Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
| Status: | Archived |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2010 |
| End Date: | August 2013 |
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
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).
We found this trial at
116
sites
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