernu R, Darmon M, Poncelin Y, Tchenio X, Quenot JP, Freysz M, Kamga C, Beuret P, Usseglio P, Badet M, Anette B, Chaulier K, Alasan E, Sadoune S, Bobbia X, Zeni F, Gueugniaud PY, Robert D, Roy P, Ovize M; CYRUS Study Group. Effect of Cyclosporine in Nonshockable Out-of-Hospital Cardiac Arrest: The CYRUS Randomized Clinical Trial. JAMA Cardiol. 2016 Aug 1;1(5):557-65. doi: 10.1001/jamacardio.2016.1701.'}, {'pmid': '34116828', 'type': 'DERIVED', 'citation': 'Madelaine T, Cour M, Roy P, Vivien B, Charpentier J, Dumas F, Deye N, Bonnefoy E, Gueugniaud PY, Coste J, Cariou A, Argaud L. Prediction of Brain Death After Out-of-Hospital Cardiac Arrest: Development and Validation of the Brain Death After Cardiac Arrest Score. Chest. 2021 Jul;160(1):139-147. doi: 10.1016/j.chest.2021.01.056. Epub 2021 Jun 8.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesised that cyclosporine A administration at the onset of cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore, could prevent the post cardiac arrest syndrome and improve outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Witnessed out-of-hospital cardiac arrest\n* Non shockable cardiac rhythm\n\nExclusion Criteria:\n\n* Evidence of trauma\n* Evidence of pregnancy\n* Duration of no flow more than 30 minutes\n* Rapidly fatal underlying disease\n* Allergy to cyclosporin A'}, 'identificationModule': {'nctId': 'NCT01595958', 'acronym': 'CYRUS', 'briefTitle': 'Cyclosporine A in Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'CYclosporine A in Non-shockable Out-of-hospital Cardiac Arrest ResUScitation', 'orgStudyIdInfo': {'id': '2009.571'}, 'secondaryIdInfos': [{'id': '2009-015725-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclosporine A', 'description': 'Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation', 'interventionNames': ['Drug: Cyclosporine A', 'Procedure: cardio-pulmonary resuscitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'usual care of cardiac arrest', 'interventionNames': ['Procedure: cardio-pulmonary resuscitation']}], 'interventions': [{'name': 'Cyclosporine A', 'type': 'DRUG', 'description': 'Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation', 'armGroupLabels': ['Cyclosporine A']}, {'name': 'cardio-pulmonary resuscitation', 'type': 'PROCEDURE', 'description': 'usual care of cardiac arrest', 'armGroupLabels': ['Control', 'Cyclosporine A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Medical intensive care unit, Edouard Herriot Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Laurent ARGAUD, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupement Hospitalier Edouard Herriot,69437 Lyon Cedex 03'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}