Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-29 @ 8:34 AM
Study NCT ID:
NCT05486351
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2022-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083262', 'term': 'Embolic Stroke'}], 'ancestors': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples for levels of anticoagulant medications and/or INR testing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 318}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischemic stroke recurrence', 'timeFrame': '90 days', 'description': 'recurrence of ischemic stroke noticied by changes in neurologic status and supported by neuroimaging'}, {'measure': 'Symptomatic haemorrhagic transformation', 'timeFrame': '90 days', 'description': 'Symptomatic haemorrhagic transformation defined by the SITS criteria and supported by neuroimaging'}], 'secondaryOutcomes': [{'measure': 'Early ischemic stroke recurrence', 'timeFrame': 'Day 1 or day 7', 'description': 'Recurrence of ischemic stroke at days 1 or day 7'}, {'measure': 'Early symptomatic haemorrhagic transformation', 'timeFrame': 'Day 1 or day 7', 'description': 'Symptomatic transformation ocurring on day 1 or day 7'}, {'measure': 'Early radiologic haemorrhagic transformation', 'timeFrame': 'Day 1 or day 7', 'description': 'Parenchymal haematoma (type PH1 or PH2) on control neuroimaging performed at 24h (if mechanical thromectomy performed) and at day 7'}, {'measure': 'Systemic embolism', 'timeFrame': 'Day 1, day 7 or day 90', 'description': 'Clinical, radiologic or analytic findings that suggest an ischemic event (myocardic, renal, splenic, bowl or limb infarctions'}, {'measure': 'Major extracraneal haemorrhagic complication', 'timeFrame': 'Day 1, day 7 or day 90', 'description': 'intraocular, intraspinal, pericardic, intra-articular, intra-muscular with compartimental syndrome, retro-peritoneal bleeding that requires surgery or that causes death. Definition according to ISTH criteria'}, {'measure': 'Mortality', 'timeFrame': 'Day 7', 'description': 'Death'}, {'measure': 'Neurologic status', 'timeFrame': 'Day 90', 'description': 'NIHSS scale'}, {'measure': 'Functional status', 'timeFrame': 'Day 90', 'description': 'modified Rankin scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardioembolic Stroke', 'Anticoagulant Therapy', 'Stroke Recurrence', 'Haemorrhagic Transformation Stroke']}, 'descriptionModule': {'briefSummary': 'This is an observational, prospective, multicenter, cohort study in patients with cardioembolic stroke and previous oral or parenteral anticoagulant therapy. Patients in which anticoagulante therapy is mantained will be compared to those in which it is interrupted, in terms of stroke or systemic embolism and haemorrhagic transformation.', 'detailedDescription': 'Observational, prospective, multicenter, cohort study in patients with recent cardioembolic stroke (\\<24 hours) and previous oral or parenteral anticoagulant therapy (last dose recieved \\<24hours) . Patients in which anticoagulante therapy is mantained will be compared to those in which it is interrupted. The decision to mantain or interrumpt the anticoagulant therapy is made by the treating physician as hospital protocol. Stroke recurrence, haemorrhagic transformation at 90 days are evalauted and also complication during the hospitalization and functional outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute ischemic stroke, with a major cardioembolic source and previosly treated with oral or parental anticoagulants.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic stroke of less than 24 hours since beginning of symptoms or last seen normal\n* Mayor cardioembolic source (atrial fibrilation or flutter, mechanical heart valve prosthesis, recient miocardic infarction, rheumatic mitral valve stenosis, dilated cardiomyopathy, atrial myxoma, left ventricular focal akynesia.\n* Previous treatment with oral anticoagulants (vitamin K antagonists or direct oral anticoagulants), having received the last dose within the previous 24 hours. Treatment with intravenous or subcutaneos heparin is also valid.\n* Age \\>18 years-old\n* Signed informed consent (by patient or representative)\n\nExclusion Criteria:\n\n* History of Intracraneal or extracraneal haemorrhage that contraindicates anticoagulant therapy\n* Patients treated with intravenous thrombolysis as a reperfusion therapy\n* Intracraneal haemorrhage on initial CT scan\n* Health status with a short survival prevision\n* Patients in which a neurosurgery intervention could be indicated\n* Child-bearing woman or in breast-feeding period.'}, 'identificationModule': {'nctId': 'NCT05486351', 'acronym': 'KOALA-IS', 'briefTitle': 'Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Hospital Universitario La Paz'}, 'officialTitle': 'Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic', 'orgStudyIdInfo': {'id': 'PI-4056'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mantainance of anticoagulation therapy', 'description': 'Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is mantained', 'interventionNames': ['Other: Observation']}, {'label': 'Interruption of anticoagulation therapy', 'description': 'Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is interrupted.', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'Patients are observed for stroke or systemic embolism and haemorrhagic transformation', 'armGroupLabels': ['Interruption of anticoagulation therapy', 'Mantainance of anticoagulation therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Bichat Claude Bernard Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ricardo Rigual Bobillo', 'role': 'CONTACT'}], 'facility': 'Jimenez Diaz Fundation University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ricardo Rigual Bobillo, MD', 'role': 'CONTACT', 'email': 'ricardojaime.rigual@salud.madrid.org', 'phone': '917277444', 'phoneExt': '+34'}, {'name': 'Elena de Celis Ruiz, MD', 'role': 'CONTACT', 'email': 'elena.decelis.ruiz@idipaz.es', 'phone': '917277444', 'phoneExt': '+34'}], 'facility': 'La Paz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Ricardo Rigual Bobillo, MD', 'role': 'CONTACT', 'email': 'ricardojaime.rigual@salud.madrid.org', 'phone': '917277444', 'phoneExt': '+34'}, {'name': 'Elena de Celis Ruiz, MD', 'role': 'CONTACT', 'email': 'elena.decelis.ruiz@idipaz.es', 'phone': '917277444', 'phoneExt': '+34'}], 'overallOfficials': [{'name': 'Ricardo Rigual Bobillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Paz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Hospital Universitario La Paz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, {'name': 'Fundación Freno al ICTUS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}