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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
History of Changes
  Purpose

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.


Condition Intervention
Coronary Disease
Verapamil Toxicity
 Drug: Verapamil
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by State Health Center, Hungary:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 591
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Verapamil Drug: Verapamil
Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
Placebo Comparator: Placebo Drug: Placebo
Intraarterial administration of 10 mL saline.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402427

Locations
Hungary
State Health Center
Budapest, Hungary, 1134
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Istvan Hizoh, MD, PhD, Senior Consultant, State Health Center, Hungary
ClinicalTrials.gov Identifier: NCT01402427     History of Changes
Other Study ID Numbers: SHCCARD-001
Study First Received: July 21, 2011
Last Updated: April 15, 2013
Health Authority: Hungary: Institutional Ethics Committee

Keywords provided by State Health Center, Hungary:
Coronary Artery Disease
Coronary Angiography
Percutaneous Coronary Intervention
Transradial
 Radial Artery Spasm
Verapamil
Adverse Effects

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Verapamil
Diltiazem
 Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 22, 2013