The aim of this study is to investigate the clinical events of the patients with acute cerebral large vessel occlusion or stenosis and atrial fibrillation, treated by apixaban within 14 days after onset. This is the observational study that patients will be made the registration at the timing of both retrospective period and prospective period.
Four novel oral anticoagulants (NOACs) have been released to the market ahead of any county in the world. However, no information is available on the clinical results of NOACS and their secondary preventive effects in Japanese population.
Medical care for acute-phase stroke is constantly advancing. Specifically, in addition to thrombolytic activator tissue plasminogen activator (t-PA), advancement of endovascular thrombectomy has made it possible to treat patients who would not have been saved otherwise. In Japan, cerebrovascular accident had been the third leading cause of death, but now has dropped to the forth thanks to wide use of various treatments. Nevertheless, patients often suffer from severe sequelae after stroke, even if they survive. In other words, major challenge in the treatment of stroke is not only to save the patients but also to improve the long-term prognosis.
In large-scale study, NOAC showed an equal to or greater efficacy in preventing recurrence of stroke compared with warfarin and significantly reduced the incidence of bleeding complications. Furthermore, Aristotle trial comparing apixaban vs. warfarin demonstrated that apixaban provided a significant prevention of stroke recurrence as well as significant reduction of bleeding complications and deaths.
Heparin and warfarin had been used as the mainstream agents for the prevention of recurrence after hyperacute phase treatment.However, Aristotle trial showed that there was a significant difference in thromboembolic events between apixaban treatment (1.27 %/year) and warfarin (1.60%/year) (RR 0.79, p<0.01). Also, major bleeding events were less frequent in the patients with apixaban treatment (2.13 %/year) compared to those with warfarin (3.09%/year) (RR 0.69, p<0.001). This study is conducted on the basis of expectation that the use of apixaban in place of traditional warfarin therapy further improve prognosis and reduce bleeding complications in Japanese patients with acute occlusion of major cerebral artery. Additionally, the study will analyze the correlation of the use of apixaban with the prognosis and the incidence of bleeding/ischemic events in patients with intracranial artery stenosis greater than 50% and with atrial fibrillation
- Apixisaban Drug
Other Names: eliquis
- Observation: Cohort
- Perspective: Prospective
- Sampling: Non-Probability Sample
Any adult patient with acute stroke who treated with apixaban.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Death||90 days after disease onset||Yes|
|Primary||Ischemic events||90 days after disease onset||Yes|
|Primary||Bleeding events||90 days after disease onset||Yes|
|Secondary||modified Rankin Scale||90 days (±10 days) and 365days（±10 days） after disease onset||No|
|Secondary||Ischemic event||30 days and 365day||Yes|
|Secondary||Bleeding event||30 days and 365day||Yes|
|Secondary||Significant bleeding (ISTH)||30 days 90 days (±10 days) and 365day||Yes|
|Secondary||Symptomatic intracranial hemorrhage (sICH)||0 days, 90 days and 365days||Yes|
|Secondary||Ischemic stroke and systemic embolism||30 days, 90 days and 365days||Yes|