Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation "ARISTOTLE"

Completed

Phase 3 Results

Trial Description

The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

Conditions

Interventions

  • Warfarin (Coumadin┬«)Drug
    Intervention Desc: Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)
    ARM 1: Kind: Experimental
    Label: 1
  • Apixaban Drug
    Other Names: BMS-562247
    Intervention Desc: Oral tablets, 5.0 mg or 2.5 mg, twice daily
    ARM 1: Kind: Experimental
    Label: 2

Trial Design

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

Patient Involvement

Subjects will be randomized to one of two arms:1: Active Comparator Drug: warfarin Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0) or 2: Experimental Drug: apixaban Oral tablets, 5.0 mg, twice daily.

Outcomes

Type Measure Time Frame Safety Issue
Primary Confirmed stroke or systemic embolism.
Secondary Confirmed ischemic stroke, hemorrhagic stroke, systemic embolism, all cause death.
Primary confirmed stroke or systemic embolism Time to first occurrence Yes
Secondary confirmed ischemic stroke, hemorrhagic stroke, systemic embolism, all cause death Time to first occurrence Yes
Primary Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period Time to first event in "Intended Treatment Period": started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding). No
Primary Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period "Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding). No
Primary Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period "Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group. Yes
Primary Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period "Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group. Yes
Secondary Number of Participants With Events of All-Cause Death During the Intended Treatment Period "Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding). No
Secondary Rate of Adjudicated All-Cause Death During the Intended Treatment Period "Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding). No
Secondary Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period "Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding). No
Secondary Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period "Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding). No
Secondary Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period "Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding). No
Secondary Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period "Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding). No
Secondary Number of Participants With Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period "Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group. Yes
Secondary Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period "Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group. Yes
Secondary Number of Participants With All Bleeding Events During Treatment Period "Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group. Yes
Secondary Rate of All Bleeding Events During Treatment Period "Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group. Yes
Secondary Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period "Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group. Yes

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