Patient Undergoing Diagnostic Coronary AngiographyRAPID-2NCT04362020
Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Subgroup of Patients on Oral Anticoagulants
A study testing Distal radial access in people with Patient Undergoing Diagnostic Coronary Angiography, run by University of Luebeck.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Undergoing Diagnostic Coronary Angiography
- What is being tested?
- Distal radial access
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion
- Being tested
- Distal radial access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal radial accessOther
Distal radial access and No anticoagulation
Distal radial accessOther
Distal radial access and ACT-guided anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| Group-1 | Experimental | No anticoagulation Receives: Other: Distal radial access |
| Group-2 | Active comparator | ACT-guided anticoagulation Receives: Other: Distal radial access |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
Sonographic characteristics of radial artery occlusion
Occlusion lengths or minimal residual perfusion
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Undergoing Diagnostic Coronary AngiographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Ingo Eitel, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362020
- Sponsor's protocol ID
- RAPID-2
- Acronym
- RAPID-2
- Status last verified
- May 2020
- First submitted
- 22 Apr 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40191883
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Subgroup of Patients on Oral Anticoagulants
- ClinicalTrials.gov ID
- NCT04362020
- Acronym / sponsor ID
- RAPID-2 / RAPID-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-1 | Experimental | Other: Distal radial accessNo anticoagulation |
| Group-2 | Active comparator | Other: Distal radial accessACT-guided anticoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal radial accessDistal radial access and No anticoagulation | Other | Group-1 |
| Distal radial accessDistal radial access and ACT-guided anticoagulation | Other | Group-2 |
Primary outcome
Occurrence of postprocedural radial artery occlusion
Time frame: 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.
1 secondary outcome
Sonographic characteristics of radial artery occlusion
Time frame: 3 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 40191883Stiermaier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Distal radial access in people with Patient Undergoing Diagnostic Coronary Angiography, run by University of Luebeck.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of postprocedural radial artery occlusion (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.