Is Verapamil In TransRadial Interventions OmittabLe? (VITRIOL)

Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Verapamil Toxicity
• Intervention / Treatment: Drug: Verapamil; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 591
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1134
    • State Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Intraarterial administration of 10 mL saline.
Active Comparator: Verapamil	Drug: Verapamil; Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Access Site Conversions	Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Code Breaks	Code break: a composite of access site conversion and unplanned use of vasodilators.	Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.
Rate of Vasodilator Use		Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.
Procedural Time		Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.
Fluoroscopic Time		Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.
Contrast Volume		The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.
Subjective Pain	Analysis of the rates of significant pain defined as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.	Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.

Collaborators and Investigators

• Sponsor: State Health Center, Hungary
• Investigators: Principal Investigator: Istvan Hizoh, MD, PhD, State Health Center, Budapest, Hungary; Study Chair: Robert Gabor Kiss, MD, PhD, State Health Center, Budapest, Hungary

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: July 21, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (Estimate): July 26, 2011

Study Record Updates

• Last Update Posted (Estimate): June 2, 2014
• Last Update Submitted That Met QC Criteria: April 30, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Coronary Angiography; Verapamil; Adverse Effects; Transradial; Radial Artery Spasm
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Verapamil
• Other Study ID Numbers: SHCCARD-001