What is the ROCKET AF Study?

ROCKET AF is a clinical research study of a new investigational medication. The study will determine whether the investigational medication is as good as warfarin in reducing the formation of blood clots in patients with atrial fibrillation.

Why carry out research into new blood thinning medications?

While warfarin is very effective at reducing the risk of blood clot formation, doctors are undertaking clinical research to try to develop other, more convenient treatments for patients.

Who can take part?

This clinical research study is for adults 18 years and older who have been diagnosed with atrial fibrillation (a type of irregular heartbeat) and who need treatment with blood-thinning medication because of an increased risk of blot clotting.

What is involved?

The study team will explain to you in detail the role of a study participant. It is their responsibility to answer any questions you may have.

What happens if I change my mind?

Participation in clinical trials, including the ROCKET AF Study, is entirely voluntary and you may withdraw at any time. If you decide you do not want to take part, or you participate but later withdraw, this will not affect the standard of care to which you would otherwise be entitled.

How do I find out if I can participate?

Click here to answer a short series of questions to help us determine whether you may qualify to participate in the study.

If it is determined that you may be eligible to participate, you will be asked to provide contact information. Answering the questions and/or submitting contact information on this website does not obligate you to participate in the study.

Should I talk with my doctor about the study?

Yes! If you are unsure about participating, discuss it with your doctor.

Will completing this survey guarantee my participation in the study?

No. Only the physician at the study site can determine if you are medically qualified to participate in the study. What you can do today is answer several questions about your health and medical history to determine if you pre-qualify for the study.

What is the name of the new investigational drug?

Due to confidentiality requirements, we are unable to provide you with that information at this time.

Are there any side effects to the study treatment?

We are unable to answer medical questions. If you get referred to a study site, they will be happy to review that information with you.

Are you the sponsoring company?

No. We are an independent company working for the drug sponsor, and we are coordinating the research and handling web inquiries about the ROCKET AF Study.

Where are the clinical study sites?

There are a number of study sites located throughout the United States and Canada. If you pre-qualify, we can use your zip code to determine whether there is a ROCKET AF study site in your area currently enrolling patients.

Is there a placebo?

Yes, both treatments groups in this study will take placebo. However, both groups will also be taking anti-coagulant medication; either warfarin (Coumadin^®) or the investigational blood-thinning medication. Participants taking warfarin will also receive placebo pills identical to the study investigational medication and participants receiving the investigational medication will also receive placebo pills identical to warfarin. This is necessary because the study design is double-blind; that means that neither you nor the study doctor will know which treatment group you have been assigned— this is determined at random by a computer. The placebo in each group is necessary to maintain the double-blind nature of the study, because it was not possible to manufacture the treatments being compared to look identical. The placebo pills will not contain any active medication.

What are the risks for participating in this study?

All drugs may cause side effects, so there may be side effects associated with the medications given in this study. Moreover, there is no guarantee that you will benefit by taking part. If you pre-qualify for this study based on your answers to the screener on this web site, the staff at the site where you would receive care will discuss the risks and benefits in detail with you.

Is this drug FDA approved?

To date, the study drug has undergone Phase I and Phase II trials. This means it has been tested for safety in healthy volunteers and for safety and effectiveness in people needing therapy to reduce the risk of blood clotting. The drug is now under evaluation in this Phase III study involving patients with atrial fibrillation and a number of volunteers have already been recruited. Upon completion, results from the Phase III studies will be submitted to the FDA, as part of the application for approval of the drug.

What phase of research is the ROCKET AF study?

This is a Phase III study.

Why is the study called ROCKET AF?

The study has been named ROCKET AF to give doctors, nurses and patients an easier way to refer to the study, because the full medical title is very long. The individual letters R, O, C, K, E, T, A and F represent the first letters of some of the words making up that full title.