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

Patient Undergoing Diagnostic Coronary Angiography Clinical Trial

— RAPID-2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04362020
• Other study ID #: RAPID-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2020
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: August 31, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Undergoing Diagnostic Coronary Angiography

Intervention

Other:
• Distal radial access
Distal radial access and No anticoagulation
• Distal radial access
Distal radial access and ACT-guided anticoagulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of postprocedural radial artery occlusion	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.	Day 1
Secondary	Sonographic characteristics of radial artery occlusion	Occlusion lengths or minimal residual perfusion	3 Month