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CompletedNCT01447862Updated May 13, 2015

Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation

A Phase 4 interventional study of Brinavess (Vernakalant) and Corvert (Ibutilide) in Atrial Fibrillation, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-05-13.

Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study summary

Atrial fibrillation is the most common cardiac arrhythmia and is expected to affect about 30 million North Americans and Europeans by 2050. Atrial fibrillation is associated with increased cardiovascular morbidity and mortality, with stroke being an especially important and potentially devastating complication. Many studies have investigated the efficacy of different drugs in converting atrial fibrillation to sinus rhythm. There are numerous randomized controlled trials that have tested the efficacy of agents against placebo and some trials that directly compared the efficacy of two or more different drugs. The class III antiarrhythmic drug Ibutilde is approved for the acute termination of atrial fibrillation and atrial flutter of recent onset and has been shown to be superior to sotalol and equivalent to flecainide in this indication. Recently, the relatively atrial selective antiarrhythmic agent vernakalant has been approved by the European Commission for the rapid conversion of recent onset AF to sinus rhythm in adults. The investigators hypothesize that the period of time needed for cardioversion to sinus rhythm and the efficacy of cardioversion within 90 minutes is different between vernakalant and ibutilide in patients with recent-onset atrial fibrillation.

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Conditions studied

  • Atrial Fibrillation

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Keywords

  • recent-onset
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 101 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Symptoms of atrial fibrillation since no longer than 48 hours
  • Age 18 - 90 years

Exclusion criteria

Exclusion Criteria:

  • Need for immediate electrical cardioversion due to hemodynamic instability (hypotension: systolic blood pressure \< 100 mmHg, dyspnea, loss of consciousness, unstable angina)
  • Moderate to severe heart failure (NYHA III/IV) and patients with previously documented left ventricular ejection fraction (LVEF) ≤ 35%
  • History or signs of acute coronary syndromes (acute myocardial infarction, unstable angina) within the last 30 days
  • Resting ventricular rate \< 80 beats per minute without pace maker back-up
  • QT interval of > 440 milliseconds
  • Wolff-Parkinson-White (WPW) syndrome
  • History of Torsade de pointes arrhythmias or other polymorphic ventricular tachycardias
  • Signs of thyreotoxicosis
  • Sick Sinus Syndrome or atrioventricular block greater than first degree
  • Severe valvular heart disease, clinically meaningful hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
  • Serious disorders of the hepatic, renal (Creatinine > 2.5mg/dl), pulmonary, gastrointestinal, hematologic or central nervous system and serious psychiatric disorders
  • Abnormal serum electrolytes despite adequate therapy (especially potassium \<3.5 mmol/l or > 5.5 mmol/l)
  • Intravenous use of other Class I or III antiarrythmic drugs within 4 hours of study drug application
  • Pregnancy (a β-HCG test will be performed in all female subjects apart from women > 50 years and with amenorrhea for at least 12 month (absence of other causes of amenorrhoea)
  • Known hypersensitivity to study medication
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • Active comparator
    Vernakalant

    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.

    Drug: Brinavess (Vernakalant)

  • Active comparator
    Ibutilide

    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.

    Drug: Corvert (Ibutilide)

Interventions

  • DrugBrinavess (Vernakalant)

    3mg/kg Brinavess (Vernakalant) in 100ml normal saline over 10min. If atrial fibrillation continues after another 15 minutes of observation, patients will receive a second infusion of 2mg/kg Brinavess (Vernakalant) over 10 minutes

  • DrugCorvert (Ibutilide)

    Patients will be given 1mg of Corvert (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 over 10min.

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What researchers measure

Primary outcomes

  1. Time in minutes until conversion to sinus rhythm (measured from the start of the first study drug administration)

    Time frame: 90 minutes

Secondary outcomes

  1. Conversion rate to sinus rhythm within 90 minutes (measured from the start of the first study drug administration)

    Time frame: 90 minutes

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Study locations

1 site
  • Medical University of Vienna, Department of Emergency Medicine
    Vienna, A-1090, Austria
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References and documents

Publications

  • Camm AJ, Capucci A, Hohnloser SH, Torp-Pedersen C, Van Gelder IC, Mangal B, Beatch G; AVRO Investigators. A randomized active-controlled study comparing the efficacy and safety of vernakalant to amiodarone in recent-onset atrial fibrillation. J Am Coll Cardiol. 2011 Jan 18;57(3):313-21. doi: 10.1016/j.jacc.2010.07.046. PubMed 21232669 ↗
  • Domanovits H, Schillinger M, Thoennissen J, Nikfardjam M, Janata K, Brunner M, Laggner AN. Termination of recent-onset atrial fibrillation/flutter in the emergency department: a sequential approach with intravenous ibutilide and external electrical cardioversion. Resuscitation. 2000 Aug 1;45(3):181-7. doi: 10.1016/s0300-9572(00)00180-5. PubMed 10959017 ↗
  • Stiell IG, Dickinson G, Butterfield NN, Clement CM, Perry JJ, Vaillancourt C, Calder LA. Vernakalant hydrochloride: A novel atrial-selective agent for the cardioversion of recent-onset atrial fibrillation in the emergency department. Acad Emerg Med. 2010 Nov;17(11):1175-82. doi: 10.1111/j.1553-2712.2010.00915.x. Erratum In: Acad Emerg Med. 2011 Feb;18(2):224. PubMed 21175515 ↗
  • Simon A, Niederdoeckl J, Skyllouriotis E, Schuetz N, Herkner H, Weiser C, Laggner AN, Domanovits H, Spiel AO. Vernakalant is superior to ibutilide for achieving sinus rhythm in patients with recent-onset atrial fibrillation: a randomized controlled trial at the emergency department. Europace. 2017 Feb 1;19(2):233-240. doi: 10.1093/europace/euw052. PubMed 28175295 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01447862
Lead sponsor
Medical University of Vienna
Responsible party
Hans Domanovits (MD, Medical University of Vienna) — Principal investigator
First posted
Oct 6, 2011
Start date
Oct 2011
Primary completion
May 2015
Completion
May 2015
Last update
May 13, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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