NCT01402427

Is Verapamil In TransRadial Interventions OmittabLe?

Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 591 (actual)
• Sponsor: State Health Center, Hungary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings. Methods: During an investigator-initiated, randomized, double-blind trial, we evaluate the need for preventive verapamil administration. After vascular access is established, patients receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary end points.

Conditions

• Coronary Disease
• Verapamil Toxicity

Interventions

Type	Name	Description
DRUG	Verapamil	Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
DRUG	Placebo	Intraarterial administration of 10 mL saline.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-07-26
• Last updated: 2014-06-02
• Results posted: 2014-06-02

Locations

1 site across 1 country: Hungary