N/A N=591 Randomized Double-blind

Is Verapamil In TransRadial Interventions OmittabLe?

Coronary Disease · Verapamil Toxicity

Bottom Line

View on ClinicalTrials.gov: NCT01402427 ↗

Enrolled (actual)

591

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Rate of Access Site Conversions — 2; 5 participants — p=0.28

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Verapamil (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: State Health Center, Hungary
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Access Site Conversions	2; 5	0.28
SECONDARY Rate of Code Breaks	4; 10	0.11
SECONDARY Rate of Vasodilator Use	297; 6	<0.0001 sig
SECONDARY Procedural Time	17.0; 16.0	0.37
SECONDARY Fluoroscopic Time	4.8; 4.4	0.28
SECONDARY Contrast Volume	75.0; 72.5	0.74
SECONDARY Subjective Pain	26; 21	0.45

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.

Eligibility Criteria

Inclusion Criteria

patients undergoing transradial coronary angiography and/or percutaneous coronary intervention
successful cannulation of the radial artery

Exclusion Criteria

reduced left ventricular systolic function (LVEF<35%)
significant aortic stenosis
bradycardia (<50/min.)
myocardial infarction complicated by cardiogenic shock and/or high grade AV block

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Data sourced from ClinicalTrials.gov (NCT01402427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.