Coronary DiseaseVITRIOLNCT01402427
Is Verapamil In TransRadial Interventions OmittabLe?
A study testing Verapamil in people with Coronary Disease and Verapamil Toxicity, run by State Health Center, Hungary at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Verapamil Toxicity
- What is being tested?
- Verapamil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 591 participants
- Where
- 1 siteHungary
- Study dates
- Mar 2011to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing transradial coronary angiography and/or percutaneous coronary intervention
- successful cannulation of the radial artery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions
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
- Being tested
- Verapamil, Placebo
- Keywords
- Coronary Artery Disease, Coronary Angiography, Percutaneous Coronary Intervention, Transradial, Radial Artery Spasm, Verapamil, Adverse Effects
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerapamilDrug
Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
PlaceboDrug
Intraarterial administration of 10 mL saline.
| Study group | Role | What they receive |
|---|---|---|
| Verapamil | Active comparator | Not described Receives: Drug: Verapamil |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Access Site Conversions
Measured: 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
Code break: a composite of access site conversion and unplanned use of vasodilators.
Measured: Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.
Rate of Vasodilator Use
Measured: Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.
Procedural Time
Measured: Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.
Fluoroscopic Time
Measured: Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.
Contrast Volume
Measured: 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.
Measured: Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Health Center, Hungary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Istvan Hizoh, MD, PhD, State Health Center, Hungary
- Investigators
- Istvan Hizoh, MD, PhD, Principal investigator, State Health Center, Budapest, HungaryRobert Gabor Kiss, MD, PhD, Study chair, State Health Center, Budapest, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402427
- Sponsor's protocol ID
- SHCCARD-001
- Acronym
- VITRIOL
- Status last verified
- Apr 2014
- First submitted
- 21 Jul 2011
- Last updated
- 2 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24732918
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions
- ClinicalTrials.gov ID
- NCT01402427
- Acronym / sponsor ID
- VITRIOL / SHCCARD-001
- Conditions
- Coronary Disease, Verapamil Toxicity
- Keywords
- Coronary Artery Disease, Coronary Angiography, Percutaneous Coronary Intervention, Transradial, Radial Artery Spasm, Verapamil, Adverse Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- State Health Center, HungaryUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Posted 2 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verapamil | Active comparator | Drug: Verapamil |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing transradial coronary angiography and/or percutaneous coronary intervention
- successful cannulation of the radial artery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VerapamilIntraarterial administration of 5 mg verapamil diluted with saline to 10 mL. | Drug | Verapamil |
| PlaceboIntraarterial administration of 10 mL saline. | Drug | Placebo |
Primary outcome
Rate of Access Site Conversions
Time frame: Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.
6 secondary outcomes
Rate of Code Breaks
Time frame: Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.
Rate of Vasodilator Use
Time frame: Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.
Procedural Time
Time frame: Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.
Fluoroscopic Time
Time frame: Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.
Contrast Volume
Time frame: The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.
Subjective Pain
Time frame: Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24732918Hizoh 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Istvan Hizoh, MD, PhD principal investigator
State Health Center, Budapest, Hungary
Robert Gabor Kiss, MD, PhD study chair
State Health Center, Budapest, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verapamil in people with Coronary Disease and Verapamil Toxicity, run by State Health Center, Hungary at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Access Site Conversions (time frame: Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01402427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.