Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation

  • STATUS
    Recruiting
  • days left to enroll
    67
  • participants needed
    1000
  • sponsor
    General Hospital of Shenyang Military Region
Updated on 11 February 2021
diabetes
stroke
heart failure
warfarin
anticoagulants
infarct
cerebral infarction
deficit
anticoagulant therapy
coagulation factor

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 a 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.

Details
Condition Cerebrovascular accident, Cerebral Infarction, Cerebral Ischemia, Transient Ischemic Attack, Stroke, transient ischemic attacks
Treatment Rivaroxaban
Clinical Study IdentifierNCT03749057
SponsorGeneral Hospital of Shenyang Military Region
Last Modified on11 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Over 18 years
Acute cerebral infarction caused by non-valvular atrial fibrillation
NIHSS score 15
Within 12 days of onset
first stroke onset or past stroke without obvious neurological deficit (mRS score1)
Signed informed consent

Exclusion Criteria

Hemorrhagic stroke or mixed stroke
Patients with valvular atrial fibrillation or non-cardiogenic cerebral infarction
Patients with severe infection or serious diseases
Gastrointestinal bleeding or major operation within 3 months
Planed cerebrovascular reconstruction or cardiac surgery within 3 months
Planed major surgery within 3 months
Participating in other clinical trials within 3 months
Unsuitable for this trial assessed by research
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