The Role of Verapamil in Radial Artery Spasm

NCT06447688 | Completed Phase 4 Results

• 1 other identifier: MLP-SSURAL-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Radial Artery Spasm

Keywords

radial artery spasm, verapamil, transradial access

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  During the procedure, immediately after catheterization (within 2 hours)

Secondary Outcomes (4)

• Number of Participants With Procedural Success

  During the procedure (from sheath insertion to procedure completion)

• Mean Volume of Contrast Media Used (mL) (mL)

  During the procedure (from sheath insertion to procedure completion)

• Mean of the Dose Area Product (DAP)

  During the procedure (from sheath insertion to procedure completion)

• Mean of the Fluoroscopy Time

  During the procedure (from sheath insertion to procedure completion)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

No other vasodilating drug such as nitrate will be given intravenously

Drug: Verapamil

Verapamil

ACTIVE COMPARATOR

Verapamil will be given orally at least 2 hours before angiography

Drug: Verapamil

Interventions

Verapamil DRUG

Prevent

Placebo; Verapamil

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who undergo daily coronary angiography
• Whose Allen test is normal.
• Must be able to swallow tablets

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Mersin Medicalpark Hastanesi: lead

Study Sites (1)

VM Medicalpark

Mersin, 33010, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40485154 RESULT

Related Links

• Journal publication of study results

MeSH Terms

Interventions

Verapamil

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Sefa SURAL
• Organization: Medicalpark Hospital

sesural@hotmail.com

+90 532 565 0160

Study Officials

• Sefa Sural, MD

  Istinye University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MEDICAL DOKTOR( Principal investigator)

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 7, 2024
• Study Start: June 5, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 15, 2024
• Last Updated: October 10, 2025
• Results First Posted: October 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)