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Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Brinavess (Vernakalant)
Corvert (Ibutilide)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring recent-onset

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna, Department of Emergency Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vernakalant

Ibutilide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2011
Last Updated
May 12, 2015
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01447862
Brief Title
Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation
Official Title
Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
recent-onset

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vernakalant
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ibutilide
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Brinavess (Vernakalant)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Corvert (Ibutilide)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time in minutes until conversion to sinus rhythm (measured from the start of the first study drug administration)
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Conversion rate to sinus rhythm within 90 minutes (measured from the start of the first study drug administration)
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Medical University of Vienna, Department of Emergency Medicine
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
21232669
Citation
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.
Results Reference
background
PubMed Identifier
10959017
Citation
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.
Results Reference
background
PubMed Identifier
21175515
Citation
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.
Results Reference
background
PubMed Identifier
28175295
Citation
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.
Results Reference
derived

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Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation

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