MedTrace Logo

Is Verapamil In TransRadial Interventions OmittabLe?

NCT01402427 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 591

Last updated 2014-06-02

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Verapamil

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

DRUG

Placebo

Intraarterial administration of 10 mL saline.

Sponsors & Collaborators

  • State Health Center, Hungary

    lead OTHER

Principal Investigators

  • Istvan Hizoh, MD, PhD · State Health Center, Budapest, Hungary

  • Robert Gabor Kiss, MD, PhD · State Health Center, Budapest, Hungary

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01402427 on ClinicalTrials.gov