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 30, 2014
Last verified: April 2014
  Purpose

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.


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:


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 unplanned 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 ]
    Analysis of the rates of significant pain defined as pain score ≥4 on 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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
Results First Received: April 17, 2014
Last Updated: April 30, 2014
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
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on August 01, 2014