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Clinical Studies

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  • A Prospective, Randomized, Open-Label Blinded Endpont Evaluation (PROBE) Parallel Group Study Comparing Edoxaban (DU-176b) With Enoxaparin/Warfarin Followed by Warfarin Alone in Subjects Undergoing Planned Electrical Cardioversion of Nonvalvular Atrial Fibrillation Rochester, Minn.

    The purpose of this study is to compare edoxaban (investigational drug) with warfarin and enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot complications in subjects with atrial fibrillation whose doctors plan to treat them with an electrical cardioversion. It is expected that 284 sites will recruit 2200 subjects from North America, EU, Russia, Ukraine and Israel. Participants will be randomly allocated to receive either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if required. Participants will have an equal chance of receiving either treatment. Participants will be in the study for a maximum of 82 days. Study procedures will include physical examinations, vital signs (pulse and sitting blood pressure), ECG (electrocardiogram), finger prick blood clotting tests, blood samples, urine samples and completion of Quality of Life questionnaires. The study is expected to show that edoxaban will provide comparable incidence rates for efficacy to warfarin plus enoxaparin, the current standard treatment, and will be at least as safe as warfarin for the incidence rate for bleeding
  • Clinical Determinants and Outcome of Patients with New-onset Atrial Fibrillation and Flutter Following Cardiac Surgery Rochester, Minn.

    The aims of this investigation are:

    To assess the predictive value (and accuracy) of clinical and physiologic preoperative variables in identifying patients at risk for the development of new-onset atrial arrhythmia after cardiac surgery.

    To assess the feasibility of a physiological risk model based on clinical and echocardiographic indexes to predict post-operative AF.

    To assess the role of prophylactic agents in the prevention of new-onset postoperative POAF

    To assess the economic impact of new-onset postoperative AF:

    • Length of hospital stay (will be measured as fractions of days)

    • Hospital cost (will be measured in standardized dollars)

    • Resource utilization (will be measured by resource-based relative-value units)

    To assess the outcome of patients who develop early atrial fibrillation following cardiac surgery:

    • To assess whether first time new-onset POAF predicts long-term AF.

    • Examine the predictive value of potential preoperative variables in identifying patients at risk of developing
  • Strain Imaging to Predict Recovery of Left Ventricular Systolic Function and Atrial Fibrillation Recurrence after Restoration of Sinus Rhythm in Patients with Atrial Fibrillation? Rochester, Minn.

    The objectives of this study are: (1) to analyze beat-to-beat variability and the variations of R-R interval to pre-preceding R-R interval (RRp/RRpp) ratio of left ventricular (LV) function by strain imaging (2D speckle tracking echocardiography) in patients with atrial fibrillation (AF) undergoing electrical cardioversion(ECV) or radiofrequency catheter ablation (RFCA) as a predictor of a recovery of LV function and volume after restoration of sinus rhythm , (2) to evaluate left atrial mechanics as a predictor of for AF recurrence after electrical cardioversion (ECV) or radiofrequency catheter ablation (RFCA)
  • The Role of Autoimmune Mechanisms in the Pathogenesis of Atrial Fibrillation Rochester, Minn.

    This research study is being done to find out whether autoimmune mechanisms are associated with the development of atrial fibrillation.
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