Therapeutic Areas
Atrial Fibrillation
Atrial Fibrillation is a common cardiac (heart) problem, and it increases the chance of having a stroke. It affects more than 2.5 million people in the U.S. and risk of developing it increases with age. Current standard treatment can be challenging and time-consuming.
The primary purpose of this study is to determine if Drug X is as effective as the current standard treatment (i.e., dose-adjusted warfarin) in preventing strokes and embolisms in patients with atrial fibrillation.
The basic inclusion criteria are as follows:
- Male or female subjects, 18 years and older, who have a documented diagnosis of non-valvular atrial fibrillation; and
- History of prior ischemic stroke, transient ischemic attack (TIA), or non-CNS systemic embolism believed to be cardio embolic in origin OR has 2 or more of the following risk factors: (1) heart failure and/or left ventricular ejection fraction ≤ 35%, (2) hypertension, (3) diabetes mellitus, (4) age ≥ 75 year.
Treatment on the study lasts for 1 year, plus up to 1 year for safety follow-up.
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