Resumen

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.

Descripción detallada

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

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio \<0.9)
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
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

Criterios de exclusión

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

Intervenciones

drug

Apixaban

Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks

drug

Acetylsalicylic acid

Tablets, oral, 81-324 mg, once daily, up to 156 weeks

Ubicaciones

Local Institution

Adrogué, Buenos Aires, Argentina

Local Institution

Autonoma Buenos Aires, Buenos Aires, Argentina

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Bahía Blanca, Buenos Aires, Argentina

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Coronel Suárez, Buenos Aires, Argentina

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Haedo, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Merlo, Buenos Aires, Argentina

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Ramos Mejía, Buenos Aires, Argentina

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San Francisco, Córdoba Province, Argentina

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San Salvador de Jujuy, Jujuy Province, Argentina

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Zárate, Provincia Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Buenos Aires, Argentina

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Corrientes, Argentina

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Córdoba, Argentina

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Córdoba, Argentina

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Córdoba, Argentina

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Córdoba, Argentina

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Córdoba, Argentina

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Córdoba, Argentina

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Salta, Argentina

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Santa Fe, Argentina

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

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Apixaban

Acetylsalicylic acid

Ubicaciones

Local Institution

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Patrocinadores