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
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
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.
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
Key Inclusion Criteria:
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:
Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:
Key Exclusion Criteria:
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:
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
Palm Springs, California 92262, United States
Autonoma Buenos Aires, Buenos Aires C1119ACN, Argentina
San Jose- Do Rio Preto, São Paulo 15015, Brazil
Saint Georges Beauce, Quebec G5Y 4W1, Canada
Havirov - Mesto, 736 01, Czechia
Arhus C, 8000, Denmark
Hyderabad, Andhra Pradesh 500001, India
Banglore, Karnataka 560054, India
Jakarta Timur, 13750, Indonesia
San Daniele de Friuli (ud), 33038, Italy
Cheras, Kuala Lumpur 56000, Malaysia
Pulau Pinang, Pulau Pinang 10990, Malaysia
San Luis Potosi, Slp, San Luis Potosí 78240, Mexico
Fyllingsdal, 5145, Norway
Bellville, Cape Town, Western Cape 7530, South Africa
Newcastle Upon, Tyne and Wear NE2 4HH, United Kingdom