Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation ARISTOTLE
- Conditions
- -I48 Atrial fibrillation and flutterAtrial fibrillation and flutterI48
- Registration Number
- PER-099-08
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Age> 18 years
• In atrial fibrillation or atrial flutter not due to reversible cause and documented by ECG at the time of enrollment
• One or more of the following risk factors for stroke: Age 75 years of age or older, stroke, TIA or previous systemic embolism, c) Symptomatic congestive heart failure within 3 months or left ventricular dysfunction with a fraction of LV ejection (LVEF) <40% as measured by echocardiography, study with radionucleotides or contrast angiography, Diabetes mellitus, Hypertension requiring pharmacological treatment
• Women of childbearing age should use adequate contraception to avoid pregnancy during the study treatment period or for 2 weeks after the last dose of study medication, whichever is longer, in order to minimize the risk of pregnancy .
• All subjects must provide signed written informed consent.
• Fibrillation or atrial flutter due to reversible causes (eg thyrotoxicosis, pericarditis)
• Clinically significant mitral stenosis (moderate or severe)
• Risk of increased bleeding believed to be a contraindication to oral anticoagulation (eg, previous intracranial hemorrhage)
• Conditions other than atrial fibrillation requiring chronic anticoagulation (eg mechanical prosthetic heart valve)
• Persistent uncontrolled hypertension (systolic BP> 180 mmHg, or diastolic BP> 100 mmHg)
• Active infectious endocarditis
• Major surgery planning
• Procedure planning for fibrillation or atrial flutter ablation
• Use of a medication or experimental device not approved within the last 30 days
• Requires treatment with> 165 mg / day of aspirin
• Simultaneous treatment with aspirin and a thienopyridine (eg clopidogrel, ticlopidine)
• Severe comorbid condition with life expectancy <1 year
• Active abuse of alcohol or medication, or psychological reasons that would make participation in the study impractical
• Recent ischemic stroke (within 7 days)
• Severe renal insufficiency (serum creatinine> 2.5 mg / dl or calculated creatinine clearance <25 ml / min
• ALT or AST> 2 x ULN or a total bilirubin> 1.5 x ULN (unless an alternative causative factor is identified [eg, Gilbert´s syndrome])
• Platelet count <100,000 / mm3
• Hemoglobin <9 g / dl
• Inability to comply with INR monitoring
• Prior randomization in a clinical study with apixaban
• Prisoners or subjects with involuntary imprisonment
• Subjects compulsorily detained for the treatment of a psychiatric or physical illness (eg, infectious disease).
• Women of childbearing age unable or unwilling to use an acceptable contraceptive method to avoid pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method