Impact of Apixaban on Clinical Outcome of the Patients With Large Vessel Occlusion or Stenosis Trial "ALVO"

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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

Conditions

Interventions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Any adult patient with acute stroke who treated with apixaban.

Outcomes

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

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