Is Verapamil In TransRadial Interventions OmittabLe?

Not Applicable

Completed

• Conditions: Coronary Disease; Verapamil Toxicity
• Interventions: Drug: Verapamil; Drug: Placebo

• Registration Number: NCT01402427
• Lead Sponsor: State Health Center, Hungary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2014-04
• Results First Submitted: 2014-04-17
• Results First Submitted QC: 2014-04-30
• Last Update Submitted: 2014-04-30
• Results First Posted: 2014-06-02
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 591

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verapamil	Verapamil	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Rate of Access Site Conversions	Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.

Secondary Outcome Measures

Name	Time	Method
Rate of Code Breaks	Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.	Code break: a composite of access site conversion and unplanned use of vasodilators.
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.
Subjective Pain	Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.	Analysis of the rates of significant pain defined as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.

Trial Locations

Locations (1)

State Health Center; 🇭🇺 Budapest, Hungary