Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS) "NAVIGATE ESUS"

Active, not recruiting

Phase 3 Results N/A

Trial Description

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

Detailed Description

The decision to terminate the study due to no efficacy improvement over aspirin at an interim analysis and very little chance of showing overall benefit if study was completed was taken in September and communicated via press release. For transparency purpose, we communicated this status on clinicaltrials.gov. however, few patients remained in the study for follow up, and there is no completion date yet. Therefore, we updated the status back to "active, not recruiting", till all data regarding patient in follow up have been collected and we can provide a completion date.

Conditions

Interventions

  • Rivaroxaban (Xarelto, BAY59-7939) Drug
    Intervention Desc: 15 mg, once daily, orally, tablet
    ARM 1: Kind: Experimental
    Label: Rivaroxaban
    Description: Rivaroxaban 15 mg orally once daily
  • Aspirin (Acetylsalicylic acid, BAY1019036) Drug
    Intervention Desc: 100 mg, once daily, orally, tablet
    ARM 1: Kind: Experimental
    Label: Aspirin
    Description: Aspirin 100 mg orally once daily
  • Rivaroxaban-Placebo Other
    Intervention Desc: Matching placebo, once daily, orally, tablet
    ARM 1: Kind: Experimental
    Label: Rivaroxaban
    Description: Rivaroxaban 15 mg orally once daily
  • Aspirin-Placebo Other
    Intervention Desc: Matching placebo, once daily, orally, tablet
    ARM 1: Kind: Experimental
    Label: Aspirin
    Description: Aspirin 100 mg orally once daily

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Time from randomization to first occurrence of any of the components of the composite outcome (adjudicated), including: Stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging), Systemic embolism Approximately 3 years No
Primary Time from randomization to the first occurrence of major bleeding (acc. to the International Society on Thrombosis and Haemostasis) Approximately 3 years Yes
Secondary Time from randomization to first occurrence of any of the following: Cardiovascular death (including death due to hemorrhage), recurrent stroke, systemic embolism, and myocardial infarction Approximately 3 years No
Secondary Time from randomization to first occurrence of: All cause mortality Approximately 3 years No
Secondary Time from randomization to first occurrence of any of the following: stroke, CV death, and myocardial infarction as well as ischemic stroke, and disabling stroke (modified Rankin score 4 and 5) Approximately 3 years No
Secondary Time from randomization to the first occurrence of life-threatening bleeding Approximately 3 years Yes
Secondary Time from randomization to the first occurrence of clinically relevant non-major bleeding Approximately 3 years Yes
Secondary Time from randomization to the first occurrence of intracranial hemorrhage Approximately 3 years Yes
Secondary Time from randomization to first occurrence of: Individual components of the primary and secondary efficacy outcomes (stroke, CV death, and myocardial infarction) as well as ischemic stroke, and disabling stroke (modified Rankin score 4 and 5) Approximately 3 years No

Sponsors