Trial Outcomes & Findings for The Role of Verapamil in Radial Artery Spasm (NCT NCT06447688)
NCT ID: NCT06447688
Last Updated: 2025-10-10
Results Overview
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.
COMPLETED
PHASE4
150 participants
During the coronary angiography procedure (up to 2 hours from sheath insertion)
2025-10-10
Participant Flow
All consecutive patients undergoing transradial coronary angiography between June-November 2024 at Medicalpark Hospital (Mersin, Turkey) were included. Exclusion criteria were abnormal Allen test, absent radial pulse, prior radial access, hemodynamic instability, or contraindications to verapamil (e.g., severe AS, HR \<50, high-grade AV block, cardiogenic shock, EF \<35%).
No pre-assignment washout or run-in period was required. All eligible participants were randomized immediately after enrollment.
Participant milestones
| Measure |
Placebo
Participants did not receive any prophylactic medication to prevent radial artery spasm and underwent standard transradial coronary angiography.
|
Verapamil
Participants in this arm received a single oral dose of verapamil (120 mg) prior to the transradial coronary angiography procedure as prophylaxis against radial artery spasm.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=75 Participants
Participants did not receive any prophylactic medication to prevent radial artery spasm and underwent standard transradial coronary angiography.
|
Verapamil
n=75 Participants
Participants received a single oral dose of verapamil (120 mg) approximately 2 hours before transradial coronary angiography as prophylaxis against radial artery spasm.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 12.1 • n=75 Participants
|
59.4 years
STANDARD_DEVIATION 11.1 • n=75 Participants
|
58.8 years
STANDARD_DEVIATION 11.6 • n=150 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=75 Participants
|
26 Participants
n=75 Participants
|
49 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=75 Participants
|
49 Participants
n=75 Participants
|
101 Participants
n=150 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
75 Participants
n=75 Participants
|
75 Participants
n=75 Participants
|
150 Participants
n=150 Participants
|
PRIMARY outcome
Timeframe: During the coronary angiography procedure (up to 2 hours from sheath insertion)Population: All randomized participants were included in the analysis
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.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants did not receive any prophylactic medication to prevent radial artery spasm and underwent standard transradial coronary angiography
|
Verapamil
n=75 Participants
Participants received a single oral dose of verapamil (120 mg) approximately 2 hours before transradial coronary angiography as prophylaxis against radial artery spasm
|
|---|---|---|
|
Number of Participants With Clinical Radial Artery Spasm (RAS)
|
23 participants
|
3 participants
|
PRIMARY outcome
Timeframe: During the procedure, immediately after catheterization (within 2 hours)Population: All randomized participants were included in the analysis (75 in the placebo group and 75 in the oral verapamil group)
Radial artery spasm (RAS) was defined as luminal narrowing of ≥50% as measured by ultrasonography at the access site.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants did not receive any prophylactic medication to prevent radial artery spasm and underwent standard transradial coronary angiography
|
Verapamil
n=75 Participants
Participants received a single oral dose of verapamil (120 mg) approximately 2 hours before transradial coronary angiography as prophylaxis against radial artery spasm
|
|---|---|---|
|
Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS)
|
36 participants
|
8 participants
|
SECONDARY outcome
Timeframe: During the procedure (from sheath insertion to procedure completion)Population: All randomized participants were included in the analysis
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.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants did not receive any prophylactic medication to prevent radial artery spasm and underwent standard transradial coronary angiography
|
Verapamil
n=75 Participants
Participants received a single oral dose of verapamil (120 mg) approximately 2 hours before transradial coronary angiography as prophylaxis against radial artery spasm
|
|---|---|---|
|
Number of Participants With Procedural Success
|
75 participants
|
75 participants
|
SECONDARY outcome
Timeframe: During the procedure (from sheath insertion to procedure completion)Population: All randomized participants were included in the analysis
The volume of contrast media (in ml) used was recorded
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants did not receive any prophylactic medication to prevent radial artery spasm and underwent standard transradial coronary angiography
|
Verapamil
n=75 Participants
Participants received a single oral dose of verapamil (120 mg) approximately 2 hours before transradial coronary angiography as prophylaxis against radial artery spasm
|
|---|---|---|
|
Mean Volume of Contrast Media Used (mL) (mL)
|
133.8 Milliliters (mL)
Standard Deviation 71.9
|
136.4 Milliliters (mL)
Standard Deviation 78.3
|
SECONDARY outcome
Timeframe: During the procedure (from sheath insertion to procedure completion)Population: All randomized participants were included in the analysis
The parameters collected for radiation exposure included the DAP
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants did not receive any prophylactic medication to prevent radial artery spasm and underwent standard transradial coronary angiography
|
Verapamil
n=75 Participants
Participants received a single oral dose of verapamil (120 mg) approximately 2 hours before transradial coronary angiography as prophylaxis against radial artery spasm
|
|---|---|---|
|
Mean of the Dose Area Product (DAP)
|
873.9 Gy·cm2
Standard Deviation 732.3
|
878.8 Gy·cm2
Standard Deviation 736.7
|
SECONDARY outcome
Timeframe: During the procedure (from sheath insertion to procedure completion)Population: All randomized participants were included in the analysis
The parameters collected for radiation exposure included the fluoroscopy time (in minutes)
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants did not receive any prophylactic medication to prevent radial artery spasm and underwent standard transradial coronary angiography
|
Verapamil
n=75 Participants
Participants received a single oral dose of verapamil (120 mg) approximately 2 hours before transradial coronary angiography as prophylaxis against radial artery spasm
|
|---|---|---|
|
Mean of the Fluoroscopy Time
|
7.9 minute
Standard Deviation 7.3
|
6.9 minute
Standard Deviation 5.8
|
Adverse Events
Placebo
Verapamil
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place