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Is Verapamil In TransRadial Interventions OmittabLe? — VITRIOL  

Coronary Disease Clinical Trial

Official title:
Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01402427
Study type Interventional
Source State Health Center, Hungary
Contact
Status Completed
Phase N/A
Start date March 2011
Completion date August 2011
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