- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01151137
Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS)
A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400mg BID on Top of Standard Therapy in Patients With Permanent Atrial Fibrillation and Additional Risk Factors
Primary Objective:
- 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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study period per participant was variable depending on the enrollment in the study.
A final follow-up visit had to occur within 1 month after the CSED.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
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
-
-
-
-
-
Sao 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
-
-
-
-
-
Praha, Czech Republic
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Horsholm, 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
-
-
-
-
-
Natanya, Israel
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Milan, Italy
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Seoul, Korea, Republic of
- 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
-
-
-
-
-
Bucuresti, Romania
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Moscow, Russian Federation
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Singapore, Singapore
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Bratislava, Slovakia
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Gauteng, South Africa
- 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
- Sanofi-Aventis Administrative Office
-
-
-
-
New Jersey
-
Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
Permanent AF defined by the presence of all of the following 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:
- Paroxysmal AF;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dronedarone
Dronedarone 400 mg twice a day until the CSED
|
Film-coated tablet Oral administration under fed conditions (during breakfast and dinner)
Other Names:
|
Placebo Comparator: placebo
Placebo (for Dronedarone) twice a day until the CSED
|
film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overview of the Two Co-primary Outcomes
Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions [MI], or cardiovascular death. Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause. Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks [TIA], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause. |
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
Time to First Co-primary Outcome (Cumulative Incidence Function)
Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation. |
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
Time to Second Co-primary Outcome (Cumulative Incidence Function)
Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation. |
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Deaths
Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
Deaths were classified according to the primary cause of death.
|
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
Time to Cardiovascular Death (Cumulative Incidence Function)
Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
Time to cardiovascular death was defined as the time from randomization to the death. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation. |
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overview of Cardiovascular Events
Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)
|
|
Overview of Adverse Events [AE]
Time Frame: from first study drug intake up to 10 days after the last study drug intake
|
AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
|
from first study drug intake up to 10 days after the last study drug intake
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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. Erratum In: N Engl J Med. 2012 Feb 16;366(7):672.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC11405
- 2010-019791-73 (EudraCT Number)
- U1111-1116-5566 (Other Identifier: UTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on Dronedarone
-
Rabin Medical CenterUnknownICD | ICD SHOCKS | DRONEDARONE
-
SanofiTerminatedAtrial FibrillationUnited States, Canada
-
SanofiTerminatedAtrial FibrillationCanada
-
SanofiCompletedAtrial Fibrillation | Atrial FlutterUnited States, Canada, Argentina, South Africa, Australia
-
SanofiTerminatedCongestive Heart FailurePoland, Netherlands, Sweden, Denmark, Hungary, Norway
-
SanofiCompletedAtrial FibrillationFrance, Poland, Italy, Netherlands, Spain, Sweden, Switzerland, Belgium, Czech Republic
-
University of UtahSanofiCompletedAtrial Fibrillation
-
SanofiCompleted
-
SanofiCompletedAtrial Fibrillation | Atrial FlutterFrance, Poland, Germany, Italy, Netherlands, Spain, Belgium, Czech Republic, United Kingdom, Denmark, Finland, Hungary
-
SanofiCompletedAtrial Fibrillation | Atrial FlutterUnited States, Canada, Poland, Russian Federation, Germany, Italy, Netherlands, Portugal, Spain, Sweden, Turkey, India, Malaysia, Philippines, Singapore, Taiwan, Belgium, Czech Republic, Mexico, Tunisia, Argentina, Finland, Hungary, I... and more