Is Verapamil In TransRadial Interventions OmittabLe? (VITRIOL)

April 30, 2014 updated by: Istvan Hizoh, MD, PhD, State Health Center, Hungary

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

591

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Budapest, Hungary, 1134
        • State Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Intraarterial administration of 10 mL saline.
Active Comparator: 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
Time Frame: Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.
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
Time Frame: Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.
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
Time Frame: Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.
Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.
Procedural Time
Time Frame: Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.
Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.
Fluoroscopic Time
Time Frame: Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.
Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.
Contrast Volume
Time Frame: The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.
The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.
Subjective Pain
Time Frame: Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.
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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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