Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-03-10 @ 6:48 AM
Study NCT ID:
NCT02273700
Status:
COMPLETED
Last Update Posted:
2016-08-24
First Post:
2014-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2014-10-22', 'studyFirstSubmitQcDate': '2014-10-22', 'lastUpdatePostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percent change in plasma protein/peptide profiles after one month of treatment versus before treatment', 'timeFrame': '1 month (between days 28 to 35) versus baseline (day 0)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Xarelto®', 'protein/peptide profiles'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The main objective of this pilot study is to investigate the protein / peptide plasma profiles before and after treatment with a direct anti-Xa (activated Factor 10) in patients with non-valvular atrial fibrillation to better understand the mechanisms of action of these molecules and perform exploratory analyses concerning proteins whose concentrations change after starting treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of patients in the cardiology department at the Nîmes University Hospital with non-valvular atrial fibrillation and who are candidates for treatment with a direct oral anticoagulant: Rivaroxaban (Xarelto®). Patients will be selected according to criteria designed to result in a homogeneous population (associated anticoagulants, etc., see below). For this study, patients must not have had a direct oral anti-Xa (activated Factor 10) in the 6 months preceding enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient was correctly informed about the study, its implementation, objectives, associated restrictions and patient rights\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 1 month of follow-up\n* The patient has non-valvular atrial fibrillation that was diagnosed within the last 3 months. Documentation of atrial fibrillation by a 12-lead ECG, an ECG rhythm strip, atrial fibrillation episode lasting at least 30 seconds.\n* The patient has a CHA2-DS2-VASc score = 1, that is to say the presence of at least one of the following risk factors: (1) congestive heart failure or moderate to severe systolic dysfunction of the left ventricle; (2) history of systolic blood pressure\\> 160 mmHg; (3) diabetes; (4) history of ischemic stroke or systemic embolism; (5) vascular disease (myocardial infarction, arterial disease); (6) age \\> 65 years; (7) female.\n* The patient will start Rivaroxaban (Xarelto®) at the Nîmes University Hospital\n\nExclusion Criteria:\n\n* The patient is participating in another interventional study\n* The patient has participated in another interventional study within the past three months\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* The patient is pregnant, parturient, or breastfeeding\n* Presence of a mechanical heart valve or valve disease\n* Patient who recieved another new direct oral anticoagulant other than Xarelto® in the previous three months'}, 'identificationModule': {'nctId': 'NCT02273700', 'acronym': 'Naco_Nîmes', 'briefTitle': 'Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Evaluation of Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention in Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'LOCAL/2014/GL-01'}, 'secondaryIdInfos': [{'id': '2014-A00516-41', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'the Study Population', 'description': 'The study population consists of patients in the cardiology department at the Nîmes University Hospital with non-valvular atrial fibrillation and who are candidates for treatment with a direct oral anticoagulant: Rivaroxaban (Xarelto®). Patients will be selected according to criteria designed to result in a homogeneous population (associated anticoagulants, etc., see below). For this study, patients must not have had a direct oral anti-Xa (activated Factor 10) in the 6 months preceding enrollment.\n\nIntervention: Rivaroxaban', 'interventionNames': ['Drug: Rivaroxaban']}], 'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'otherNames': ['(Xarelto®)'], 'description': 'Patients are observed during their first month of Rivaroxaban (Xarelto®) treatment, which is part of their routine care.', 'armGroupLabels': ['the Study Population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Géraldine Lavigne-Lissalde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}