NCT04362020

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

1.6 years

First QC Date

April 22, 2020

Last Update Submit

May 8, 2020

Conditions

Patient Undergoing Diagnostic Coronary Angiography

Outcome Measures

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.

    Day 1

Secondary Outcomes (1)

  • Sonographic characteristics of radial artery occlusion

    3 Month

Study Arms (2)

Group-1

EXPERIMENTAL

No anticoagulation

Other: Distal radial access

Group-2

ACTIVE COMPARATOR

ACT-guided anticoagulation

Other: Distal radial access

Interventions

Distal radial accessOTHER

Distal radial access and No anticoagulation

Group-1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 40191883DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

May 1, 2020

Primary Completion

November 30, 2021

Study Completion

August 31, 2022

Last Updated

May 12, 2020

Record last verified: 2020-05