Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
NCT ID: NCT01151137
Last Updated: 2012-10-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
3236 participants
INTERVENTIONAL
2010-07-31
2011-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation \[AF\] and additional risk factors
Secondary Objective:
* Demonstrate the efficacy of Dronedarone in preventing cardiovascular death
This was an event-driven study where a common study end date \[CSED\] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A final follow-up visit had to occur within 1 month after the CSED.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dronedarone
Dronedarone 400 mg twice a day until the CSED
Dronedarone
Film-coated tablet
Oral administration under fed conditions (during breakfast and dinner)
placebo
Placebo (for Dronedarone) twice a day until the CSED
Placebo (for Dronedarone)
film-coated tablet strictly identical in appearance
Oral administration under fed conditions (during breakfast and dinner)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dronedarone
Film-coated tablet
Oral administration under fed conditions (during breakfast and dinner)
Placebo (for Dronedarone)
film-coated tablet strictly identical in appearance
Oral administration under fed conditions (during breakfast and dinner)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Availability of one 12-lead ECG not more than 14 days prior to randomization showing that the patient is in AF or atrial flutter;
* Availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in AF or atrial flutter at least 6 months prior to randomization;
* No evidence of sinus rhythm in the period between these two documentations of AF;
* Decision of the patient and physician to allow AF to continue without further efforts to restore sinus rhythm.
* At least one of the following risk criteria:
* Coronary artery disease;
* Prior stroke or Transient Ischemic Attack \[TIA\];
* Symptomatic heart failure;
* Left ventricular ejection fraction \[LVEF\] less or equal to 0.40;
* Peripheral arterial occlusive disease;
* Aged 75 years or older with both hypertension and diabetes mellitus.
Exclusion Criteria
* Persistent AF without a decision to allow AF to continue without further efforts to restore sinus rhythm;
* Heart failure of New-York Heart Association \[NYHA\] class IV or recent unstable NYHA class III.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Buenos Aires, , Argentina
Sanofi-Aventis Administrative Office
Macquarie Park, , Australia
Sanofi-Aventis Administrative Office
Vienna, , Austria
Sanofi-Aventis Administrative Office
Diegem, , Belgium
Sanofi-Aventis Administrative Office
São Paulo, , Brazil
Sanofi-Aventis Administrative Office
Sofia, , Bulgaria
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Providencia Santiago, , Chile
Sanofi-Aventis Administrative Office
Prague, , Czechia
Sanofi-Aventis Administrative Office
Hørsholm, , Denmark
Sanofi-Aventis Administrative Office
Helsinki, , Finland
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Frankfurt, , Germany
Sanofi-Aventis Administrative Office
Kallithea, , Greece
Sanofi-Aventis Administrative Office
Hong Kong, , Hong Kong
Sanofi-Aventis Administrative Office
Budapest, , Hungary
Sanofi-Aventis Administrative Office
Netanya, , Israel
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
Kuala Lumpur, , Malaysia
Sanofi-Aventis Administrative Office
Col. Coyoacan, , Mexico
Sanofi-Aventis Administrative Office
Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Auckland, , New Zealand
Sanofi-Aventis Administrative Office
Lysaker, , Norway
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Bucharest, , Romania
Sanofi-Aventis Administrative Office
Moscow, , Russia
Sanofi-Aventis Administrative Office
Singapore, , Singapore
Sanofi-Aventis Administrative Office
Bratislava, , Slovakia
Sanofi-Aventis Administrative Office
Gauteng, , South Africa
Sanofi-Aventis Administrative Office
Seoul, , South Korea
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Sanofi-Aventis Administrative Office
Geneva, , Switzerland
Sanofi-Aventis Administrative Office
Taipei, , Taiwan
Sanofi-Aventis Administrative Office
Kiev, , Ukraine
Sanofi-Aventis Administrative Office
Guildford Surrey, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum A, Blomstrom P, Borggrefe M, Budaj A, Chen SA, Ching CK, Commerford P, Dans A, Davy JM, Delacretaz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosillo A, Granger CB, Heidbuchel H, Kautzner J, Kim JS, Lanas F, Lewis BS, Merino JL, Morillo C, Murin J, Narasimhan C, Paolasso E, Parkhomenko A, Peters NS, Sim KH, Stiles MK, Tanomsup S, Toivonen L, Tomcsanyi J, Torp-Pedersen C, Tse HF, Vardas P, Vinereanu D, Xavier D, Zhu J, Zhu JR, Baret-Cormel L, Weinling E, Staiger C, Yusuf S, Chrolavicius S, Afzal R, Hohnloser SH; PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268-76. doi: 10.1056/NEJMoa1109867. Epub 2011 Nov 14.
Hohnloser SH, Halperin JL, Camm AJ, Gao P, Radzik D, Connolly SJ; PALLAS investigators. Interaction between digoxin and dronedarone in the PALLAS trial. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1019-25. doi: 10.1161/CIRCEP.114.002046. Epub 2014 Nov 6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-019791-73
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1116-5566
Identifier Type: OTHER
Identifier Source: secondary_id
EFC11405
Identifier Type: -
Identifier Source: org_study_id