Status:
TERMINATED
Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
Lead Sponsor:
Sanofi
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
Primary Objective: * Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned...
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
3236 Patients enrolled
Trial Details
Trial ID
NCT01151137
Start Date
July 1 2010
End Date
September 1 2011
Last Update
October 26 2012
Active Locations (37)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
4
Sanofi-Aventis Administrative Office
Vienna, Austria