What is the purpose of this trial?

The primary goal of this trial is to determine the effectiveness of a new investigational medication, and to compare it to Coumadin^® (warfarin), at keeping anticoagulation (blood thinning) levels within beneficial range.

Who will participate?

Approximately 600 people at up to 50 sites across the US who require long-term anticoagulation (blood thinning) therapy for one or more of the following conditions will participate:

• Atrial fibrillation
• Heart valve replacement
• History of deep vein thrombosis
• History of heart attack or cardiomyopathy

How will I know whether I'm on the investigational medication or Coumadin^®?

There is a 50/50 chance of being on either. Neither you nor anyone on your clinical team will know which treatment you're receiving. This "not knowing" by participants and their medical team is done in clinical trials to make sure that the trial is conducted fairly. It's important to understand that at no time during this clinical trial will you be without anticoagulation therapy.

When will I know if I'm accepted into this clinical trial?

If you decide to participate, you and your clinical trial doctor (investigator) or nurse will review the informed consent form. Signing the form allows you to enter the screening period during which you'll be given a thorough physical exam along with lab tests. If medically qualified, you'll begin the treatment phase of the trial.

What happens during the treatment phase?

You'll be seen on a regularly scheduled basis by a special team of medical professionals, specifically chosen for their expertise and experience in anticoagulation therapy.

If you're currently taking Coumadin^®, you're already familiar with the need for regular blood tests to monitor your INR (blood clotting) levels. All qualified participants can expect to visit the clinical site more frequently during the first 2 weeks, but when their INR levels are consistently within a beneficial range, clinic visits will be made only biweekly or weekly. (For a better understanding of how INR levels are measured, see Anticoagulation Therapy.)

How long is this clinical trial?

Your participation may last from 6 to 12 months. At the end of your participation, if you qualify medically, you'll be given an opportunity to participate in an extension of this trial in which all eligible participants receive the investigational medication.

How important are the clinic visits?

Your clinic visits are very important, much like your current office visits to monitor your anticoagulation therapy. Everyone conducting this clinical trial appreciates the time and commitment participation involves. Every effort will be made to respect your time and move you through your visits as quickly as possible. Any patient on anticoagulation therapy is best seen routinely to make sure INR levels remain in a safe range.

What happens during site visits?

Your vital signs will be taken and recent medical history discussed. Most of the blood draws will be done by a "finger stick." This test involves a prick to your finger, and from a drop of blood, reveals whether your dosage needs to be raised, lowered, or maintained. This fast, simple test allows you to leave the clinic visit with your next weeks' dosage.

How do I keep my medication and dosing straight?

You'll be given one or more 7-day prefilled pillboxes. You simply take your daily dose each evening and bring the pillbox dispensers back to your next clinic visit to be filled again. It will be important not to change the order of each daily dose. This will be discussed with you at each of your visits.

What do I do to learn more?

Contact your clinical trial team—they'll be glad to answer any questions you may have.

Am I allowed to take aspirin during this trial?

Your clinical trial doctor will talk with you about all of your medications. Some patients can continue to take low-dose aspirin (ie, baby aspirin), but because it also thins blood, in some people this combination could put them in danger of bleeding.

To know whether any medication or vitamin supplement is safe to take during the trial, ask your clinical trial doctor before taking it.

Will I still see my regular doctor if I participate?

You will still see your regular doctor whenever you wish. You'll remain in the care of your personal physician for the duration of the study as clinical trial doctors provide only trial-related care. Your doctor can be notified of your participation and provided with any other information requested if you choose.

Does it cost me anything to participate?

All of your trial-related medication, lab work, evaluations, and ongoing monitoring are provided at no cost to you or your insurance company. Enrolled participants will also be reimbursed for their time and travel.

What if I rely on family members for support?

If someone regularly drives you to your medical appointments, you may want to consult with them to make sure your clinic visits can be accommodated within their schedule.

How will the information for this clinical trial be used?

The information gained from your participation will make a valuable contribution to the future development of this investigational medication. The clinical trial doctor and staff will protect the privacy of your records and your identity within those records. Participants typically are identified by number or initials throughout the trial. Your identity will be kept confidential at all times except where disclosure may be required by law or as otherwise provided in your HIPAA Authorization.

What if I have to withdraw from the clinical trial?

Your participation is voluntary. You can change your mind at any time. There will be no penalty to you and your regular medical care will not change. Simply tell the clinical trial doctor or staff that you are unable to continue and return all unused medications and materials. After you withdraw from the trial, your doctor may return you to your previous treatment. Some additional visits will be necessary and important to ensure that your INR levels are kept within a safe range.