SWICFT Institute of Southwest Florida

Concerned about your
Atrial Fibrillation?

Atrial Fibrillation (AF) is the most common abnormal heart rhythm and becomes more frequent with age.  AF can stay constant or come and go. When you have AF, you are at risk of developing blood clots in your heart that may become lodged in an artery in your body. Clots that travel to the brain can cause a stroke. Unfortunately, we know that over 15% of all strokes occur in people with atrial fibrillation. However, we also know that treatment with anticoagulation medications can reduce the risk of stroke by 65%.

Traditional oral anticoagulants (blood thinners), such as warfarin, have been the drug of choice for treating AF for over 60 years. Unfortunately, warfarin’s effectiveness can be dramatically influenced by other medications and certain foods. As a result, we are studying a new investigational drug to treat AF that is not affected by diet or many medications in a study called the ENGAGE AF- TIMI 48 trial. You may want to consider enrolling in the study after reading the answers to some commonly asked questions among patients diagnosed with atrial fibrillation. 

What causes a blood clot to form in the heart?

Normal Heart Function

The heart has four chambers, two upper chambers called atria and two lower chambers called ventricles. An electrical signal generated by a single area in the right atria is conducted through the entire heart, enabling the chambers work together to create a normal heart beat. Each heart beat delivers blood to the body so that it functions normally. When the heart is beating normally, the blood passes freely from the upper chambers to the lower chambers and then to the arteries without forming clots.

Heart Function During Atrial Fibrillation

During atrial fibrillation, there are multiple, irregular electrical signals generated in the atria. As a result, all the chambers of the heart do not contract together in a coordinate manner leading to an irregular heart beat. The two smaller upper chambers of the heart ‘quiver’ instead of beating effectively. This can lead to the formation of blood clots because the blood is not flowing freely in and out of the atria while they are quivering (fibrillating). These clots can travel from the heart and lodge in different arteries of the body, most frequently the brain, which can cause a stroke. Clots that lodge in other arteries can also cause serious health complications.

How are blood clots prevented?

The risk of having a blood clot is reduced by taking a medicine called an anticoagulant or blood thinner. Not everyone can take these blood thinners due to an increased risk of bleeding, often times very serious. Because of this potentially serious side effect, you have to have a frequent blood test to measure how well your blood is clotting. In addition, you must avoid certain foods, alcohol and dietary supplements. DU-176b, the drug we are studying in ENGAGE AF-TIMI 48, may help prevent clots without the need for changing dietary habits.

How is atrial fibrillation treated?

The treatment of atrial fibrillation includes:

1) Reversing the factors that cause atrial fibrillation (controlling high blood pressure and congestive heart failure, treating diseases of the heart and lungs that can cause AF, stopping the use of stimulant drugs such as excessive alcohol intake, and treating hyperthyroidism)

2) Slowing the heart rate with medications such as beta-blockers or calcium blockers

3) Preventing strokes with anti-coagulant medication (blood thinners)

4) Converting atrial fibrillation to a normal heart rhythm with medications or electricity

5) Preventing the recurrence of atrial fibrillation with medications

6) Using procedures (e.g., pacemakers, catheter ablations, surgery) to prevent episodes of AF

What happens to my treatment if I participate in this trial?

If you are an appropriate candidate and agree to participate in this trial you will be assigned, by chance, to receive either 1 of 2 DU-176b dose regimens or warfarin (brand name “coumadin”). Warfarin is the most common blood thinner used for treating atrial fibrillation, and is given in tablet form once daily. The study drug also is an oral tablet taken once each day and is provided at no cost to you. All other medical treatment (medication and procedures) will be decided by your doctors depending on your individual requirements and situation.

On average, patients will take part in this study for about 2 years, but your participation may last 3 - 4 years depending on how quickly the trial enrolls. During this time, we will ask you to return for follow up visits after 8 days, 15 days, 29 days, and every month for the entire duration of the trial. You will make at least 27 follow-up visits, depending on how long you take part in the study. The majority of follow up visits will take about 30 minutes to complete. A few of the visits will take up to 90 minutes to complete. Examples of what will be completed at the study visits are: blood samples, electrocardiogram (ECG), medical history and vital signs.

During your time in the study, you will continue to see your regular doctors.

Interested in Learning More?

If you would be interested in learning more about the ENGAGE AF-TIMI 48 study, or to find out if you are a potential candidate, please either fill out the form below or call (239) 261-2000 and ask for Lori Leo. RN.  Thank you for considering participation in this important research, and we hope to hear from you soon.