BACKGROUND: @entity63 ( @entity63 ) or minor @entity385 represents the largest group of @entity66 , and those @entity1 have a high risk of early recurrent @entity64 . Over decades, anticoagulation therapy has been used prudently in them for likely increasing the risk of @entity548 . However, recently @entity3925 , a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of @entity932 . Therefore, we assumed that @entity1 may benefit from @entity3925 if treated soon after @entity63 or @entity64 , and designed this adequately powered randomized study, TRACE. METHODS AND DESIGN: The Treatment of @entity3925 versus @entity117 in Non-disabling Cerebrovascular Events (TRACE) study is a randomized, double-blind clinical trial with a target enrollment of 4400 @entity1 . A 14-days regimen of @entity3925 10  mg daily or a 14-days regimen of @entity117 100  mg daily will be administrated to randomized @entity1 with acute @entity63 or @entity64 , defined as National Institute of Health Stroke Scale scores  <=3. The primary efficacy end point is percentage of @entity1 with any @entity64 ( @entity548 ) at 14  days. Study visits will be performed at the day of randomization, day 14 and day 90. DISCUSSION: Even though the new oral anticoagulants seem to be both safe and effective, few clinical trials have been carried out to test their effect on non-disabling cerebrovascular events. Treatment with @entity3925 may prevent more cerebrovascular events with an acceptable risk profile after @entity63 or @entity64 , compared with @entity117 , thus helping to improve the outcome of the disease. TRIAL REGISTRATION: No. NCT01923818.

Treatment of @entity3925 versus XXXX for Non-disabling Cerebrovascular Events (TRACE): study protocol for a randomized controlled trial.

@entity1 :: ('9606', 'Species') :: ['participants', 'patients'] @entity64 :: ('MESH:D020521', 'Disease') :: ['stroke', 'minor stroke'] @entity932 :: ('MESH:D020300', 'Disease') :: ['intracranial hemorrhage'] @entity66 :: ('MESH:D004194', 'Disease') :: ['cerebrovascular disease'] @entity548 :: ('MESH:D006470', 'Disease') :: ['intra-/extra-cranial hemorrhagic complications', 'ischemic or hemorrhage'] @entity63 :: ('MESH:D007511', 'Disease') :: ['Transient ischemic attack', 'TIA'] @entity117 :: ('MESH:D001241', 'Chemical') :: ['Aspirin', 'aspirin'] @entity3925 :: ('MESH:C503223', 'Chemical') :: ['Rivaroxaban', 'rivaroxaban'] @entity385 :: ('MESH:D002544', 'Disease') :: ['ischemic stroke']
@entity117 :: (MESH:D001241,Chemical) :: ['Aspirin']
