Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

Completed

Phase 3 Results

Trial Description

This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).

Detailed Description

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

Conditions

Interventions

  • Warfarin (Coumadin┬«)Drug
    Intervention Desc: Participants orally administered a warfarin potassium tablet (INR [international normalized ratio] target was 1.6-2.6 for patients >70 years and 2.0-3.0 for patients <70 years)
    ARM 1: Kind: Experimental
    Label: Arm 2
    ARM 2: Kind: Experimental
    Label: Warfarin
    Description: Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
  • Xarelto (Rivaroxaban, BAY59-7939) Drug
    Intervention Desc: BAY 59-7939 15mg OD:creatinine clearance >/= 50 mL/minBAY 59-7939 10mg OD:creatinine clearance 30 to 49 mL/min
    ARM 1: Kind: Experimental
    Label: Arm 1
  • Warfarin placebo Drug
    Intervention Desc: Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values)
    ARM 1: Kind: Experimental
    Label: Rivaroxaban (Xarelto, BAY59-7939)
    Description: Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
  • Rivaroxaban placebo Drug
    Intervention Desc: Participants orally administered a rivaroxaban placebo tablet
    ARM 1: Kind: Experimental
    Label: Warfarin
    Description: Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
  • Rivaroxaban (Xarelto, BAY59-7939) Drug
    Intervention Desc: Participants orally administered rivaroxaban 15 mg OD (CrCL [creatinine clearance] >= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min)
    ARM 1: Kind: Experimental
    Label: Rivaroxaban (Xarelto, BAY59-7939)
    Description: Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary (Safety)The composite of major and non-major clinically relevant bleeding events Throughout treatment and followup period Yes
Primary (Efficacy)The composite of stroke and non-CNS systemic embolism Throughout treatment and followup period No
Secondary Each category of bleeding events, and adverse event Throughout treatment and followup period Yes
Secondary The composite of stroke, non-CNS systemic embolism, and vascular death Throughout treatment and followup period No
Primary Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding Up to 2 days after the last dose Yes
Secondary Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism Up to 2 days after the last dose No
Secondary Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death Up to 2 days after the last dose No
Secondary Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death Up to 2 days after the last dose No
Secondary Event Rate of Stroke Up to 2 days after the last dose No
Secondary Event Rate of Non-CNS Systemic Embolism Up to 2 days after the last dose No
Secondary Event Rate of Myocardial Infarction Up to 2 days after the last dose No
Secondary Event Rate of Vascular Death Up to 2 days after the last dose No
Secondary Event Rate of Stroke With Serious Residual Disability Up to 2 days after the last dose No
Secondary Event Rate of All-cause Death Up to 2 days after the last dose No
Secondary Event Rate of Adjudicated Major Bleeding Up to 2 days after the last dose Yes
Secondary Event Rate Adjudicated Non-major Clinically Relevant Bleeding Up to 2 days after the last dose Yes

Sponsors