Is Verapamil In TransRadial Interventions OmittabLe?

Study Overview
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Brief Summary
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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.

Official Title
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Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions

Conditions
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Coronary Disease, Verapamil Toxicity

Intervention / Treatment
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* Drug: Verapamil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Verapamil<br> | Drug: Verapamil<br>* Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Intraarterial administration of 10 mL saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | Analysis of the rates of signiﬁcant pain deﬁned 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Coronary Angiography, Percutaneous Coronary Intervention, Transradial, Radial Artery Spasm, Verapamil, Adverse Effects