ENGAGE AF- TIMI-48 (Atrial Fibrilliation)

Title: ENGAGE AF - TIMI 48

STATUS: In follow-up

Study Sponsor: Daiichi Sankyo

Principal Investigator: Adrian Almquist, MD

Study Synopsis: What is Atrial Fibrillation?  During atrial fibrillation (AF), the heart beats irregularly. This can occur occasionally or all the time. As a result, blood is not pumped completely out of the heart and can collect and form a clot. If a blood clot is pumped from the heart it can become trapped in an artery anywhere in the body. When this happens in an artery in the brain, a stroke occurs. Taking blood thinning medication may prevent blood clots from forming and reduce the chance of having a stroke.

Study Overview:  If you have a history of Atrial Fibrillation, you may be eligible to participate in a worldwide research study that plans to include around 16,500 people across approximately 46 countries. The purpose of this study is to compare an investigational blood thinning medication to one that is already on the market. Study participants will receive study-related medical care and study medication at no cost.

Who is eligible for this research study? You may qualify if you:*

• Are at least 21 years old
• Have a history of Atrial Fibrillation

* There are additional entry requirements for this study that the research site will discuss with you.

What can I expect if I am able to participate?

·       Provide written informed consent - Informed consent is a document that provides study information and gives the possible risks and benefits of participating in the study. Your participation in this study would be voluntary.

• Review and discuss your medical history
• Visit the study center about every month over a period of up to 2 years
• Take study medication as directed
• Receive study-related medical care and study medication at no cost

What is a research study?  A clinical research study is used to determine whether new investigational drugs or treatments are both safe and effective. Carefully conducted clinical research studies are a way to find treatments that will work for people in the future.

Why participate in a research study?  Participants in research studies can learn more about their own condition and about research treatments before they are widely available. They also help others by contributing to medical research.

What are the possible benefits, risks, and side effects of an investigational medication?  With all investigational medications, there are possible benefits, risks, and side effects that the research site will discuss with you.

Has this research medication been tested on people before?  Yes, the investigational medication that you may receive has already been tested in some people in other studies.

Who do I contact for more information?  Karen Meyer, RN at 612.863.5855 or email karen.meyer2@allina.com.