Clinical trial NCT01402427: Is Verapamil In TransRadial Interventions OmittabLe?
Official title: Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Verapamil Toxicity
Keywords: Coronary Artery Disease
Coronary Angiography
Percutaneous Coronary Intervention
Transradial
Radial Artery Spasm
Verapamil
Adverse Effects
Lead sponsor: State Health Center, Hungary
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 591
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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

Primary outcomes:
measure: Rate of Access Site Conversions
timeFrame: Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.
Secondary outcomes:
measure: Rate of Code Breaks
timeFrame: Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.
measure: Rate of Vasodilator Use
timeFrame: Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.
measure: Procedural Time
timeFrame: Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.
measure: Fluoroscopic Time
timeFrame: Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.
measure: Contrast Volume
timeFrame: The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.
measure: Subjective Pain
timeFrame: Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: State Health Center
Study officials:
affiliation: State Health Center, Budapest, Hungary
name: Istvan Hizoh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Health Center, Budapest, Hungary
name: Robert Gabor Kiss, MD, PhD
role: STUDY_CHAIR
References:
citation: Hizoh I, Majoros Z, Major L, Gulyas Z, Szabo G, Kerecsen G, Korda A, Molnar F, Kiss RG. Need for prophylactic application of verapamil in transradial coronary procedures: a randomized trial. The VITRIOL (is Verapamil In TransRadial Interventions OmittabLe?) trial. J Am Heart Assoc. 2014 Apr 14;3(2):e000588. doi: 10.1161/JAHA.113.000588.