Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatments apixaban, acetylsalicylic acid
Phase phase 3
Sponsor Bristol-Myers Squibb
Collaborator Pfizer
Start date August 2007
End date November 2010
Trial size 6421 participants
Trial identifier NCT00496769, CV185-048

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
apixaban BMS-562247
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
(Active Comparator)
acetylsalicylic acid
Tablets, oral, 81-324 mg, once daily, up to 156 weeks

Primary Outcomes

Measure
Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period
time frame: 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
time frame: Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

Secondary Outcomes

Measure
Event Rates of Major Vascular Events (Stroke/Systemic Embolism, Myocardial Infarction, Death) in the Intended-treatment Period
time frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period
time frame: 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 Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome
time frame: 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
time frame: 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)
time frame: 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)
time frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death
time frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

Eligibility Criteria

Male or female participants at least 50 years old.

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: - 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 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: - 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

Additional Information

Official title 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
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.