RATIONALE: @entity1 with @entity955 ( @entity955 ) in the acute stage of @entity385 or @entity63 ( @entity63 ) are at high risk of recurrent @entity64 , but the optimal anticoagulation strategy remains unclear due to the concern of @entity510 . Novel oral anticoagulants compared to @entity1229 might be more safe and efficacious in @entity1 suitable for early anticoagulation. AIMS: This trial is to evaluate the feasibility of early anticoagulation with @entity3925 in acute @entity385 or @entity63 @entity1 with @entity955 . DESIGN: This is a randomized, open-label, blinded endpoint evaluation trial. Inclusion criteria are (1) @entity955 , (2) presumed @entity64 or @entity63 ( @entity63 ) confirmed by MRI within five-days from onset, and (3) mild to moderate @entity64 severity. We will randomize 196 @entity1 to either @entity3925 (10   mg once daily for five-days followed by 15   mg or 20   mg once daily) or dose-adjusted @entity1229 (coadministration of @entity117 100   mg per day until achieving international normalized ratio of 1  7). The study is registered in ClinicalTrials.gov (NCT02042534). STUDY OUTCOMES: The primary endpoint is the composite of recurrent @entity2806 and @entity510 on MRI at four-weeks. Secondary endpoints are recurrent @entity2806 , @entity510 , major @entity548 , major vascular events, four-week modified Rankin Scale score, and duration of hospitalization after randomization. DISCUSSION: The results of this proof-of-concept trial will guide go/no-go decision to a large phase 3 confirmatory trial.

Rationale and design of Triple AXEL: trial for early anticoagulation in acute @entity385 XXXX with nonvalvular @entity955 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity64 :: ('MESH:D020521', 'Disease') :: ['cardioembolic stroke', 'stroke'] @entity2806 :: ('MESH:D002545', 'Disease') :: ['ischemic lesion', 'ischemic lesions'] @entity63 :: ('MESH:D007511', 'Disease') :: ['transient ischemic attack', 'TIA'] @entity510 :: ('MESH:D013345', 'Disease') :: ['intracranial bleeding'] @entity548 :: ('MESH:D006470', 'Disease') :: ['bleeding'] @entity117 :: ('MESH:D001241', 'Chemical') :: ['aspirin'] @entity3925 :: ('MESH:C503223', 'Chemical') :: ['rivaroxaban'] @entity955 :: ('MESH:D001281', 'Disease') :: ['atrial fibrillation', 'nonvalvular AF', 'AF'] @entity1229 :: ('MESH:D014859', 'Chemical') :: ['warfarin'] @entity385 :: ('MESH:D002544', 'Disease') :: ['ischemic stroke']
@entity1 :: (9606,Species) :: ['patients']
