Atrial FibrillationPhase 4NCT00408473
Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation.
A Phase 4 study testing Flecainide in people with Atrial Fibrillation, run by MEDA Pharma GmbH & Co. KG at 47 sites in 7 countries.
Trial summary
The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in the prevention of recurrent AF during 9 months of active treatment compared to placebo in patients with only one documented AF episode. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Flecainide
- How many people
- 256 participants
- Where
- 47 sitesin 7 countries
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of first symptomatic \& documented episode of AF
- LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment
Who cannot join
- History of more than 1 symptomatic documented AF episode, persistent or permanent AF.
- History of ablation for previous AF
- Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery
- Severe symptoms during AF episode (e.g.syncope, chest pain)
- All types of treated arrhythmias other than AF
- History of myocardial infarction (MI), coronary artery disease (CAD), heart failure (I, II, III and IV of New York Heart Association -NYHA- classification) or valvular diseases
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- Left ventricular ejection fraction (LVEF) ≤ 40%
- Bradycardia < 40 beats/min and all ECG abnormalities: PR> 240ms or QRS> 120 ms or QTc> 440 ms
- Brugada syndrome
- Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block
- 2nd or 3rd degree atrioventricular (AV) block
- Sinus node dysfunction
- Severe hypertension with:Systolic blood pressure ≥ 180 mmHg, and / or· Diastolic blood pressure ≥ 100 mmHg
- Left ventricular hypertrophy (LVH) with septal thickness > 14 mm on Echocardiogram
- Implanted pacemaker
- Heart surgery within the last 6 months, or non-stable postoperative condition
- Renal failure: serum creatinine ≥ 150 µmol/l or creatinine clearance ≤ 50 ml/min (Cockroft and Gault formula
- Uncorrected electrolytic abnormalities
- Have used recently in the last 3 months prior to the inclusion any of the following treatments: Oral amiodarone, Treatments that lengthen QT interval (e.g.Sultopride, Drugs causing torsades de pointe (e.g.mizolastine, pentamidine, sparfloxacin, moxifloxacin, Bupropion
- Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB
Trial locations and contacts
47 sites in 7 countries.
47 sites in 7 countries
France18 sites
Centre Hospitalier Général, 22, boulevard Général Sibille
Albi, 81,000
Hôpital d'Arras service de cardiologie, 57 avenue Wiston Churchill
Arras, 62000
Philippe CHEMIN, 49 rue du Bocage
Bordeaux, 33,200
Hopital d'instruction des armées, rue Colonel Fonferrier
Brest, 29200
Centre Hospitalier Général, 516 avenue de Paris
Cambrai, 59,407
Patrick GIRAUD, Bat C 132 av Gabriel Péri
Cavaillon, 84300
André CORBIN, 28 rue du Conte de la Garaye
Dinan, 22,100
Centre Hospitalier du Leman, 3 avenue de la dame
Evian-thonon, 74203
Verschuersen Iordanka, 4 rue Béranger
Fontainebleau, 77300
Hôpital de Freyming Merlebach- Service de Cardiologie, 2 rue de France
Freyming-Merlebach, 57 804
Centre Hospitalier Général, 10 rue de la Charité
Langres, 52200
Jean Claude GICHTENAERE, 8 quai du Général Leclerc
Martigues, 13,500
CHI Montfermeil, 10 rue du Gal Leclerc
Montfermeil, 93370
Résidence Médicale Les Roses, 57, route de Lavérune
Montpellier, 34070
Patrick KOHAN, 18 rue de la Commanderie
Nancy, 54000
Centre Hospitalier Regional, 1 rue du Friscaty
Thionville, 57126
Hôpital d'Instruction des Armées Sainte Anne, Boulevard Sainte Anne
Toulon, 83,100
Centre médical, Promenade du petit Languedoc
Villefranche-de-Rouergue, 12200
Bulgaria10 sites
Department of Cardiology, MHAT Burgas AD, 73 Stefan Stambolov blvd
Burgas, 8000
Cardiology Clinic and ICU, UMHAT "Dr. Georgi Stranski" EAD, 8a Georgi Kochev Str
Pleven, 5800
Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str
Rousse, 7002
Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd
Sofia, 1202
National Cardiology Hospital EAD, 65 Konjovitza Str.
Sofia, 1309
Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str
Sofia, 1431
Clinic of Cardiology, University Hospital 'Queen Giovanna', 8 Bialo More str
Sofia, 1504
Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str
Sofia, 1606
Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd
Sofia, 1606
CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd
Varna, 9010
Germany6 sites
Zentralklinic Bad Berka Gmbr Klinic fur Kardiologie- Leitender Arzt der Avteilung - Rhythmologie und invasive Elektrophysiologie, Robert Koch Allee 9
Bad Berka, 99437
Director of Electrophysiology Laboratory - Department of Medicine - Cardiology- University of Bonn, Sigmund Freud Str 25 -
Bonn, D53105
Klinikum Coburg , Ketschendorfer Str. 33
Coburg, D-96450
Div Cardiology; University Hospital , Leipzigen St 44 -
Magdeburg, 39120
Oberarzt Medizinische Klinik und Poliklinik C IZKF Münster Kompetenznetzt Vorhofflimmern Universitätsklinikum Münster, Albert-Schweitzer-Straße 33,
Münster, D-48129
Kardiologische Praxis, Magirusstr.49
Ulm, D 89077
Romania6 sites
SPITALUL JUDETEAN-SECTIA CARDIOLOGIE, BRASOV, Str. Independentei Nr. 1
Brasov, 500157
"SPITALUL CLINIC DE URGENTA ""ELIAS""-Clinica de Cardiologie, Str. Marasti, Nr. 17, sect 1
Bucharest, 011461
Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2
Bucharest, 020125
"SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50
Cluj-Napoca, 400347
Centrul de Cardiologie , Str. Tabaci No. 1
Craiova, 200642
CARDIO EXPERT, Str. Romulus, Nr. 62.
Timișoara, 300203
Belgium5 sites
Imeldaziekenhuis, Imeldalaan 9
Bonheiden, 2820
Hôpital St.-Joseph, Rue de la Duchère 6
Gilly, B-6060
Virga Jesse Ziekenhuis, Stadsomvaart 11
Hassel, B - 3500
Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105
Leuven, B - 3000
Clinique Sainte-Elisabet, Place Louise Godin 1
Namur, B - 5000
Netherlands1 site
"Academisch Ziekenhuis Maastricht, P. Debyelaan 25
Maastricht, 6229 HX
About this study
Official title: A Randomised Double-blind Pilot Study Comparing Flecainide CR and Placebo in the Early Treatment of Patients With a Documented First Episode of Atrial Fibrillation.
The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in the prevention of recurrent AF during 9 months of active treatment compared to placebo in patients with only one documented AF episode.
- Conditions
- Atrial Fibrillation
- Being tested
- Flecainide
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlecainideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording.
Secondary outcomes (5)
Total number of AF recurrences during the treatment period
Total number of patients in sinus rhythm at the end of the study
AF Burden
Number of emergency admissions due to AF recurrence
Cardiac Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 256 participants
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Investigators
- Prof E Aliot, Principal investigator, CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408473
- Sponsor's protocol ID
- 1556-FLEC
- Status last verified
- Feb 2007
- First submitted
- 6 Dec 2006
- Last updated
- 7 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Pilot Study Comparing Flecainide CR and Placebo in the Early Treatment of Patients With a Documented First Episode of Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT00408473
- Acronym / sponsor ID
- 1556-FLEC
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 256 participants
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- First posted
- 7 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in the prevention of recurrent AF during 9 months of active treatment compared to placebo in patients with only one documented AF episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of first symptomatic \& documented episode of AF
- LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment
Key exclusion criteria (20 listed)
- History of more than 1 symptomatic documented AF episode, persistent or permanent AF.
- History of ablation for previous AF
- Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery
- Severe symptoms during AF episode (e.g.syncope, chest pain)
- All types of treated arrhythmias other than AF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flecainide | Drug | – |
Primary outcome
Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording.
5 secondary outcomes
Total number of AF recurrences during the treatment period
Total number of patients in sinus rhythm at the end of the study
AF Burden
Number of emergency admissions due to AF recurrence
Cardiac Safety
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof E Aliot principal investigator
CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE
47 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flecainide in people with Atrial Fibrillation, run by MEDA Pharma GmbH & Co. KG at 47 sites in 7 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 2 inclusion and 20 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: stopped early, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in France, Bulgaria, Germany, Romania, Belgium and 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2022.