Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Subgroup of Patients on Oral Anticoagulants

Not Applicable

• Conditions: Patient Undergoing Diagnostic Coronary Angiography
• Interventions: Other: Distal radial access

• Registration Number: NCT04362020
• Lead Sponsor: University of Luebeck

Brief Summary

To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Status Verified: 2020-05
• Study Start: 2020-05-01
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-12
• Primary Completion: 2021-11-30
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Clinical indication to perform diagnostic coronary angiography
• Pretreatment with oral anticoagulants (phenprocoumon or direct oral anticoagulants [dabigatran, apixaban, rivaroxaban, or edoxaban])
• Age > 18 years
• Written informed consent

Exclusion Criteria

• Already administered additional anticoagulation prior to coronary angiography
• Planned coronary intervention
• Preexisting radial artery occlusion or missing pulse at the potential puncture sites
• Allergy / intolerance to anticoagulants
• Active bleeding or comorbidity with elevated bleeding risk
• Pregnancy
• Inability to sign informed consent
• Participation in another trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-1	Distal radial access	No anticoagulation
Group-2	Distal radial access	ACT-guided anticoagulation

Primary Outcome Measures

Name	Time	Method
Occurrence of postprocedural radial artery occlusion	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Sonographic characteristics of radial artery occlusion	3 Month	Occlusion lengths or minimal residual perfusion