NCT00496769已完成3 期
Apixaban Versus Acetylsalicylic 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
Bristol-Myers Squibb68 个研究点 分布在 1 个国家目标入组 6,421 人开始时间: 2007年8月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,421
- 试验地点
- 68
- 主要终点
- Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period
研究概览
简要总结
The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.
详细描述
An optional Long-term Open-label Extension Phase of treatment with apixaban will be provided for qualifying participants following the conclusion of the double-blind phase
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female
- •Age of 50 years or older
- •Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)
- •At least 1 of the following risk factors for stroke:
- •Prior stroke or transient ischemic attack
- •Age of 75 years or older
- •Arterial hypertension on treatment
- •Diabetes mellitus
- •Heart failure (New York Health Authority Class 2 or greater at time of enrollment)
- •Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment
- •Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio <0.9)
- •Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:
- •Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued
- •Vitamin K antagonist therapy not previously used but expected unsuitable
排除标准
- •Women who are pregnant or breast feeding
- •Women of child bearing potential who are unwilling to meet the study requirements for pregnancy testing or are unwilling or unable to use an acceptable method to avoid pregnancy
- •Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis
- •Valvular disease requiring surgery
- •Planned ablation procedure for atrial fibrillation to be performed within 3 months
- •Conditions other than atrial fibrillation that require chronic anticoagulation (such as, prosthetic mechanical heart valve, venous thromboembolism)
- •Patients with serious bleeding in the last 6 months or at high risk for bleeding, including but not limited to those with:
- •Active peptic ulcer disease
- •Platelet count <100,000/mm^3 or hemoglobin <10g/dL
- •Recent stroke (within 10 days)
- •Documented hemorrhagic tendencies or blood dyscrasias
- •Current alcohol or drug abuse or psychosocial reasons that make study participation impractical
- •Severe comorbid condition with life expectancy <1 year
- •Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a calculated creatinine clearance <25 mL/min is excluded
- •Alanine transaminase or aspartate aminotransferase levels >2 times upper limit of normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative causative factor [such as Gilbert's syndrome] is identified)
- •Allergy or adverse reaction to acetylsalicylic acid
- •Required treatment with a thienopyridine (clopidogrel or ticlopidine)
- •Prisoners or participants who are compulsory detained (involuntarily incarcerated)
- •Use of an investigational drug or device within the past 30 days or prior randomization into an apixaban clinical study
- •Patients who are compulsorily detained for treatment for a psychiatric or physical illness
研究组 & 干预措施
Apixaban
Experimental
干预措施: Apixaban (Drug)
Acetylasalicylic acid
Active Comparator
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period
时间窗: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)
次要结局
- Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period(First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010)
- Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality(First dose of study drug (Day 1) to 30 days after last dose of blinded study drug)
- Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period(Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy))
- Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death(Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy))
- Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period(Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy))
- Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome(First dose of study drug (Day 1) to 30 days after last dose of blinded study drug)
- Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)(First dose of study drug (Day 1) to 30 days after last dose of blinded study drug)
研究者
研究点 (68)
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