CClinicalTrials.gg
Status unknownNCT04362020RAPID-2Updated May 12, 2020

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

An interventional study of Distal radial access and Distal radial access in Patient Undergoing Diagnostic Coronary Angiography, sponsored by University of Luebeck. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-12.

Sponsored by University of Luebeck · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Patient Undergoing Diagnostic Coronary Angiography
03

In context

Lead sponsor

University of Luebeck is the lead sponsor of 74 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Group-1

    No anticoagulation

    Other: Distal radial access

  • Active comparator
    Group-2

    ACT-guided anticoagulation

    Other: Distal radial access

Interventions

  • OtherDistal radial access

    Distal radial access and No anticoagulation

  • OtherDistal radial access

    Distal radial access and ACT-guided anticoagulation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

Secondary outcomes

  1. Sonographic characteristics of radial artery occlusion

    Occlusion lengths or minimal residual perfusion

    Time frame: 3 Month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04362020
Lead sponsor
University of Luebeck
Responsible party
Prof. Dr. med. Ingo Eitel (Director, University of Luebeck) — Principal investigator
First posted
Apr 24, 2020
Start date
May 1, 2020 (estimated)
Primary completion
Nov 30, 2021 (estimated)
Completion
Aug 31, 2022 (estimated)
Last update
May 12, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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