EUCTR2006-002147-91-IT进行中（未招募）不适用
Protocol Title: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind,Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Strokeand Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation - ARISTOTLE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •For entry into the study, the following criteria MUST be met.
- •1) Age ≥ 18 years
- •2) Permanent or persistent atrial fibrillation or atrial flutter documented by ECG at the
- •time of enrollment.
- •If not in atrial fibrillation/flutter at the time of enrollment, must have atrial
- •fibrillation/flutter documented on two separate occasions at least 2 weeks apart in the 6
- •months prior to enrollment. Atrial fibrillation/flutter may be documented by ECG, or as
- •an episode at least one minute in duration on a rhythm strip or Holter recording.
- •3) One or more of the following risk factor(s) for stroke:
- •a) Age 75 years or older
- •b) Prior stroke, TIA or systemic embolus
- •c) Either symptomatic congestive heart failure within 3 months or left ventricular
- •dysfunction with an LV ejection fraction (LVEF) ≤ 40% by echocardiography,
- •radionuclide study or contrast angiography
- •d) Diabetes mellitus
- •e) Hypertension requiring pharmacological treatment
- •4) Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception to avoid pregnancy throughout the treatment period of the study or for
- •2 weeks after the last dose of study medication, whichever is longer, in such a manner
- •that the risk of pregnancy is minimized.
- •WOCBP include any female who has experienced menarche and who has not undergone
- •successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral
- •oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive
- •months; or women on hormone replacement therapy [HRT] with documented serum
- •follicle stimulating hormone [FSH] level > 35 mIU/mL). Even women who are using oral
- •contraceptives, other hormonal contraceptives (vaginal products, skin patches, or
- •implanted or injectable products), or mechanical products such as an intrauterine device
- •or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be
- •considered to be of childbearing potential.
- •WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25
- •IU/L or equivalent units of HCG) within 48 hours prior to the start of investigational
- •5) All subjects must provide signed written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)
- •2) Clinically significant (moderate or severe) mitral stenosis
- •3) Increased bleeding risk that is believed to be a contraindication to oral anticoagulation
- •(e.g. documented peptic ulcer disease within 6 months, previous intracranial
- •hemorrhage)
- •4) Conditions other than atrial fibrillation that require chronic anticoagulation (e.g.
- •prosthetic mechanical heart valve)
- •5) Persistent, uncontrolled hypertension (systolic BP > 180 mm Hg, or diastolic BP
- •> 100 mm Hg)
- •6) Active infective endocarditis
- •7) Planned major surgery
- •8) Planned atrial fibrillation or flutter ablation procedure
- •9) Use of an unapproved, investigational drug or device within the past 30 days
- •10) Required treatment with aspirin > 165 mg/day
- •11) Simultaneous treatment with both aspirin and a thienopyridine (e.g., clopidogrel,ticlopidine)
- •12) Severe comorbid condition with life expectancy of ≤ 1 year
- •13) Active alcohol or drug abuse, or psychosocial reasons that make study participation impractical
- •14) Recent stroke (within 30 days)
- •15) Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 25 mL/min, See Section 6.3.2.2)
- •16) ALT or AST > 2X ULN or a Total Bilirubin ≥ 1.5X ULN (unless an alternative causative factor [e.g., Gilbert?s syndrome] is identified)
- •17) Platelet count ≤ 100,000/ mm3
- •18) Hemoglobin < 10 g/dL
- •19) Inability to comply with INR monitoring
- •20) Prior randomization into an apixaban clinical study
- •21) Prisoners or subjects who are involuntarily incarcerated
- •22) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- •23) Women of child bearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy:
- •a) WOCBP using a prohibited contraceptive method
- •b) WOCBP include any female who has experienced menarche and who has not
- •undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,
- •or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥ 12
- •consecutive months; or women on hormone replacement therapy (HRT) with
- •documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. Even
- •women who are using oral contraceptives, other hormonal contraceptives (vaginal
- •products, skin patches, or implanted or injectable products), or mechanical
- •products such as an intrauterine device or barrier methods (diaphragm, condoms,
- •spermicides) to prevent pregnancy, or are practicing abstinence or where their
- •partner is sterile (e.g., vasectomy) should be considered to be of child bearing potential
- •c) Women who are pregnant or breastfeeding
- •d) Women with a positive pregnancy test on enrollment or prior to administration of
- •investigational product.
- •Eligibility criteria for this study have been carefully considered to ensure the safety of the
- •study subjects and the integrity of the study data. It is imperative that subjects fully meet
- •all eligibility criteria.
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