< clinical trials / Rocket AF
Clinical Trial Name:
Rivaroxaban Once Daily Oral Direct factor Xa Inhibition Compared with Vitamin K antagonist for Prevention of Stroke and Embolism Trial in Atrial Fibrillation

Status: enrolling

FDA Clinical Trial number:
The study drug, rivaroxaban, has undergone Phase I and Phase II trials for safety and effectiveness in people needing therapy to reduce the risk of blood clotting. This study drug is now under evaluation in this Phase III study involving patients with atrial fibrillation.  Upon completion, the results from this phase III trial will be submitted to the FDA as part of the application for approval of the drug. .

Brief description:  
Phase III, efficacy and safety trial of Rivaroxaban for the prevention of stroke and embolism in subjects with non-valvular atrial fibrillation

Eligibility:  
Subjects 18 years and older who have been diagnosed with atrial fibrillation (irregular heartbeat) and who need treatment with blood-thinning medication because of an increased risk of blot clotting.

Inclusion/exclusion criteria:
Diagnosis of afib with prior evidence of stroke, transient ischemic attack or other type of blood clot originating in the heart;  OR history of three or more of the following risk factors:  age >=75 years;  high blood pressure;  heart failure signs and symptoms; diabetes mellitus.  

Sponsor(s):
co-developed under a collaboration and license agreement between Bayer HealthCare AG and Ortho McNeil Pharmaceuticals