Ischemic Stroke
Conditions
Brief summary
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
Interventions
DRUGapixisaban
Sponsors
Hyogo Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 20 years and older with acute stroke and treated with oral apixaban within 14 days after onset. 2. Patients who are hospitalized in a period from Oct 1, 2014 to Feb 28, 2018 3. Patients with acute cerebral large vessel occlusion or stenosis (\> 50%) 4. Patients with non-valvular atrial fibrillation 5. Patients who are not confirmed ICH by MRI or CT within 24 hours after r-tPA infusion.
Exclusion criteria
1. Patients who are considered to be ineligible for the study participation by the investigator. 2. Patients who are pregnant or potentially pregnant. 3. Patients who have a history of hypersensitivity to apixaban 4. Patients with hepatic disease having coagulation disorder and clinically important bleeding risk 5. Patients with renal failure (creatinine clearance \< 15 mL/min) 6）Patients with Active pathological bleeding including intracranial bleeding of any type
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death | 90 days after disease onset |
| Ischemic events | 90 days after disease onset |
| Bleeding events | 90 days after disease onset |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding event | 30 days and 365day | — |
| Significant bleeding (ISTH) | 30 days 90 days (±10 days) and 365day | scale bleeding events Among the major bleeding , according to the society and hemostasis of international thrombosis (ISTH) bleeding criteria , those that fall under any of the following criteria . 1. lethal bleeding 2. important sites or symptomatic bleeding of organs ( intracranial, bone marrow , in the eye , retroperitoneal , intra-articular , or heart sac bleeding , or muscle hemorrhage with a compartment syndrome ) 3. hemoglobin value has decreased 2 g / dL or more bleeding , whole blood transfusion or red blood cells ( more than 2 units) bleeding that required blood transfusion |
| modified Rankin Scale | 90 days (±10 days) and 365days（±10 days） after disease onset | — |
| Ischemic stroke and systemic embolism | 30 days, 90 days and 365days | systemic embolism defined as an event in which the cases with embolism of extremity arteries, intestinal arteries, renal arteries, etc., accompanied by symptoms of local organs. |
| Symptomatic intracranial hemorrhage (sICH) | 0 days, 90 days and 365days | scale Symptomatic intracranial hemorrhage (SICH): new intracranial hemorrhage , which corresponds to one of the following: 1\) which compared to the worse just before the NIHSS, admitted the deterioration of more than 4 points 2 ) that recognized the deterioration of two or more points in one of the NIHSS category 3 ) intubation / outside decompression / drainage detention or other things that led to the expensive medical / surgical intervention 4 ) it is not a worsening due to other causes |
| Death | 30 days and 365day | — |
| Ischemic event | 30 days and 365day | — |
Countries
Japan
Outcome results
None listed