Status:
This study is ongoing, but not recruiting participants.
Purpose:
The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.
Interventions:
Apixaban
is a compound being investigated as an anticoagulant. It acts by inhibiting coagulation factor Xa.
|
Warfarin
Anticoagulant (Vitamin K antagonist)
|
Location(s):
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
Year Started:
2006
Design:
Interventional, Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study.
Inclusion Criteria
Males and females ≥ 18 yrs with AF and one or more of the following risk factors for stroke:
Age ≥ 75, previous stroke, TIA or Systemic Embolism, symptomatic congestive heart failure or left ventricular dysfunction with LVEF ≤ 40%, diabetes mellitus or hypertension requiring pharmacological treatment.
Patient Involvement:
Subjects will be randomized to one of two arms:
1: Active Comparator Drug: warfarin
Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0) or 2: Experimental Drug: apixaban
Oral tablets, 5.0 mg, twice daily.
Primary Outcome:
Confirmed stroke or systemic embolism.
Secondary Outcome:
Confirmed ischemic stroke, hemorrhagic stroke, systemic embolism, all cause death.
|
Source of Information:
ClinicalTrials.gov
|
Web Links and Publications:
|
Trials
Directories