NCT04301921

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

February 18, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

1.4 years

First QC Date

February 18, 2020

Last Update Submit

April 22, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Occurrence of postprocedural RAO

    Will be the occurrence of postprocedural RAO 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

  • Bleeding events

    Will be bleeding events according to Bleeding Academic Research Consortium (BARC) criteria.

    Day 1

Secondary Outcomes (1)

  • Sonographic characteristics of radial artery occlusion

    3 Month

Study Arms (2)

Group 1

OTHER

Traditional puncture site + no anticoagulation

Other: Traditional punkcture site and No anticoagulation

Group 2

OTHER

Traditional puncture site + ACT-guided anticoagulation

Other: Traditional punkcture site and ACT-guided anticoagulation

Interventions

Traditional punkcture site and No anticoagulation

Group 1

Traditional punkcture site and ACT-guided anticoagulation

Group 2

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
  • Age \> 18 years
  • Written informed consent

You may not qualify if:

  • Preexisting or already administered 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.

Study Design

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

Study Record Dates

First Submitted

February 18, 2020

First Posted

March 10, 2020

Study Start

May 1, 2020

Primary Completion

September 30, 2021

Study Completion

June 30, 2022

Last Updated

April 24, 2020

Record last verified: 2020-04