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 - Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy (PALLAS)

Phase 1

• Conditions: Atrial Fibrillation; MedDRA version: 14.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2010-019791-73-BE
• Lead Sponsor: Sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-30
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10800

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
Patients aged 65 years or older with 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 less or equal to 0.40
- Peripheral arterial occlusive disease
- Aged 75 years or older with both hypertension and diabetes mellitus
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified