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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00668759




Registration number
NCT00668759
Ethics application status
Date submitted
25/04/2008
Date registered
29/04/2008
Date last updated
15/12/2009

Titles & IDs
Public title
A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation
Scientific title
A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection Versus Amiodarone in Subjects With Recent Onset Atrial Fibrillation
Secondary ID [1] 0 0
VERI-305-AMIO
Universal Trial Number (UTN)
Trial acronym
AVRO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vernakalant Injection
Treatment: Drugs - Amiodarone Injection:

Experimental: 1 - Vernakalant Injection:
In one infusion line, subjects will receive a 10-minute infusion of vernakalant followed by a 15-minute observation period, followed by an additional 10-minute infusion of vernakalant if required (if the subject is still in AF). To maintain blinding, a 60-minute infusion of placebo (D5W) will be administered in a second infusion line, followed by a maintenance infusion of placebo for a minimum of an additional 60 minutes.

Active Comparator: 2 - Amiodarone Injection:
In one infusion line subjects will receive a 60-minute infusion of amiodarone followed by a maintenance infusion of amiodarone over an additional 60 minutes. To maintain blinding, a 10-minute infusion of placebo (normal saline) will be administered in a second infusion line, followed by a 15 minute observation period, followed by a 10 minute infusion of placebo if the subject is still in AF.


Treatment: Drugs: Vernakalant Injection
10-minute infusion of 3 mg/kg vernakalant injection followed by a 15-minute observation period, followed by an additional 10-minute infusion of 2 mg/kg of vernakalant if required (if the subject is still in AF).

Treatment: Drugs: Amiodarone Injection:
60-minute infusion of 5 mg/kg amiodarone followed by a maintenance infusion of 50 mg amiodarone over an additional 60 minutes (equivalent to approximately 15 mg/kg over 24 hrs).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with conversion of atrial fibrillation to sinus rhythm within 90 minutes after the start of infusion.
Timepoint [1] 0 0
Conversion of AF to SR for a minimum duration of one minute within 90 minutes after start of infusion.
Secondary outcome [1] 0 0
Time to conversion within 90 minutes after the start of infusion.
Timepoint [1] 0 0
Time to conversion of AF to SR within 90 minutes after start of infusion.
Secondary outcome [2] 0 0
Proportion of subjects with symptom relief at 90 minutes after the start of infusion.
Timepoint [2] 0 0
Relief of AF symptoms 90 minutes after start of infusion.
Secondary outcome [3] 0 0
EQ-5D quality of life assessment.
Timepoint [3] 0 0
Assessment of quality of life 2 hours after start of infusion.
Secondary outcome [4] 0 0
Monitoring of adverse events, vital signs, continuous telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.
Timepoint [4] 0 0
Specified safety assessments completed at specified time points throughout the study from Screening to Discharge, at the Day 7 visit, and at the Day 30 follow-up call.

Eligibility
Key inclusion criteria
Key

- Have symptomatic AF of 3 to 48 hours duration at baseline.

- Be eligible for cardioversion.

- Have adequate anticoagulation therapy for cardioversion in accordance with standard of
practice as recommended by ACC/AHA/ESC guidelines [1].

- Be hemodynamically stable and have systolic blood pressure (BP) above 100 mmHg and
less than 160 mmHg and diastolic BP less than 95 mmHg at screening and baseline.

Key
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known or suspected prolonged QT or uncorrected QT interval of >440 msec as measured at
screening on a 12 lead ECG, familial long QT syndrome, or previous torsades de
pointes, ventricular fibrillation; or sustained ventricular tachycardia (VT).

- Symptomatic bradycardia, sick sinus syndrome, or ventricular rate less than 50 beats
per minute (bpm) as documented by 12-lead ECG at screening.

- A QRS interval >140 msec.

- Atrial flutter.

- Significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive
cardiomyopathy or constrictive pericarditis.

- Documented previous episodes of second or third degree atrioventricular (AV) block.

- Had a myocardial infarction (MI), acute coronary syndrome or cardiac surgery within 30
days prior to entry into the study.

- Uncorrected electrolyte imbalance of serum potassium or magnesium. Both K+ and Mg2+
must be corrected prior to dosing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2009
Sample size
Target
Accrual to date
Final
254
Recruitment in Australia
Recruitment state(s)
SA,TAS,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Hobart Hospital Cardiology Research - Hobart
Recruitment hospital [3] 0 0
Launceston General Hospital Cardiac Research Unit - Launceston
Recruitment hospital [4] 0 0
Royal Perth Hospital Emergency Research - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
- Launceston
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
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Canada
State/province [2] 0 0
Quebec
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Czech Republic
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Caslav
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Czech Republic
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Kromeríž
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Czech Republic
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Kutna Hora
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Czech Republic
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Nove Mesto
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Czech Republic
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Praha
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Czech Republic
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Pribram
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Czech Republic
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Semily
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Czech Republic
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Slaný
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Czech Republic
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Tabor
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Czech Republic
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Uherské Hradiste
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Denmark
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Hellerup
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Denmark
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Herlev
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Denmark
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Hjorring
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Denmark
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Koge
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Denmark
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Silkeborg
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Estonia
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Haabneeme
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Estonia
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Parnu
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Estonia
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Tallinn
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Estonia
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Tartu
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Finland
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Oulu
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France
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Chambray-les-Tours
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France
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Nancy
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France
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Paris
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France
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Strasbourg
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Germany
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Berlin
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Germany
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Bernau
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Germany
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Bonn
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Germany
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Frankfurt
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Germany
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Gottingen
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Germany
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Halle
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Kassel
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Germany
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Köln
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Germany
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Ludwigshafen
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Germany
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Merseburg
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Germany
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Pirna
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Germany
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Reinbek
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Germany
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Stuttgart
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Latvia
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Riga
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Netherlands
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Arnhem
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Eindhoven
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Gouda
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Hoogeveen
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Maastricht
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Nijmegen
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Netherlands
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Rotterdam
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Poland
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Bydgoszcz
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Poland
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Gdynia
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Lodz
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Lublin
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Tarnow
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Torun
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Warszawa
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Wroclaw
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Serbia
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Belgrade
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Serbia
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Niska Banja
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Serbia
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Zemun
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Slovakia
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Banska Bysterica
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Slovakia
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Bojnice
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Bratislava
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Slovakia
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Liptovsky Mikulas
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Nitra
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Slovakia
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Ruzomberok
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Slovakia
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Trnava
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Slovakia
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Žilina
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Sweden
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Malmo
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Sweden
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Orebro
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Sweden
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Uppsala
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Kiev
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Ukraine
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Lugansk
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Ukraine
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Lviv
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Ukraine
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Odessa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Advanz Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to demonstrate the superiority of vernakalant injection
over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR)
within 90 minutes of the start of drug administration. The secondary objective is to compare
the safety of vernakalant to amiodarone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00668759
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tomas Janota, MD
Address 0 0
VFN III. interní klinika
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00668759