Patients Undergoing Diagnostic Coronary AngiographyRAPID-1NCT04301921
Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Diagnostic Transradial Coronary Angiography Without Systemic Anticoagulatio
A study testing Traditional punkcture site and No anticoagulation and Traditional punkcture site and ACT-guided anticoagulation in people with Patients Undergoing Diagnostic Coronary Angiography, run by Prof. Dr. med. Ingo Eitel.
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
- Patients Undergoing Diagnostic Coronary Angiography
- What is being tested?
- Traditional punkcture site and No anticoagulation and Traditional punkcture site and ACT-guided anticoagulation
- 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 30 Jun 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
- Age > 18 years
- Written informed consent
Who cannot join
- 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
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
- Traditional punkcture site and No anticoagulation, Traditional punkcture site and ACT-guided anticoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional punkcture site and No anticoagulationOther
Traditional punkcture site and No anticoagulation
Traditional punkcture site and ACT-guided anticoagulationOther
Traditional punkcture site and ACT-guided anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Traditional puncture site + no anticoagulation Receives: Other: Traditional punkcture site and No anticoagulation |
| Group 2 | Other | Traditional puncture site + ACT-guided anticoagulation Receives: Other: Traditional punkcture site and ACT-guided anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Bleeding events
Will be bleeding events according to Bleeding Academic Research Consortium (BARC) criteria.
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 posted10 Mar 2020
- Study start1 May 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Jun 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 Patients 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
- Prof. Dr. med. Ingo Eitel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Ingo Eitel, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301921
- Sponsor's protocol ID
- RAPID-1
- Acronym
- RAPID-1
- Status last verified
- Apr 2020
- First submitted
- 18 Feb 2020
- Last updated
- 24 Apr 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 24 Apr 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 - Diagnostic Transradial Coronary Angiography Without Systemic Anticoagulatio
- ClinicalTrials.gov ID
- NCT04301921
- Acronym / sponsor ID
- RAPID-1 / RAPID-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Ingo EitelUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 10 Mar 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 | Other | Other: Traditional punkcture site and No anticoagulationTraditional puncture site + no anticoagulation |
| Group 2 | Other | Other: Traditional punkcture site and ACT-guided anticoagulationTraditional puncture site + ACT-guided anticoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical indication to perform diagnostic coronary angiography
- Age > 18 years
- Written informed consent
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Traditional punkcture site and No anticoagulationTraditional punkcture site and No anticoagulation | Other | Group 1 |
| Traditional punkcture site and ACT-guided anticoagulationTraditional punkcture site and ACT-guided anticoagulation | Other | Group 2 |
Primary outcome
Occurrence of postprocedural RAO
Time frame: Day 1
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.
Bleeding events
Time frame: Day 1
Will be bleeding events according to Bleeding Academic Research Consortium (BARC) criteria.
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 24 Apr 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 Traditional punkcture site and No anticoagulation and Traditional punkcture site and ACT-guided anticoagulation in people with Patients Undergoing Diagnostic Coronary Angiography, run by Prof. Dr. med. Ingo Eitel.
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 3 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 24 Apr 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 RAO (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT04301921, 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 24 Apr 2020.