Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT01151137

Purpose

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

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Dronedarone (SR33589) Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Attack

Drug Information available for: Dronedarone

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Time from randomization to first occurrence among stroke, systemic arterial embolism, myocardial infarction or cardiovascular death [ Time Frame: Follow-up between 3 months (last patient) and 3 years (first patient) ] [ Designated as safety issue: No ]
The follow-up is until the common study end date that is a fixed date that will be set by the Steering Committee during the study.
Time from randomization to first occurrence of unscheduled cardiovascular hospitalization or death from any cause [ Time Frame: Follow-up between 3 months (last patient) and 3 years (first patient) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time from randomization to cardiovascular death [ Time Frame: Follow-up between 3 months (last patient) and 3 years (first patient) ] [ Designated as safety issue: No ]

Enrollment:	3236
Study Start Date:	July 2010
Study Completion Date:	September 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dronedarone SR33589, 400 mg, one tablet twice a day with the morning and evening meals	Drug: Dronedarone (SR33589) Pharmaceutical form:tablet Route of administration: oral
Placebo Comparator: placebo placebo, one tablet twice a day with the morning and evening meals	Drug: placebo Pharmaceutical form:tablet Route of administration: oral

Detailed Description:

All patients are followed until a Common Study End Date that will be anticipated based on the projected blind number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death). The follow-up duration per patient should range between 3 months (last patient) and 3 years (first patient).

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
- Patient and physician decision 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 ≦ 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151137

Show 42 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi-Aventis

More Information

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum Á, Blomström P, Borggrefe M, Budaj A, Chen SA, Ching CK, Commerford P, Dans A, Davy JM, Delacrétaz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosillo A, Granger CB, Heidbüchel 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, Tomcsányi 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. Epub 2011 Nov 14.

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT01151137 History of Changes
Other Study ID Numbers:	EFC11405, 2010-019791-73, U1111-1116-5566
Study First Received:	June 22, 2010
Last Updated:	November 9, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2012