An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
Condition: Atrial Fibrillation; Stroke; Embolism
MeSH terms: Stroke; Atrial Fibrillation; Embolism
Intervention: Rivaroxaban; Warfarin; Matching placebo for Rivaroxaban arm (Warfarin placebo); Matching placebo for Warfarin arm (Rivaroxaban placebo)
Intervention description: Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years); Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use. Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years; Form=tablet, route=oral. One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years; Form-tablet, Route=oral administration. Number of rivaroxaban placebo determined by the number of warfarin tablets taken. Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years
Intervention MeSH terms: Warfarin; Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14269.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Stroke; Embolism; Non-central nervous system systemic embolism; Non-valvular atrial fibrillation; Blood Clot; Rivaroxaban; Warfarin; Anticoagulants; Arrhythmias, Cardiac

Summary:

      The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin
      for the prevention of blood clots in the brain (referred to as stroke) and blood clots in
      other parts of the body referred to as non-central nervous system systemic embolism) in
      patients with non-valvular atrial fibrillation (a heart rhythm disorder).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have documented atrial fibrillation on 2 separate occasions within 6
             months before screening

          -  History of a prior stroke, transient ischemic attack or non-neurologic systemic
             embolism believed to be cardiac in origin, or at least two of the following risk
             factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus

        Exclusion Criteria:

          -  Significant mitral stenosis

          -  Transient atrial fibrillation caused by a reversible disorder

          -  Active internal bleeding

          -  Severe disabling stroke

          -  History of intracranial bleeding

          -  Hemorrhagic disorders