StrokeSurvivorBlog

Steve was just enrolled into a Phase III clinical trial being conducted by Bristol-Myers Squibb. This research study Protocol CV185030 (a.k.a. the Aristotle study) is for adults with atrial fibrillation or flutter and are at risk for having a stroke. The purpose of this clinical trial is to determine the safety and effectiveness of an investigational medication (Apixaban) compared to warfarin (Coumadin) in the prevention of stroke or blood clots in approximately 15,000 adults.

About 800 sites in North and South America, Europe, Australia and Asia will be conducting this study.

Most participants will be enrolled for about 3 years. During the first month, there will be 6 study visits. After that, the study visits will occur monthly for the duration of the study.

The clinical trial study will be conducted in 2 parts:

Part 1 – Study Treatment

Participants will be randomly divided into 2 groups. One group will be assigned to take the investigational medication (Apixaban), and the other will be assigned to take warfarin (Coumadin).

This study will be conducted “double-blind.” This means that neither we nor our study doctor will know if Steve is taking the Apixaban or warfarin, except in a medical emergency.

In addition to the study medication, everyone will also take a placebo (inactive pill).

Part 2 – Follow Up

All participants will be contacted by telephone and asked questions regarding side effects or any other significant medical occurrences such as stroke, blood clots, heart attack, or bleeding episodes.

Eligibility

You may be eligible if you:

• Are 18 years or older
• Have atrial fibrillation or flutter
• Have 1 or more of the following:
  • 75 years of age or older
  • Prior stroke, mini stroke, or blood clots
  • Heart failure
  • Diabetes
  • High blood pressure
• Are not at increased risk for bleeding
• Are not currently being treated with blood thinning medication for a condition other than atrial fibrillation
• Do not have uncontrolled high blood pressure