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OpenTrials
Completed

NCT Number: NCT01402427

Is Verapamil In TransRadial Interventions OmittabLe?

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.

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Key information

Conditions

Coronary Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Heart Diseases Myocardial Ischemia Vascular Diseases Verapamil Toxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State Health Center

Budapest, 1134, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verapamil

Drug

Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.

Placebo

Drug

Intraarterial administration of 10 mL saline.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Rate of Vasodilator Use

    Time frame: Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.

  3. Procedural Time

    Time frame: Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.

  4. Fluoroscopic Time

    Time frame: Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.

  5. Contrast Volume

    Time frame: The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.

  6. 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.

Sponsors and collaborators

Lead sponsor

State Health Center, Hungary

Other

Registry information

Official study title

Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions

Acronym: VITRIOL

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 26, 2011
Registry last updated
Jun 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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