Purpose

Objectives

Category

IRB Number
20180178HU
NCT Number
NCT03192215
Open to Enrollment
Yes
Sponsor
Columbia University -



Study Contact

Principal Investigator
Reza Behrouz

Regulatory Point of Contact
Charlotte Rhodes
(210) 450-8454
rhodesc1@uthscsa.edu



Eligibility

Eligible Ages
Over 45 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 3
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Intervention Model Description
      Active treatment will be either apixaban 5 mg or aspirin 81 mg. An adjusted dose of apixaban 2.5 mg will be used for subjects with at least two of the following: age greater than or equal to 80 years, body weight less than or equal to 60 kg, or known serum creatinine greater than or equal to 1.5 mg/dL. There will be six possible study tablets: apixaban 5 mg (regular dose), apixaban 2.5 mg (adjusted dose), apixaban 5 mg placebo, apixaban 2.5 mg placebo, aspirin 81 mg, and aspirin placebo. All subjects will be randomized to receive active treatment with either active apixaban or active aspirin. Study treatments will be supplied in a double-dummy fashion as apixaban 5 mg (2.5 mg for the adjusted dose) or matching placebo, and aspirin 81 mg or matching placebo.
      Primary Purpose
      Prevention
      Masking
      Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
      Masking Description
      Eligible patients will be allocated in a 1:1 ratio to apixaban or aspirin using the minimal sufficient balance randomization method to prevent serious treatment imbalances by study site.
      Condition
    1. Stroke
    2. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Active agent: Apixaban

      Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
    3. Drug: Apixaban

      5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).

      Other names:

      • Eliquis

    4. Active Comparator

      Active control: Aspirin

      Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
    5. Drug: Aspirin

      Aspirin 81 mg by mouth once daily.

      Other names:

      • Aspirin Tablet