Is Verapamil In TransRadial Interventions OmittabLe?

Coronary Disease Clinical Trial

— VITRIOL  

Official title:

Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402427
• Other study ID #: SHCCARD-001
• Status: Completed
• Phase: N/A
• First received: July 21, 2011
• Last updated: April 30, 2014
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: April 2014
• Source: State Health Center, Hungary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Institutional Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Verapamil Toxicity

Intervention

Drug:
• Verapamil
Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
• Placebo
Intraarterial administration of 10 mL saline.

Locations

Country	Name	City	State
Hungary	State Health Center	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
State Health Center, Hungary

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

Hizoh I, Majoros Z, Major L, Gulyas Z, Szabo G, Kerecsen G, Korda A, Molnar F, Kiss RG. Need for prophylactic application of verapamil in transradial coronary procedures: a randomized trial. The VITRIOL (is Verapamil In TransRadial Interventions OmittabLe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Access Site Conversions		Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.	Yes
Secondary	Rate of Code Breaks	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.	Yes
Secondary	Rate of Vasodilator Use		Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.	Yes
Secondary	Procedural Time		Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.	Yes
Secondary	Fluoroscopic Time		Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.	Yes
Secondary	Contrast Volume		The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.	Yes
Secondary	Subjective Pain	Analysis of the rates of signi?cant pain de?ned 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.	Yes