The ARISTOTLE trial was conducted to test the drug Apixaban and its effects on atrial fibrilation. It was one of the largest ever undertaken be medical professionals. ARISTOTLE, or Apixaban for Reduction In Stoke and Other ThromboemboLic Events, tested over 18,000 individuals in 39 countries at 1,000 medical centers. The test itself was designed to provide results for groups of people at high risk for stroke that had at least one other additional risk factor.
The average of the participants was 70 years of age. Over 30% were older than 75 years. Almost 25% of the participants had diabetes. 87% had been diagnosed with high blood pressure and 28% with various forms of heart failure or damage. Almost 20% had suffered a previous stroke.
Patients who have suffered a stroke or are being treated for other cardiovascular related conditions are normally put on an anticoagulant as part of their treatment plan. Anticoagulants work to thin the blood so that the heart does not have to work so hard to pump it through the body. They also change the viscosity of the blood so that blood cells do not adhere to each other or the walls of the blood vessels. When red blood cells stick together, they form clots. A clot can block a blood vessel to the brain causing a stroke or the heart causing a heart attack.
The trial was held to determine the effectiveness of Apixaban over Warfarin. The participants were monitored for over a year and a half to make sure any type of fluctuation in lifestyle was experienced. The test was of a double blind, double-dummy design.
Patients at random were administered either an dosage-adusted warfarin medication or 5mg of apixaban two times a day. During the course of the clinical trial, it was found that apixaban was able to reduce major types of bleeding by almost 31%. The risk of systemic embolism and stroke were reduced over 20%, while overall mortality was reduced by over 10%.
As the population ages, it is apparent that the risk of strokes and embolisms increase drastically as people get older. Atrial fibrillation is a strong indicator of heart disease and is present in many patients who are at risk of having a stroke. Finding a more efficient way to treat heart and cardiovascular disease that results in less side effects, helps to improve the quality of life of the senior population.
The results of the ARISTOTLE clinical trial were reported at a meeting of the European Society of Cardiologists being held in Paris, France. One of the leading researchers, Dr. Christopher Granger gave submitted the results. A few months later, a professer from the University of Alberts, Dr. Justin Ezekowitz presented the findings to the Canadian Cardiovascular Congress. He explained that the use of Apixaban was a much better treatment than Warfarin.