Is Verapamil In TransRadial Interventions OmittabLe?

NCT01402427 | Completed Results

• 1 other identifier: SHCCARD-001
• Study Type: interventional
• Target: 591
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Disease; Verapamil Toxicity

Keywords

Coronary Artery Disease; Coronary Angiography; Percutaneous Coronary Intervention; Transradial; Radial Artery Spasm; Verapamil; Adverse Effects

Outcome Measures

Primary Outcomes (1)

• Rate of Access Site Conversions

  Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.

Secondary Outcomes (6)

• Rate of Code Breaks

  Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.

• Rate of Vasodilator Use

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

• Procedural Time

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

• Fluoroscopic Time

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

• Contrast Volume

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

Study Arms (2)

Verapamil

ACTIVE COMPARATOR

Drug: Verapamil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Verapamil DRUG

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

Verapamil

Placebo DRUG

Intraarterial administration of 10 mL saline.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing transradial coronary angiography and/or percutaneous coronary intervention
• successful cannulation of the radial artery

You may not qualify if:

• 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

Sponsors & Collaborators

• State Health Center, Hungary: lead

Study Sites (1)

State Health Center

Budapest, 1134, Hungary

Location

Related 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?) trial. J Am Heart Assoc. 2014 Apr 14;3(2):e000588. doi: 10.1161/JAHA.113.000588.

  PMID: 24732918 RESULT

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Interventions

Verapamil

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

The trial was conducted in a single, high-volume institution by experienced operators. The results may not be applicable to lower-volume centers or to operators with less experience.

Results Point of Contact

• Title: Istvan Hizoh, MD, PhD / Senior Consultant
• Organization: State Health Center, Hungary

ihizoh@web.de

+36 1 4651800

Study Officials

• Istvan Hizoh, MD, PhD

  State Health Center, Budapest, Hungary

  PRINCIPAL INVESTIGATOR

• Robert Gabor Kiss, MD, PhD

  State Health Center, Budapest, Hungary

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 26, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 2, 2014
• Results First Posted: June 2, 2014

Record last verified: 2014-04

Locations

HU (1)