Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
Study NCT ID:
NCT03889457
Status:
UNKNOWN
Last Update Posted:
2019-03-26
First Post:
2019-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
What Treatment for Patients With Phlebitis or Pulmonary Embolism ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2021-02-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-21', 'studyFirstSubmitDate': '2019-03-15', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to analyze patient treatment preferences in venous thromboembolic disease.', 'timeFrame': 'the time required for a consultation: 30 minutes', 'description': 'The primary outcome: To compare the proportion of patients choosing oral anticoagulation vs patients choosing injectable route.'}], 'secondaryOutcomes': [{'measure': 'compare patients choosing oral anticoagulation vs patients choosing an injectable route', 'timeFrame': 'the time required for a consultation: 30 minutes', 'description': 'proportions of patients choosing an oral anticoagulation vs. patients choosing an injectable pathway depending on the duration of treatment (3 months, 6 months or more),'}, {'measure': 'compare patients choosing oral anticoagulation vs patients choosing an injectable route', 'timeFrame': 'the time required for a consultation: 30 minutes', 'description': 'Identify factors influencing these choices, depending on the characteristics of the patient (history, age, gender, social environment, personal experience).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deep Vein Thrombosis', 'Superficial Vein Thrombosis', 'Anticoagulant', 'Patient Compliance', 'Preference', 'Venous Thrombosis', 'pulmonary embolism'], 'conditions': ['Venous Thrombosis or Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '34235186', 'type': 'DERIVED', 'citation': 'Laneelle D, Le Brun C, Mauger C, Guillaumat J, Le Pabic E, Omarjee L, Mahe G; SFMV VTE Study Group. Patient Characteristics and Preferences Regarding Anticoagulant Treatment in Venous Thromboembolic Disease. Front Cardiovasc Med. 2021 Jun 21;8:675969. doi: 10.3389/fcvm.2021.675969. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the "anticoagchoice" study is to analyze the preferences of people suffering from phlebitis, in terms of anticoagulant, to improve adherence to these treatments, to adapt the medical prescriptions.', 'detailedDescription': 'Venous thromboembolism (VTE) is the third leading cause of cardiovascular death, with an increase in annual incidence with age. With the advent of direct oral anticoagulants, the management of deep vein thrombosis and pulmonary embolism has evolved in recent years and these treatments are widely prescribed. There are studies comparing the different anticoagulant treatments used in venous thrombosis, which show no inferiority of treatment (injectable or oral) compared to others. Drug delivery modalities have been shown to affect adherence, and thus treatment efficacy. It seems fundamental to focus on patients\' drug preferences in VTE to ensure the best possible compliance. These preferences seem to depend on the personal history of each patient. In addition, no studies have been conducted on patient preferences for anticoagulant therapy for VTE: this is the goal of the "anticoagchoice" study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with deep vein thrombosis, superficial vein thrombosis, muscle vein thrombosis or pulmonary embolism, over 18 years of age in France (via the vascular doctors of the French Society of Vascular Médicine).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with deep vein thrombosis, superficial vein thrombosis, muscle vein thrombosis or pulmonary embolism, over 18 years of age.\n\nNo Exclusion Criteria'}, 'identificationModule': {'nctId': 'NCT03889457', 'acronym': 'AntiCoagChoice', 'briefTitle': 'What Treatment for Patients With Phlebitis or Pulmonary Embolism ?', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': "Patients' Choice in Terms of Anticoagulant Therapy in Venous Thrombo- Embolism Disease. AntiCoagChoice Study", 'orgStudyIdInfo': {'id': '35RC18_3002_AntiCoagChoice'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with venous thromboembolic disease', 'description': 'Patients with deep vein thrombosis, superficial or muscular vein thrombosis, pulmonary embolism, over 18 years of age.', 'interventionNames': ['Other: anticoagulation choice']}], 'interventions': [{'name': 'anticoagulation choice', 'type': 'OTHER', 'description': 'Type of anticoagulant chosen by the patient (oral or injectable).', 'armGroupLabels': ['Patients with venous thromboembolic disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume Mahe', 'role': 'CONTACT', 'email': 'guillaume.mahe@chu-rennes.fr'}], 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Cecile Ferragu', 'role': 'CONTACT', 'email': 'cecile.ferragu@chu-rennes.fr', 'phone': '02 99 28 25 55'}, {'name': 'direction de la recherche clinique', 'role': 'CONTACT', 'email': 'drc@chu-rennes.fr', 'phone': '02 99 28 25 55'}], 'overallOfficials': [{'name': 'Guillaume Mahe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'SFMV (French Society of Vascular Medicine)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}