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临床试验/EUCTR2006-002147-91-FI
EUCTR2006-002147-91-FI进行中（未招募）不适用

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 + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific, version 3.0, dated 04-Nov-2006Revised protocol 04 incorporating Amendments 02, 05, 07, 10 & 11 and Administrative letters 02, 04, 05 & 08 - ARISTOTLE

Bristol Myers Squibb International Corporation0 个研究点目标入组 18,000 人开始时间: 2007年3月30日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
18,000
研究概览入排标准研究者记录与标识符相似试验

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) In atrial fibrillation or atrial flutter not due to a reversible cause and 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 not due to a reversible cause at least 2 weeks apart in the 12 months prior to enrollment. Atrial fibrillation/flutter may be documented by ECG, or as an episode lasting at least one minute on a rhythm strip or Holter recording or intercardiac electrogram (from an implanted pacemaker or defibrillator).
  • •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 arepracticing 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. 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 ischemic stroke (within 7 days)
  • •15) Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine
  • •clearance < 25 mL/min)
  • •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 < 9 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
  • •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 to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.

研究者

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