Radial Artery SpasmPhase 4NCT06447688
The Role of Verapamil in Radial Artery Spasm
A Phase 4 study testing Verapamil in people with Radial Artery Spasm, run by Mersin Medicalpark Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
Coronary angiography (CAG) is an invasive imaging method performed to determine the degree of coronary artery disease. Radial artery spasm (RAS) is one of the most common complications during coronary angiography performed via the transradial approach, causing patient discomfort or sometimes interrupting the… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Radial Artery Spasm
- What is being tested?
- Verapamil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2024to 15 Nov 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo daily coronary angiography
- Whose Allen test is normal.
- Must be able to swallow tablets
Who cannot join
- Allen test results are distorted,
- No pulse in the radial artery,
- Patients who have previously undergone radial angiography and whose hemodynamics are compromised will be excluded from the study.
- Patients with known contraindications to verapamil (significant aortic stenosis, heart rate <50/min, high-grade atrioventricular block, myocardial infarction) complicated with cardiogenic shock, or left ventricular ejection fraction <35%).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Oral Verapamil in Preventing Radial Spasm During Transradial Angiography
Coronary angiography (CAG) is an invasive imaging method performed to determine the degree of coronary artery disease. Radial artery spasm (RAS) is one of the most common complications during coronary angiography performed via the transradial approach, causing patient discomfort or sometimes interrupting the procedure. There are many studies on RAS, and various pharmacoagents administered intravenously (intraarterial) to prevent RAS have been described. However, there is limited data in the literature regarding oral pharmacoagents that will prevent this complication. In our study, the preventive effect of Verapamil, given orally 2 hours before coronary angiography, on radial artery spasm will be investigated.
Read the detailed description
Transradial access (TRA) has emerged as the preferred modality for vascular access in coronary interventions worldwide, prompting growing interest in its potential applications across other interventional specialties, especially in neurovascular procedures. Radial artery spasm (RAS) remains the most common complication of TRA, often causing procedural difficulties, patient discomfort, and an increased risk of access site crossover. The incidence of radial artery spasm reported in the literature varies widely, with estimates ranging from 4% to over 51.3%, influenced by factors such as definitions, patient selection, and the operator's experience.
After puncturing the radial artery (Puncture-induced RAS) and inserting the sheath-but before administering intra-arterial spasmolytics-local discomfort and pain may trigger a sympathetic vasoconstrictive response, potentially leading to the onset of RAS.
A previous study has stated that preventing RAS is more effective than treating it after it has been established. In this context, we will conduct a randomized controlled trial to evaluate the efficacy of 120 mg of oral verapamil administered two hours before radial artery puncture in reducing the incidence of radial artery spasm (RAS)
- Conditions
- Radial Artery Spasm
- Being tested
- Verapamil
- Keywords
- radial artery spasm, verapamil, transradial access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerapamilDrug
Prevent
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | No other vasodilating drug such as nitrate will be given intravenously Receives: Drug: Verapamil |
| Verapamil | Active comparator | Verapamil will be given orally at least 2 hours before angiography Receives: Drug: Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Radial Artery Spasm (RAS)
Clinical RAS defined as presence of at least 2 of the following: (1) forearm pain ≥ 4/10, (2) pain during catheter manipulation, (3) catheter movement restriction, (4) pain during sheath removal, (5) difficulty in sheath removal.
Measured: During the coronary angiography procedure (up to 2 hours from sheath insertion)
Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS)
Radial artery spasm (RAS) was defined as luminal narrowing of ≥50% as measured by ultrasonography at the access site.
Measured: During the procedure, immediately after catheterization (within 2 hours)
Secondary outcomes (4)
Number of Participants With Procedural Success
Procedure success was defined as completing coronary angiography or PCI using the initial radial artery approach without requiring a switch to an alternative access site.
Measured: During the procedure (from sheath insertion to procedure completion)
Mean Volume of Contrast Media Used (mL) (mL)
The volume of contrast media (in ml) used was recorded
Measured: During the procedure (from sheath insertion to procedure completion)
Mean of the Dose Area Product (DAP)
The parameters collected for radiation exposure included the DAP
Measured: During the procedure (from sheath insertion to procedure completion)
Mean of the Fluoroscopy Time
The parameters collected for radiation exposure included the fluoroscopy time (in minutes)
Measured: During the procedure (from sheath insertion to procedure completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start5 Jun 2024
- Primary completion1 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radial Artery SpasmStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin Medicalpark Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sefa Sural, Mersin Medicalpark Hastanesi
- Investigators
- Sefa Sural, MD, Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447688
- Sponsor's protocol ID
- MLP-SSURAL-001
- Status last verified
- Sep 2025
- First submitted
- 31 May 2024
- Last updated
- 10 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sural S, Dogen ME, Duzel B, Karaca O, Brilakis ES, Gorgulu S. The Role of Oral Verapamil in Preventing Radial Spasm During Transradial Angiography. Catheter Cardiovasc Interv. 2025 Aug;106(2):1247-1254. doi: 10.1002/ccd.31675. Epub 2025 Jun 8.
PubMed 40485154
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Oral Verapamil in Preventing Radial Spasm During Transradial Angiography
- ClinicalTrials.gov ID
- NCT06447688
- Acronym / sponsor ID
- MLP-SSURAL-001
- Conditions
- Radial Artery Spasm
- Keywords
- radial artery spasm, verapamil, transradial access
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mersin Medicalpark HastanesiUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Posted 10 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary angiography (CAG) is an invasive imaging method performed to determine the degree of coronary artery disease. Radial artery spasm (RAS) is one of the most common complications during coronary angiography performed via the transradial approach, causing patient discomfort or sometimes interrupting the procedure. There are many studies on RAS, and various pharmacoagents administered intravenously (intraarterial) to prevent RAS have been described. However, there is limited data in the literature regarding oral pharmacoagents that will prevent this complication. In our study, the preventive effect of Verapamil, given orally 2 hours before coronary angiography, on radial artery spasm will be investigated.
Detailed description
Transradial access (TRA) has emerged as the preferred modality for vascular access in coronary interventions worldwide, prompting growing interest in its potential applications across other interventional specialties, especially in neurovascular procedures. Radial artery spasm (RAS) remains the most common complication of TRA, often causing procedural difficulties, patient discomfort, and an increased risk of access site crossover. The incidence of radial artery spasm reported in the literature varies widely, with estimates ranging from 4% to over 51.3%, influenced by factors such as definitions, patient selection, and the operator's experience.
After puncturing the radial artery (Puncture-induced RAS) and inserting the sheath-but before administering intra-arterial spasmolytics-local discomfort and pain may trigger a sympathetic vasoconstrictive response, potentially leading to the onset of RAS.
A previous study has stated that preventing RAS is more effective than treating it after it has been established. In this context, we will conduct a randomized controlled trial to evaluate the efficacy of 120 mg of oral verapamil administered two hours before radial artery puncture in reducing the incidence of radial artery spasm (RAS)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: VerapamilNo other vasodilating drug such as nitrate will be given intravenously |
| Verapamil | Active comparator | Drug: VerapamilVerapamil will be given orally at least 2 hours before angiography |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who undergo daily coronary angiography
- Whose Allen test is normal.
- Must be able to swallow tablets
Key exclusion criteria (4 listed)
- Allen test results are distorted,
- No pulse in the radial artery,
- Patients who have previously undergone radial angiography and whose hemodynamics are compromised will be excluded from the study.
- Patients with known contraindications to verapamil (significant aortic stenosis, heart rate <50/min, high-grade atrioventricular block, myocardial infarction) complicated with cardiogenic shock, or left ventricular ejection fraction <35%).
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 |
|---|---|---|
| VerapamilPrevent | Drug | Placebo, Verapamil |
Primary outcome
Number of Participants With Clinical Radial Artery Spasm (RAS)
Time frame: During the coronary angiography procedure (up to 2 hours from sheath insertion)
Clinical RAS defined as presence of at least 2 of the following: (1) forearm pain ≥ 4/10, (2) pain during catheter manipulation, (3) catheter movement restriction, (4) pain during sheath removal, (5) difficulty in sheath removal.
Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS)
Time frame: During the procedure, immediately after catheterization (within 2 hours)
Radial artery spasm (RAS) was defined as luminal narrowing of ≥50% as measured by ultrasonography at the access site.
4 secondary outcomes
Number of Participants With Procedural Success
Time frame: During the procedure (from sheath insertion to procedure completion)
Mean Volume of Contrast Media Used (mL) (mL)
Time frame: During the procedure (from sheath insertion to procedure completion)
Mean of the Dose Area Product (DAP)
Time frame: During the procedure (from sheath insertion to procedure completion)
Mean of the Fluoroscopy Time
Time frame: During the procedure (from sheath insertion to procedure completion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40485154Sural S, Dogen ME, Duzel B, Karaca O, Brilakis ES, Gorgulu S. The Role of Oral Verapamil in Preventing Radial Spasm During Transradial Angiography. Catheter Cardiovasc Interv. 2025 Aug;106(2):1247-1254. doi: 10.1002/ccd.31675. Epub 2025 Jun 8.
- Journal publication of study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sefa Sural, MD principal investigator
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Verapamil in people with Radial Artery Spasm, run by Mersin Medicalpark Hastanesi at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Clinical Radial Artery Spasm (RAS) (time frame: During the coronary angiography procedure (up to 2 hours from sheath insertion)). 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 NCT06447688, 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 10 Oct 2025.