Clinical Trial Results:
Vernakalant is superior to ibutilide for achieving sinus rhythm in patients with recent-onset atrial fibrillation: a randomized controlled trial at the emergency department
Summary
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EudraCT number |
2011-000695-34 |
Trial protocol |
AT |
Global end of trial date |
12 May 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
06 May 2020
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First version publication date |
06 May 2020
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Other versions |
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Summary report(s) |
Vernakalant is superior to ibutilide for achieving sinus rhythm in patients with recent-onset atrial fibrillation |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Verna-Ibu-AF_1.0
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01447862 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University Vienna
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Sponsor organisation address |
Waehringer Guertel 18 - 20, Vienna, Austria, 1090
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Public contact |
Alexander Spiel, Medical University of Vienna, Department of Emergency Medicine, +43 1404003953, alexander.spiel@meduniwien.ac.at
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Scientific contact |
Alexander Spiel, Medical University of Vienna, Department of Emergency Medicine, +43 1404003953, alexander.spiel@meduniwien.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 May 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 May 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
12 May 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To compare the time duration and the efficacy of cardioversion between the two rapid-acting antiarrhythmic drugs vernakalant and ibutilide in patients with recent-onset atrial fibrillation admitted to the emergency medicine ward of a tertiary care hospital.
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Protection of trial subjects |
According to data from the literature, vernakalant and ibutilide will lead to a cardioversion rate of approximately 50% in our study subjects. As we are aware of possible side effects of both ibutilide (especially ventricular arrhythmias/tachycardias, bundle branch blocks, atrioventricular blocks) and vernakalant (especially hypotension, bradycardia, dizziness, dysgeusia, sneezing, coughing) we will minimize the risk for side effects by appropriate exclusion criteria, by close monitoring (continuous saturation and ECG, blood pressure) of all participants and by providing all measures for adverse event management. Altogether, we assume a positive benefit/risk ratio.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 May 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
100
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
59
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From 65 to 84 years |
40
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85 years and over |
1
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Recruitment
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Recruitment details |
101 patients who have been admitted to the Emergency Department because of recent-onset atrial fibrillation (< 48h) have been recruited. | |||||||||||||||
Pre-assignment
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Screening details |
All patients, presenting to the emergency departement with symptoms of atrial fibrillation since no longer than 48 hours have been screened for potential enrollment. | |||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ibutilide | |||||||||||||||
Arm description |
Ibutilide has been used as an active comparator to Vernakalant | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Corvert
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Investigational medicinal product code |
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Other name |
Ibutilide
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Patients will be given 1mg of ibutilide in 100ml normal saline intravenously over 10min. If atrial fibrillation continues after another 10 minutes of observation, patients will receive a second infusion of 1mg ibutilide, again over 10min. If the initial rhythm has not converted to sinus rhythm after 2 hours, consented patients will be treated with electrical cardioversion using a standard routine protocol.
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Arm title
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Vernakalant | |||||||||||||||
Arm description |
Vernakalant has been used as the drug to be investigated, compared to ibutilide. | |||||||||||||||
Arm type |
Drug to be investigated | |||||||||||||||
Investigational medicinal product name |
Brinavess
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Investigational medicinal product code |
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Other name |
Vernakalant
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
Initially, patients will be given 3mg/kg Vernakalant in 100ml normal saline over 10min. If atrial fibrillation continues after another 15 minutes of observation, patients will receive a second infusion of Vernakalant (2mg/kg), again over 10 minutes. If the initial rhythm has not converted to sinus rhythm after 2 hours, consented patients will be treated with electrical cardioversion using a standard routine protocol.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Vernakalant
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Patients received Vernakalant
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Subject analysis set title |
Ibutilide
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Subjects receiving Ibutilide
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End points reporting groups
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Reporting group title |
Ibutilide
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Reporting group description |
Ibutilide has been used as an active comparator to Vernakalant | ||
Reporting group title |
Vernakalant
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Reporting group description |
Vernakalant has been used as the drug to be investigated, compared to ibutilide. | ||
Subject analysis set title |
Vernakalant
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Patients received Vernakalant
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Subject analysis set title |
Ibutilide
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Subjects receiving Ibutilide
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End point title |
Time in minutes conversion to sinus rhythm | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
1 to 240 minutes
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Statistical analysis title |
Primary endpoint statistic | ||||||||||||
Comparison groups |
Ibutilide v Vernakalant
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.05 | ||||||||||||
Method |
Logrank | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Time during hospital stay
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
15
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Reporting groups
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Reporting group title |
Ibutilide
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Reporting group description |
Patients treated with ibutilide | ||||||||||||||||||||||||||||||
Reporting group title |
Vernakalant
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Reporting group description |
Patients treated with vernakalant | ||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |