Clinical Research Study for People with Atrial Fibrillation (Afib)

The ROCKET-AF Study is seeking volunteers who have an irregular heart beat known as atrial fibrillation, and it is possible that you could qualify to participate. The purpose of the research is to evaluate a new investigational medication for this condition. The study medication is designed to thin the blood to reduce the risk of stroke in people who have been diagnosed with atrial fibrillation.

What is atrial fibrillation?

Atrial fibrillation (Afib) is an arrhythmia, an irregular heartbeat. It is the most common type of arrhythmia and its prevalence increases with age.

What are the symptoms?

Not everyone with Afib has symptoms, but some have an uncomfortable awareness of a rapid or irregular heartbeat, referred to as palpitations. In a normal heart, the heart muscle contracts and expands regularly to pump blood around the body. But in Afib, the heart muscle beats irregularly and more rapidly than is normal. This is why people with Afib sometimes describe a fluttering or quivering feeling in their chest. In Afib, the heart muscle beats irregularly and more rapidly than is normal. Other symptoms are sometimes experienced because of the heart’s diminished ability to effectively pump blood around the body. These include shortness of breath, weakness, fatigue, dizziness, fainting and chest pain.

What are the consequences?

While many of the symptoms of Afib can be distressing and debilitating, one of the more serious consequences of atrial fibrillation is the increased risk of stroke. In a heart that fibrillates (quivers), there is an increased risk of a blood clot forming and travelling to other areas of the body. When it travels to the brain and lodges in a blood vessel, this results in a stroke. Therefore, a vital goal of treating Afib, in addition to restoring a normal heart rhythm, is preventing blood clot formation in the heart.

What can be done to help?

If you or someone close to you has recently been diagnosed with Afib, it is natural to feel anxious and worried. But with the diagnosis comes the reassurance that appropriate treatment can now be prescribed. People with Afib considered at risk are usually treated with a blood-thinning medication to prevent clot formation.

One of the most frequently prescribed blood thinners is warfarin (Coumadin®). While warfarin is a 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. If you have Afib, you might be interested to learn more about a clinical research study now underway to evaluate a new investigational blood-thinning medication. Regardless of whether or not you are already taking warfarin, you could be eligible to take part in this study.

What is this clinical study?

The study now underway will evaluate an investigational new drug for Afib called rivaroxaban. Like warfarin, rivaroxaban acts as a blood thinner. The study will determine whether rivaroxaban is as good as warfarin in reducing the formation of blood clots in the hearts of patients with Afib.

Who can take part? The main eligibility criterion is a diagnosis of Afib. Other entry criteria also need to be met and these will be assessed by the study team (doctors, nurses and sometimes other healthcare personnel).

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. There will be a 50:50 chance of being assigned to receive either the study medication rivaroxaban, or warfarin. If you qualify to take part, you will be required to take your medication as instructed and to attend the clinic for regular appointments to review your progress. Participation in the 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.

Want to know more?

This information has been provided to notify you about a clinical research study taking place at a local clinic. We invite you to find out more and see whether you could qualify to take part. Inquiring does not obligate you to participate in the study. It is your decision. If you do take part, you will be making a contribution to medical science and the treatment of Afib.

KGK Synergize Inc.

T:519-858-8359

www.kgksynergize.com