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Atrial FibrillationPhase 3AVRONCT00668759

A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation

A Phase 3 study testing Vernakalant Injection and Amiodarone Injection: in people with Atrial Fibrillation, run by Advanz Pharma at 100 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Vernakalant Injection and Amiodarone Injection:
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
100 sitesin 16 countries
Study dates
Apr 2008to Nov 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

100 sites in 16 countries.

100 sites in 16 countries

Germany17 sites

  • Charite Campus Mitte, Med. Klinik und Poliklinik mit Schwerpunkt Kardiologie und Angiologie

    Berlin, 10117

  • Campus Virchow-Klinikum, Charite - Universitaetsmedizin Berlin

    Berlin

  • Herzzentrum Brandenburg in Bernau Innere Medizin

    Bernau, 16321

  • Universitätsklinikum Bonn, Med. Klinik und Poliklinik II

    Bonn, 53105

  • Klinikum der Universität Köln, Medizinische Klinik III

    Cologne, 50924

  • Johann Wolfgang Goethe Universitaet Med Klinik III - Kardiologie

    Frankfurt

  • Universitatsklinikum Gottingen, Herzzentrum

    Göttingen, 37075

  • Martin-Luther Universitat Halle, Med. Klinik und Poliklinik III- Fachrichtung Kardiologie

    Halle

  • Klinik Hamburg Bambek Kardiologie

    Hamburg, 22291

  • Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

    Hamburg, 22527

  • Medizinische Klinik, Klinikum Hannover Nordstadt

    Hanover

  • Ambulantes Herzzentrum Kassel Innere Medizin

    Kassel, 34121

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

  • Carl-von Basedow-Klinikum Merseburg

    Merseburg, 06217

  • Klinikum Pirna GmbH, Innere Medizin II, Kardiologie

    Pirna

  • Krankenhaus Reinbek, St. Adolf-Stift

    Reinbek

  • Robert-Bosch-Krankenhaus, Abt. Kardiologie / Pulmologie

    Stuttgart, 70376

Other trials in Germany

Czechia12 sites

  • Mestrska nemocnice Caslav

    Čáslav, 286 01

  • Nemocnice Kroměříž

    Kroměříž, 767 55

  • Nemocnice Kutna Hora s.r.o. Interni Oddeleni

    Kutná Hora

  • Nemocnice Decin Internal Medicine

    Nove Město, 405 02

  • Fakultní nemocnice v Motole, KAR

    Prague, 150 00

  • Ustredni vojenska nemocnice Koronarni jednotka

    Prague, 162 00

  • VFN - III. Interni Klinika

    Prague

  • Oblastni nemocnice Pribram Interni Oddeleni

    Příbram

  • Nemocnice v Semilech Interní oddělení

    Semily

  • Nemocnice Slaný Interní oddělení

    Slaný

  • Nemocnice Tabor

    Tábor, 390 03

  • Uherskohradistska nemocnice

    Uherské Hradiste, 686 08

Other trials in Czechia

Poland12 sites

  • Oddzial Kardiologiczny Wielospecjalityczny Szpital Miejski im.

    Bydgoszcz

  • Szpital Miejski im. J. Brudzinskiego Oddzial Kardiologii

    Gdynia

  • Klinika Chorob Wewnetrznych z Oddzialem Farmakologii Klinicznej i Terapii Monitorowanej

    Lodz

  • Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Szpital Wojewódzki im. Jana Bożego w Lublinie

    Lublin, 20-089

  • Okregowy Szpital Kolejowy w Lublinie Samodzielny

    Lublin

  • Oddzial Kardiologii Inwazyjnej Szpital Specjalistyczny im. E.Szczeklika w Tarnowie

    Tarnów, 33-100

  • Oddział Kardiologiczno-Internistyczny Specjalistyczny Szpital Miejski im. Mikołaja Kopernika

    Torun, 87-100

  • Specjalistyczny Szpital Miejski im. Mikołaja Kopernika

    Torun, 87-100

  • III Klinika Chorob Wewnetrznych i Kardiologii

    Warsaw, 00-382

  • Wojskowy Instytut Medyczny, CSK MON

    Warsaw, 00-909

  • Klinika Kardiologii Zachowawczej Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie

    Warsaw, 02-507

  • Osrodek Chorob Serca, Klinika Kardiologii, 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny

    Wroclaw

Other trials in Poland

Slovakia8 sites

  • Middle Slovak Institute of Cardiovascular Diseases (SUSCCH)

    Banska Bysterica, 97401

  • NsP Prievidza so sidlom v Bojniciah

    Bojnice, 97201

  • Slovensky ustav srdcovych a cevnych chorob

    Bratislava, 83348

  • ICU, Hospital Lipt. Mikulas

    Liptovský Mikuláš, 03101

  • FN - I. interna klinika

    Nitra, 950 01

  • Liva - Central Military Hospital

    Ružomberok, 03401

  • Interna klinika FN Trnava, Fakultna nemocnica Trnava

    Trnava, 91701

  • Internal Dep. Hospital Žilina

    Žilina, 012 07

Other trials in Slovakia

Ukraine8 sites

  • Donetsk Regional Clinical Hospital

    Donetsk

  • City Clinical Hospital #8

    Kharkiv

  • City Clinical Hospital #1 Intensive Care Unit

    Kiev

  • Kiev City Clinical Hospital No 5, Coronary Care Unit

    Kiev

  • N.D. Strazhesko Institute of Cardiology Intensive Care Unit

    Kiev

  • Lugansk First Clinical Multiprofile Hospital #1, Cardiology

    Luhansk

  • Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre Dept of Myocardial Infarction

    Lviv

  • City Clinical Hospital #9 Dept of Arrhythmia

    Odesa

Other trials in Ukraine

Canada7 sites

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Hopital de la Cite-de-la-Sante

    Laval, Quebec, H7M 3L9

  • Institut de Cardiologie de Montreal

    Montreal, Quebec, H1T 1C8

  • Centre Hopitalier de L'Universite de Montreal - Hotel Dieu

    Montreal, Quebec, H2W 1T8

  • McGill University Health Center The Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y 4E9

  • Centre de santé et de services sociaux du Sud de Lanaudière - Hôpital Pierre-Le Gardeur

    Terrebonne, Quebec, J6V 2H2

Other trials in Canada

Netherlands7 sites

  • WCN - Department of Cardiology Rijnstate Ziekenhuls

    Arnhem, 6-800 TA

  • Catharina Ziekenhuis Eindhoven

    Eindhoven, 5623EJ

  • Groene Hart Zeikenhhaus

    Gouda, 2800BB

  • WCN - Bethesda ziekenhuis

    Hoogeveen, 7909 AA

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6229 HX

  • WCN - Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ

  • WCN - St. Franciscus Gasthuis

    Rotterdam, 3045 PM

Other trials in Netherlands

Denmark5 sites

  • Gentofte Amtssygehus Kardiologisk afdeling

    Hellerup

  • Herlev Amtssygehus, Kardiologisk

    Herlev, 2730

  • Sygehus Vendsyssel Hjorring

    Hjørring

  • Roskilde Amts Sygehus Køge

    Køge

  • Regionshospitalet Silkeborg

    Silkeborg

Other trials in Denmark

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Hobart Hospital Cardiology Research

    Hobart, Tasmania, 7000

  • Launceston General Hospital Cardiac Research Unit

    Launceston, Tasmania

  • Royal Perth Hospital Emergency Research

    Perth, Western Australia, 6000

Other trials in Australia

Estonia4 sites

  • Viimsi Hospital, Heart Clinic

    Haabneeme, 74001

  • Pärnu Hospital Department of Cardiology

    Pärnu

  • East Tallinn Central Hospital-Clinic of Cardiology

    Tallinn

  • Tartu University Hospital Heart Clinic

    Tartu

Other trials in Estonia

France4 sites

  • Hopital Trousseau - Service de Cardiologie

    Chambray-lès-Tours

  • CHU de Nancy - Hopital Brabois - Service de Cardiologie

    Nancy

  • Hôpital Lariboisiere

    Paris

  • CHU de Strasbourg - Hopital Hautepierre - Service de Cardiologie

    Strasbourg

Other trials in France

Serbia4 sites

  • Clinical Center of Serbia, Institute of CV Diseases

    Belgrade, 11000

  • "Dedinje" Cardiovascular Institute

    Belgrade, 11040

  • Institute of Treatment and Reahabilitation 'Niska Banja'

    Niška Banja, 18205

  • Clinical Center Zemun, Dept. of Cardiology

    Zemun, 11080

Other trials in Serbia

Lithuania3 sites

  • Kaunas Medical University Hospital - Department of Cardiology

    Kaunas

  • Klaipeda Seamen's Hospital

    Klaipėda

  • Vilnius University Hospital Santariskiu Clinic - Center of Cardiology and Angiology

    Vilnius

Other trials in Lithuania

Sweden3 sites

  • Universitetssjukhuset MAS

    Malmö

  • Universityetssjukhuset, Orebro

    Örebro

  • Akademiska Sjukhuset, Uppsala

    Uppsala

Other trials in Sweden

Finland1 site

  • Oulu University Hospital - Dept of Internal Medicine

    Oulu, 90014

Other trials in Finland

Latvia1 site

  • Latvian Center of Cardiology, P. Stradins Clinical University Hospital

    Riga, LV1002

Other trials in Latvia

About this study

Official 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

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.

Read the detailed description

This is a double-blind, active-controlled, double-dummy, multi-center, randomized trial in subjects with symptomatic AF of 3 to 48 hours duration.

Subjects will be randomized to receive vernakalant injection or amiodarone injection in a 1:1 ratio.

Safety will be assessed through the monitoring of adverse events, vital signs, continuous telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.

At 2 hours after the start of infusion, electrical cardioversion may be performed or rate control medication may be administered. Class I and Class III antiarrhythmics are not to be administered for 24 hours after the start of infusion.

Subjects are to remain in the clinic for at least 6 hours after the start of infusion. Subjects will attend a follow-up visit at 7 (±2) days after treatment and will receive a follow-up telephone call at 30 (±3) days for assessment of serious adverse events, concomitant medications related to serious adverse events, and recurrence of AF.

All roles were blinded with the exception of each site's designated unblinded personnel who were responsible for randomization and preparation, dispensation and accountability of the study medication.

Expanded Access was not available through this protocol.

Being tested
Vernakalant Injection, Amiodarone Injection:
Keywords
atrial fibrillation, atrial fib, AF
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vernakalant InjectionDrug

    Also called RSD1235, Kynapid

    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).

  • Amiodarone Injection:Drug

    Also called Amiodarone, Cordarone

    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).

Study groups in NCT00668759
Study groupRoleWhat they receive
1ExperimentalVernakalant 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.
Receives: Drug: Vernakalant Injection
2Active comparatorAmiodarone 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.
Receives: Drug: Amiodarone Injection:

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with conversion of atrial fibrillation to sinus rhythm within 90 minutes after the start of infusion.

    Measured: Conversion of AF to SR for a minimum duration of one minute within 90 minutes after start of infusion.

Secondary outcomes (4)

  1. Time to conversion within 90 minutes after the start of infusion.

    Measured: Time to conversion of AF to SR within 90 minutes after start of infusion.

  2. Proportion of subjects with symptom relief at 90 minutes after the start of infusion.

    Measured: Relief of AF symptoms 90 minutes after start of infusion.

  3. EQ-5D quality of life assessment.

    Measured: Assessment of quality of life 2 hours after start of infusion.

  4. Monitoring of adverse events, vital signs, continuous telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionOct 2009
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00668759
Sponsor's protocol ID
VERI-305-AMIO
Acronym
AVRO
Status last verified
Dec 2009
First submitted
25 Apr 2008
Last updated
15 Dec 2009
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vernakalant Injection and Amiodarone Injection: in people with Atrial Fibrillation, run by Advanz Pharma at 100 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in Germany, Czechia, Poland, Slovakia, Ukraine and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with conversion of atrial fibrillation to sinus rhythm within 90 minutes after the start of infusion. (time frame: Conversion of AF to SR for a minimum duration of one minute within 90 minutes after start of infusion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00668759, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2009.

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