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Is Verapamil In TransRadial Interventions OmittabLe? (VITRIOL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Istvan Hizoh, MD, PhD, State Health Center, Hungary
ClinicalTrials.gov Identifier:
NCT01402427
First received: July 21, 2011
Last updated: April 30, 2014
Last verified: April 2014
Results First Received: April 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator)
Conditions: Coronary Disease
Verapamil Toxicity
Interventions: Drug: Verapamil
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Verapamil Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
Placebo Placebo: Intraarterial administration of 10 mL saline.

Participant Flow:   Overall Study
    Verapamil     Placebo  
STARTED     297     294  
COMPLETED     297     294  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Verapamil Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
Placebo Placebo: Intraarterial administration of 10 mL saline.
Total Total of all reporting groups

Baseline Measures
    Verapamil     Placebo     Total  
Number of Participants  
[units: participants]
  297     294     591  
Age  
[units: years]
Mean ± Standard Deviation
  61.8  ± 10.5     62.5  ± 10.8     62.1  ± 10.7  
Gender  
[units: participants]
     
Female     111     104     215  
Male     186     190     376  
Region of Enrollment  
[units: participants]
     
Hungary     297     294     591  



  Outcome Measures
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1.  Primary:   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. ]

2.  Secondary:   Rate of Code Breaks   [ Time Frame: Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention. ]

3.  Secondary:   Rate of Vasodilator Use   [ Time Frame: Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention. ]

4.  Secondary:   Procedural Time   [ Time Frame: Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention. ]

5.  Secondary:   Fluoroscopic Time   [ Time Frame: Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention. ]

6.  Secondary:   Contrast Volume   [ Time Frame: The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention. ]

7.  Secondary:   Subjective Pain   [ Time Frame: Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Istvan Hizoh, MD, PhD / Senior Consultant
Organization: State Health Center, Hungary
phone: +36 1 4651800 ext 71773
e-mail: ihizoh@web.de


Publications of Results:

Responsible Party: Istvan Hizoh, MD, PhD, State Health Center, Hungary
ClinicalTrials.gov Identifier: NCT01402427     History of Changes
Other Study ID Numbers: SHCCARD-001
Study First Received: July 21, 2011
Results First Received: April 17, 2014
Last Updated: April 30, 2014
Health Authority: Hungary: Institutional Ethics Committee