Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT03887806
Status:
UNKNOWN
Last Update Posted:
2019-03-25
First Post:
2019-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cost Effectiveness Analysis of an Ancillary Study of the REMOTEV Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-21', 'studyFirstSubmitDate': '2019-03-20', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost-effectiveness analysis between 2 therapeutic strategies, Direct Oral Anticoagulants (Rivaroxaban) versus standard anticoagulant (AVK)', 'timeFrame': 'The period from November 1st, 2013 to July 01, 2015 will be examined', 'description': 'Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Venous', 'Thromboembolic', 'Direct Oral Anticoagulants', 'AOD', 'Cost analysis', 'REMOTEV', 'AVK', 'Pulmonary embolism'], 'conditions': ['Venous Thromboembolic Disease']}, 'descriptionModule': {'briefSummary': 'The implications of the medico-economic impact are essential in the choice of first-line therapists. The economic impact is an important criterion to recommend the privileged use of Direct Oral Anticoagulants (AOD) in first intention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with a diagnosis of MTEV: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Major patient whose age is ≥18 years\n* Patient with a diagnosis of MTEV: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations\n* Major patient included in the REMOTEV registry\n* Patient having accepted that his data recorded in the REMOTEV register be re-used for research and publication purposes\n\nCriteria of non-inclusion\n\n* Refusal to participate in the REMOTEV register\n* Patient who refused to have his data reused for research and publication purposes\n* Pregnant woman\n* Subjects under safeguard of justice Subject under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT03887806', 'briefTitle': 'Cost Effectiveness Analysis of an Ancillary Study of the REMOTEV Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': "Efficacy Cost Analysis: Retrospective Study on the REMOTEV Study's Ancillary Data", 'orgStudyIdInfo': {'id': '7158'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique STEPHAN, MD, PhD', 'role': 'CONTACT', 'email': 'Dominique.Stephan@chru-strasbourg.fr', 'phone': '33.3.69.55.09.52'}, {'name': 'Elena-Mihaela CORDEANU, MD', 'role': 'CONTACT', 'email': 'elena-mihaela.cordeanu@chru-strasbourg.fr', 'phone': '33 3 69 55 15 20'}, {'name': 'Dominique STEPHAN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Elena-Mihaela CORDEANU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sabrina GARNIER KEPKA, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sébastien GAERTNER, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service Des Maladies Vasculaires - Hta - Nhc', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Dominique STEPHAN, MD, PhD', 'role': 'CONTACT', 'email': 'dominique.stephan@chru-strasbourg.fr', 'phone': '33.3.69.55.09.52'}, {'name': 'Elena-Mihaela CORDEANU, MD', 'role': 'CONTACT', 'email': 'elena-mihaela.cordeanu@chru-strasbourg.fr', 'phone': '33 3 69 55 15 20'}], 'overallOfficials': [{'name': 'Dominique STEPHAN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}