Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation
Status:
Recruiting
Trial end date:
2021-12-30
Target enrollment:
Participant gender:
Summary
Anticoagulant treatment for non-valvular atrial fibrillation (AF) associated with cerebral
infarction/ TIA is one of the recognized treatment of stroke prevention. The ACC/AHA and
national guidelines for the management of anticoagulation recommend that most of AF patients
with cerebral infarction or TIA should be administrated anticoagulant therapy within 14 days
of symptom onset, while European guidelines recommend that the timing of the initiation of
non-vitamin K antagonist oral anticoagulants (NOACs) for AF patients with cerebral infarction
or TIA is association with stroke severity in light of the "1-3-6-12" principle. However,
there are still many problems about the use of NOACs in ischemic stroke with AF. for example,
it is unclear what time to begin NOACs as to difference in stroke severity, ages, comorbidity
with hypertension, diabetes, heart failure, liver and kidney dysfunction and bleeding risks.
Thus, the timing of the initiation of NOACs is yet to be further studied. Current urgent need
is to develop a guideline-based specific regimen in which the benefit-risk factors are
further balanced with a combination of NHISS, CHA2DS2-VASC and HAS-BLED score.
Rivaroxaban, a direct coagulation factor Ⅹa inhibitor, blocks the formation of the clot.
ROCKET-AF study has shown that the efficacy of rivaroxaban is not inferior to that of
warfarin in AF patients on stroke prevention, and rivaroxaban has a significantly decreased
bleeding risk compared with warfarin. Recent study indicates that early administration with
rivaroxaban for AF patients within 14 days of onset does not significantly increase
hemorrhagic transformation. However, the relevant clinical data of the efficacy and safety of
early initiation of rivaroxaban in AF patients with cerebral infarction or TIA are lacking in
China.
Therefore, the investigators conduct a multicenter cohort study to investigate the safety of
early rivaroxaban in the AF patient with cerebral infarction or TIA within 12 days of onset.