IRB Number:

1692-05

Trial status:

Open for Enrollment

Phase: III

Why is this study being done?

This study is being done to test the effects of an investigational medicine in patients with Atrial Fibrillation/Atrial Flutter. The study will see if this medication can prevent death or cardiovascular hospitalization. The study will also test the safety and tolerability of the medication.

Who is eligible to participate?

1. Participants must have documented atrial fibrillation/flutter within the last 6 months.
   
2. Participants must have at least one of the following:
   
   
   
   • hypertension
   
   
   • diabetes
   
   
   • prior stroke of TIA (mini-stroke)
   
   
   • certain abnormal findings from a 2D-Echocardiography test
   
   
3. OR Patients 75 years of age or older are eligible with or without additaional risk factors.

What is involved?

This study is a randomized trial in which participants will be put into one of two groups by chance (as in flip of a coin). One group will receive a placebo (an inactive pill). The other group will receive the medicine being studied. Both groups will also receive usual standard of care.

During the study, patients will be required to come in to the office for twelve study visits. These visits will include lab tests, ECG's and physical exams. Patients will need to take all of their medications as directed by the study doctor.

How long is the study?

The study will last for about two years.

Who can I contact for additional information?

Beverly Pyle, RN (study coordinator)
Phone: (480) 301-6104

Where is the trial located?

• Scottsdale and Phoenix, AZ
• Phoenix,

Last updated: 03/09/2009