Primary Investigator: Richard Weachter, MD
Study Coordinator: Kathy Belew, CNS-BC
Status: Closed to enrollment; follow-up continues
Study Title: Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double Blind Trial
Purpose: To determine if apixaban 5 mg BID (2.5 mg BID in selected patients) is superior to ASA (81 to 324 mg QD) for preventing the composite outcome of stroke or systemic embolism in patients with atrial fibrillation and at least one additional risk factor for stroke who have failed or are unsuitable for vitamin K antagonist therapy.
AVERROES Optional Follow-Up Study: Long-Term Open-Label Extension (LTOLE)
In addition to the double-blind phase of the study, an optional Long-Term Open-Label Extension (LTOLE) with the investigational study drug, apixaban, will be available to patients in the study once the double-blind phase of the study is completed or the study is terminated early due to superior efficacy of apixaban.
Call Kathy Belew (beeper 573-499-8063) and/or on-call research nurse (on-call beeper 573-499-8084) or Dr. Weachter if subject is admitted to the hospital or for any questions regarding study medication.