A Phase III Study of Apixaban in Patients With Atrial Fibrillation "AVERROES"

Completed

Phase 3 Results

Trial Description

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.

Detailed 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

Conditions

Interventions

  • Aspirin (acute stroke) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Abciximab (ReoPro┬«)Drug
    Intervention Desc: Intravenous platelet aggregation inhibitor, monoclonal antibody directed against the platelet glycoprotein GP IIb-IIIa receptor
  • Apixaban Drug
    Other Names: BMS-562247
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Apixaban
    Description: (Double-Blind Phase)
    ARM 2: Kind: Experimental
    Label: Apixaban (Long-Term Open-Label Extension)
    Description: (Open Label Phase)
  • Acetylsalicylic acid Drug
    Other Names: Aspirin 81 mg
    Intervention Desc: Tablets, oral, 81-324 mg, once daily, up to 156 weeks
    ARM 1: Kind: Experimental
    Label: Acetylasalicylic acid
  • Acetylsalicylic Acid (ASA) Drug
    Intervention Desc: Tablets, Oral, 81 - 324 mg, QD, Up to 36 months/End of Study
    ARM 1: Kind: Experimental
    Label: Acetylasalicylic Acid (ASA)
    Description: (Double-Blind Phase)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary efficacy outcome will be the time (days) from first dose of study drug to first occurrence of unrefuted ischemic stroke, hemorrhagic stroke or systemic embolism.
Secondary The secondary efficacy outcome will be the time (days) from first dose of study drug to first occurrence of unrefuted Ischemic stroke, hemorrhagic stroke, systemic embolism, myocardial infarction, or vascular death.
Primary The primary efficacy outcome will be the time (days) from first dose of study drug to first occurrence of unrefuted ischemic stroke, hemorrhagic stroke or systemic embolism Time to first occurrence No
Secondary The secondary efficacy outcome will be the time (days) from first dose of study drug to first occurrence of unrefuted Ischemic stroke, hemorrhagic stroke, systemic embolism, myocardial infarction, or vascular death Time to first occurrence No
Primary Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) No
Primary 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) Yes
Secondary Event Rates of Major Vascular Events (Stroke/Systemic Embolism, Myocardial Infarction, Death) in the Intended-treatment Period Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) No
Secondary 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 No
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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) No

Sponsors