Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT00171769
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation Feasibility Certoparin Trial - AFFECT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C403769', 'term': 'certoparin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events'}]}, 'conditionsModule': {'conditions': ['Persistent Nonvalvular Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '18322636', 'type': 'RESULT', 'citation': 'Tebbe U, Oeckinghaus R, Appel KF, Heuer H, Haake H, Eggers E, Seidel K, Adams J, Harenberg J. AFFECT: a prospective, open-label, multicenter trial to evaluate the feasibility and safety of a short-term treatment with subcutaneous certoparin in patients with persistent non-valvular atrial fibrillation. Clin Res Cardiol. 2008 Jun;97(6):389-96. doi: 10.1007/s00392-008-0644-y. Epub 2008 Mar 5.'}]}, 'descriptionModule': {'briefSummary': 'This trial is designed to provide data about feasibility and safety of short-term treatment with the low-molecular-weight heparin certoparin in patients with persistent nonvalvular atrial fibrillation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* persistent AF (electrical cardioversion is planned)\n* written informed consent\n\nExclusion Criteria:\n\n* acute clinical signs of venous thromboembolism\n* current oral anticoagulation\n* indication for medical cardioversion'}, 'identificationModule': {'nctId': 'NCT00171769', 'briefTitle': 'Atrial Fibrillation Feasibility Certoparin Trial - AFFECT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open Label, Multi-center Trial to Evaluate the Feasibility and Safety of Short-term Treatment With Subcutaneously Injected Certoparin (8000 U Anti-Xa Twice Daily) in Patients With Persistent Nonvalvular Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'CMEX839BDE01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Certoparin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}, {'city': 'Investigative Centers', 'country': 'Germany'}], 'overallOfficials': [{'name': 'novartis pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}