EUCTR2007-001557-26-CZ进行中（未招募）1 期
Apixaban Versus Acetylsalicyclic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double Blind Trial+ Pharmacogenetics Blood Sample Amendment 01 (Version 2.0 - dated 22-Jun-2007) and related Administrative Letter dated 09-July-2007+ Effectiveness of Apixaban for Prevention of Embolic Stroke MRI Assessment Amendment Number 02 - Site Specific (Version 2.0 - dated 22-Jun-2007)+ Revised protocol 05 incorporating Amendment 13 dated 24 September2013
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6,160
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
- •1) a) Signed written informed consent form
- •2) Target Population
- •b) Permanent, paroxysmal or persistent atrial fibrillation documented by 12 lead ECG on the day of screening
- •If not in atrial fibrillation at screening, atrial fibrillation must be documented in the
- •6 months prior to enrollment by 12 lead ECG, or as an episode at least 5 minutes in
- •duration on a rhythm strip or Holter recording. Pacemaker or ICD electrogram
- •recordings may be used to document AF but the duration of atrial fibrillation must be
- •at least 30 minutes if this is the only documentation of AF.
- •c) Presence of at least one of the following risk factors for stroke:
- •Prior stroke or TIA
- •Age = 75 years
- •Arterial hypertension on treatment
- •Diabetes mellitus
- •Heart failure. NYHA Class 2 or greater at time of enrollment
- •Left ventricular ejection fraction 35% or less, documented within 6 months of
- •Documented peripheral arterial disease (previous arterial revascularization,
- •limb or foot amputation, or current intermittent claudication with ankle-arm
- •systolic blood pressure ratio < 0.9)
- •d) The patient is not currently receiving vitamin K antagonist therapy for one of
- •the following reasons:
- •- Previous vitamin K antagonist therapy has been demonstrated to be
- •unsuitable and its use has been discontinued (e.g., poor anticoagulant
- •control, adverse events, need for other treatments that may interact
- •with VKA, patient unable or unwilling to adhere to dose or INR
- •monitoring instructions)
- •- Vitamin K antagonist therapy has not been previously used but would
- •be expected to be unsuitable (e.g., unlikely to comply with dosing or
- •monitoring requirement, need for other treatments which may interact
- •with VKA, unlikely to adhere to restrictions on alcohol, diet or nonprescription
- •medications, risk of VKA therapy considered to outweigh
- •the risk of stroke or systemic embolism, patient is unwilling to take
- •3) Age and Sex
- •e) Men and women = 50 years of age
- •LONG TERM OPEN LABEL EXTENSION
- •1) Signed Written Informed
- •a) All subjects must provide signed written informed consent to participate in the
- •Long-Term Open-Label Extension
- •2) Target Population
- •a) All subjects must be receiving double-blind study medication (i.e., not having
- •permanently or temporarily [for >30 days] discontinued study medication) at the
- •time they present for their last double-blind study visit (Month 36/EOT).
- •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 1478
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4682
排除标准
- •1) Sex and reproductive status
- •a) Women who are pregnant or breast feeding
- •b) Women of child bearing potential (WOCBP) who are unwilling to meet the study
- •requirements for pregnancy testing (see section 7.6.1 Requirements for Pregnancy
- •Testing) or are unwilling or unable to use an acceptable method to avoid
- •WOCBP includes any female who has experienced menarche and who has not
- •undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or> 12 consecutive months; or women on hormone replacement therapy (HRT) with
- •documented serum follicle stimulating hormone (FSH) level > 35 m IU/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 of child bearing potential.
- •2) Target Disease Exceptions
- •c) Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis)
- •d) Valvular disease requiring surgery
- •e) Planned atrial fibrillation ablation procedure to be performed within 3 months.
- •3) Medical History and Concurrent Disease
- •f) Conditions other than atrial fibrillation that require chronic anticoagulation (e.g.,
- •prosthetic mechanical heart valve, venous thromboembolism; also see section 5.5
- •Concomitant Treatments).
- •g) Patient with serious bleeding in the last 6 months or at high risk of bleeding. This
- •includes, but is not limited to:
- •Active peptic ulcer disease
- •Platelet count < 100,000/mm3 or hemoglobin < 10g/dL
- •Recent stroke (within 10 days)
- •Documented hemorrhagic tendencies or blood dyscrasias
- •h) Current alcohol or drug abuse, or psychosocial reasons that make study
- •participation impractical
- •i) Severe co-morbid condition with life expectancy <1 year
- •4) Physical and Laboratory Test Findings
- •j) Severe renal insufficiency (creatinine clearance must be calculated in all patients; any patient with either a serum creatinine > 2.5 mg/dL [221 umol/L] or a calculated creatinine clearance < 25 ml/min is excluded)
- •k) ALT or AST > 2 times upper limit of normal or a total bilirubin > 1.5 times upper
- •limit of normal (unless an alternative causative factor [e.g., Gilbert’s syndrome] is
- •identified)
- •5) Allergies and Adverse Drug Reactions
- •None. Allergy or adverse reaction to ASA.
- •6) Prohibited Treatments and/or Therapies
- •l) See section 5.5.1 (Prohibited and/or Restricted Treatments) for therapies which
- •are prohibited at study entry
- •m) Required treatment with a thienopyridine (clopidogrel or ticlopidine; see also
- •section 5.5.2.1 Acetylsalicylic acid (ASA) and Thienopyridines).
- •7) Other Exclusion Criteria
- •n) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated)
- •o) Use of an investigational drug or device within the past 30 days or prior
- •randomization into an apixaban clinical study
- •p) Patients who are compulsorily detained for treatment of either a psychiatric or
- •physical (e.g., infectious disease) illness
- •Eligibility criteria for this study have been carefully considered to ensure the safety of
- •study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.
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研究者
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