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Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01447862
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Hans Domanovits, Medical University of Vienna

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Brinavess (Vernakalant) Drug: Corvert (Ibutilide) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation
Study Start Date : October 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)
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
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)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Time in minutes until conversion to sinus rhythm (measured from the start of the first study drug administration) [ Time Frame: 90 minutes ]

Secondary Outcome Measures :
  1. Conversion rate to sinus rhythm within 90 minutes (measured from the start of the first study drug administration) [ Time Frame: 90 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447862


Locations
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Austria
Medical University of Vienna, Department of Emergency Medicine
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hans Domanovits, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01447862    
Other Study ID Numbers: Verna-Ibu-AF
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Hans Domanovits, Medical University of Vienna:
recent-onset
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Ibutilide
Anti-Arrhythmia Agents