Is Verapamil In TransRadial Interventions OmittabLe? (VITRIOL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Istvan Hizoh, MD, PhD, State Health Center, Hungary
ClinicalTrials.gov Identifier:
NCT01402427
First received: July 21, 2011
Last updated: April 15, 2013
Last verified: April 2013

July 21, 2011
April 15, 2013
March 2011
August 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01402427 on ClinicalTrials.gov Archive Site
  • Rate of code breaks [ Time Frame: Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention. ] [ Designated as safety issue: Yes ]
    Code break: a composite of access site conversion and extra use of vasodilators.
  • Rate of vasodilator use [ Time Frame: Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention. ] [ Designated as safety issue: Yes ]
  • Procedural time [ Time Frame: Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention. ] [ Designated as safety issue: Yes ]
  • Fluoroscopic time [ Time Frame: Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention. ] [ Designated as safety issue: Yes ]
  • Contrast volume [ Time Frame: The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention. ] [ Designated as safety issue: Yes ]
  • Subjective pain [ Time Frame: Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention. ] [ Designated as safety issue: Yes ]
    Measured using a semiquantitative scale ranging from 1 to 6.
Same as current
Not Provided
Not Provided
 
Is Verapamil In TransRadial Interventions OmittabLe?
Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions

Background. Verapamil is routinely used in transradial procedures to prevent the spasm of the radial artery (RAS). However, verapamil has deleterious side effects and it is contraindicated in patients with reduced left ventricular systolic function, aortic stenosis, significant bradycardia, myocardial infarction complicated by cardiogenic shock and/or high grade AV block.

Methods. To test the hypothesis, whether verapamil is omittable, a randomized, double-blind, placebo-controlled trial is conducted. Patients receive either 5 mg verapamil IA (diluted with saline, n≈300) or placebo (saline alone, n≈300). Rate of access site conversions is compared as primary safety endpoint. Rate of code breaks (composite of access site crossovers and extra use of vasodilators), frequency of vasodilator use, procedural and fluoroscopic time, contrast volume, subjective pain of the patients are analyzed as secondary endpoints. Subanalysis of code breaks determining the underlying cause (RAS or anatomical variation) is also performed and in case of RAS the efficacy of ad hoc administered verapamil is determined. Assuming a conversion rate of 2.0% in the verapamil group, the study is a priori adequately powered (>80%) to detect a 5.0% difference in crossovers.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
  • Coronary Disease
  • Verapamil Toxicity
  • Drug: Verapamil
    Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
  • Drug: Placebo
    Intraarterial administration of 10 mL saline.
  • Active Comparator: Verapamil
    Intervention: Drug: Verapamil
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
591
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT01402427
SHCCARD-001
No
Istvan Hizoh, MD, PhD, State Health Center, Hungary
State Health Center, Hungary
Not Provided
Principal Investigator: Istvan Hizoh, MD, PhD State Health Center, Budapest, Hungary
Study Chair: Robert Gabor Kiss, MD, PhD State Health Center, Budapest, Hungary
State Health Center, Hungary
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP