PER-099-08已完成未知
A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 0（—）
入选标准
- •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.
排除标准
- •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
研究者
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