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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verapamil | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verapamil | Drug | Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL. |
| |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Istvan Hizoh, MD, PhD | State Health Center, Budapest, Hungary | Principal Investigator |
| Robert Gabor Kiss, MD, PhD | State Health Center, Budapest, Hungary | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Health Center | Budapest | 1134 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24732918 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Verapamil | Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL. |
| FG001 | Placebo | Placebo: Intraarterial administration of 10 mL saline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Verapamil | Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL. |
| BG001 | Placebo | Placebo: Intraarterial administration of 10 mL saline. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Access Site Conversions | Posted | Number | participants | Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verapamil | Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Istvan Hizoh, MD, PhD / Senior Consultant | State Health Center, Hungary | +36 1 4651800 | 71773 | ihizoh@web.de |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Intraarterial administration of 10 mL saline. |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
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| Secondary | Rate of Code Breaks | Code break: a composite of access site conversion and unplanned use of vasodilators. | Posted | Number | participants | Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention. |
|
|
|
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| Secondary | Rate of Vasodilator Use | Posted | Number | participants | Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention. |
|
|
|
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| Secondary | Procedural Time | Posted | Median | Inter-Quartile Range | minutes | Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention. |
|
|
|
|
| Secondary | Fluoroscopic Time | Posted | Median | Inter-Quartile Range | minutes | Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention. |
|
|
|
|
| Secondary | Contrast Volume | Posted | Median | Inter-Quartile Range | milliliter | The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention. |
|
|
|
|
| Secondary | Subjective Pain | Analysis of the rates of significant pain defined as pain score ≥4 on a semiquantitative scale ranging from 1 to 6. | Posted | Number | participants | Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention. |
|
|
|
|
| 0 |
| 297 |
| 0 |
| 297 |
| EG001 | Placebo | Placebo: Intraarterial administration of 10 mL saline. | 0 | 294 | 0 | 294 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |