An Open-label Randomized Controlled Multimeter Study Exploring Two Treatment
Brief Description Of Study
The purpose of the study is to determine if rivaroxaban or Vitamin K Antagonist (VKA)in combination with other antiplatelet therapies is safe to use in men and women over age 18 with atrial fibrillation who also receive heart artery stents. The experimental drug used in this study is called rivaroxaban, a newer blood thinner that is approved for use to reduce the formation of blood clots. Rivaroxaban is a drug that is being tested in this study to see if it may be useful in treating patients who have an irregular heart rhythm beat (called atrial fibrillation(AF))and have had a percutaneous coronary intervention (PCI) (a medical term for injecting dye in your heart arteries without surgery) and required the placement of a stent in at least one of your heart arteries. This study will compare the effects (both good and bad) of rivaroxaban to those of a vitamin K antagonist (VKA). VKAs are an older class of blood thinner already used to treat the prevention of clot formation in subjects with atrial fibrillation and in patients with PCI. Rivaroxaban and VKA act as blood thinners to reduce the formation of blood clots inside the heart artery. Some VKA blood thinners are called warfarin (Coumadin), fluindione, phenprocoumon, acenocoumarol, apixaban and other names. Patients will be placed into a treatment group randomly. There are 3 treatment groups in this study: the rivaroxaban 15 mg group the rivaroxaban 2.5 mg group the VKA group The study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. The total duration of participation in the study for each subject is about 12 months and will include about 9 visits to the study doctor. Study tests, procedures and clinic visits are shown on Study Schedule of Procedures table attached to this application. This is not an event-driven study, but primarily a hypothesis-generating exploratory study to gather bleeding data on 3 anticoagulant management strategies after PCI in subjects who have paroxysmal, persistent, or permanent non-valvular AF. Reliable estimates of bleeding rates in the AF patient population following PCI procedures are generally not available. Although combination therapy with ASA, clopidogrel, and warfarin has been recommended in consensus treatment guidelines, this recommendation represents expert opinions rather than conclusions obtained from prospectively conducted study data.