Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT04362020
Status:
UNKNOWN
Last Update Posted:
2020-05-12
First Post:
2020-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Subgroup of Patients on Oral Anticoagulants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-08', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-04-22', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of postprocedural radial artery occlusion', 'timeFrame': 'Day 1', 'description': 'Will be the occurrence of postprocedural radial artery occlusion assessed with high-resolution vascular ultrasound. Experienced sonographers will perform color Doppler ultrasound in all study patients after removal of the compression device to examine the radial, ulnar, and brachial arteries of the access forearm.'}], 'secondaryOutcomes': [{'measure': 'Sonographic characteristics of radial artery occlusion', 'timeFrame': '3 Month', 'description': 'Occlusion lengths or minimal residual perfusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Undergoing Diagnostic Coronary Angiography']}, 'referencesModule': {'references': [{'pmid': '40191883', 'type': 'DERIVED', 'citation': 'Stiermaier T, Grunewalder M, Patz T, Rawish E, Joost A, Meusel M, Marquetand C, Kurz T, Schmidt T, Frerker C, Fuernau G, Eitel I. Distal access and procedural anticoagulation to prevent radial artery occlusion after coronary angiography - the randomised RAPID trial. EuroIntervention. 2025 Apr 7;21(7):e366-e375. doi: 10.4244/EIJ-D-24-00846.'}]}, 'descriptionModule': {'briefSummary': 'To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical indication to perform diagnostic coronary angiography\n* Pretreatment with oral anticoagulants (phenprocoumon or direct oral anticoagulants \\[dabigatran, apixaban, rivaroxaban, or edoxaban\\])\n* Age \\> 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Already administered additional anticoagulation prior to coronary angiography\n* Planned coronary intervention\n* Preexisting radial artery occlusion or missing pulse at the potential puncture sites\n* Allergy / intolerance to anticoagulants\n* Active bleeding or comorbidity with elevated bleeding risk\n* Pregnancy\n* Inability to sign informed consent\n* Participation in another trial'}, 'identificationModule': {'nctId': 'NCT04362020', 'acronym': 'RAPID-2', 'briefTitle': 'Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Subgroup of Patients on Oral Anticoagulants', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Subgroup of Patients on Oral Anticoagulants', 'orgStudyIdInfo': {'id': 'RAPID-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group-1', 'description': 'No anticoagulation', 'interventionNames': ['Other: Distal radial access']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group-2', 'description': 'ACT-guided anticoagulation', 'interventionNames': ['Other: Distal radial access']}], 'interventions': [{'name': 'Distal radial access', 'type': 'OTHER', 'description': 'Distal radial access and No anticoagulation', 'armGroupLabels': ['Group-1']}, {'name': 'Distal radial access', 'type': 'OTHER', 'description': 'Distal radial access and ACT-guided anticoagulation', 'armGroupLabels': ['Group-2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Prof. Dr. med. Ingo Eitel', 'investigatorAffiliation': 'University of Luebeck'}}}}