Is Verapamil In TransRadial Interventions OmittabLe?
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
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.