Unique ID issued by UMIN | UMIN000022652 |
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Receipt number | R000026114 |
Scientific Title | Impact of Apixaban on clinical outcome of the patients with Large Vessel Occlusion or stenosis |
Date of disclosure of the study information | 2016/06/08 |
Last modified on | 2021/06/17 11:02:01 |
Impact of Apixaban on clinical outcome of the patients with Large Vessel Occlusion or stenosis
ALVO trial
Impact of Apixaban on clinical outcome of the patients with Large Vessel Occlusion or stenosis
ALVO trial
Japan |
Acute ischemic stroke
Neurosurgery |
Others
NO
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.
Safety,Efficacy
Death and ischemic/bleeding events within 90 days after disease onset
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
700
1st name | |
Middle name | |
Last name | Shinichi Yoshimura |
Hyogo College of Medicine
Department of Neurosurgery
1-1 Mukogawa, Nishinomiya, Hyogo 663-8501
+81-798-45-6455
alvo@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Kazutaka Uchida |
Hyogo College of Medicine
Department of Neurosurgery
1-1 Mukogawa, Nishinomiya, Hyogo 663-8501
+81-798-45-6455
alvo@hyo-med.ac.jp
Hyogo college of medicine
Hyogo College of Medicine
Bristol-Myers Squibb
Profit organization
NO
2016 | Year | 06 | Month | 08 | Day |
http://www.clinicaltrials.gov. NCT02818868
Published
http://www.clinicaltrials.gov. NCT02818868
713
The cumulative incidence of primary outcome was similar between the two groups. The crude HR of the Early group was 1.19 and the adjusted HR was 1.32 within 365 days.
2021 | Year | 06 | Month | 17 | Day |
The inclusion criteria were patients aged at least 20 years, with acute ischemic stroke with LVO or intra-/ extra-cranial artery stenosis and NVAF, and received apixaban within 14 days after the onset. To reflect the real- world clinical practice of LVO, we included peripheral artery occlusions such as M2-3, A1-2, or P1-2. We also included acute ischemic stroke with intra-/extra-cranial artery stenosis defined as over 50%, because anticoagulants were considered effective in patients with concomitant atherosclerotic diseases and NVAF [11, 12]. On the contrary, the exclusion criteria were patients who are considered ineligible for the study by the investigator, pregnant or potentially pregnant, have a his- tory of hypersensitivity to apixaban, with hepatic disease hav- ing coagulation disorder and clinically important bleeding risk, with renal failure (creatinine clearance < 15 mL/min), and with pathological bleeding including intracranial bleeding of any type. The diagnostic and treatment modalities were determined by the physician-in-charge including rt-PA and EVT. The rt-PA used was alteplase, which was administered intravenously at 0.6 mg/kg [13], and EVT consisted of any type of intravascular therapy including thrombectomy using any device approved in Japan.
We initially registered 713 patients, and 27 patients were ex- cluded due to ineligibility, duplicate registration, and refusal to provide informed consent. The median time from onset to apixaban administration was 2.5 days . There were 263 and 423 patients in the Early and Late groups, respectively. The mean age (SD) of enrolled patients was 77.5 (9.7) years, and men accounted for 52 of the patients. Overall, 138 (20.1) and 160 (23.3) patients received antiplatelet and anticoagulant drugs before the onset, respectively. The rt-PA and EVT were conducted in 268 (39.1) and 358 (52.2) patients, respectively. Two-thirds of the patients had no dis- ability (mRS 0) before onset.
Ischemic events before apixaban administration occurred in three cases, which were all cerebral infarctions in the Late group. Their ASPECTS on admission were 2, 7, and 8 points. In addition, all ischemic events occurred on the 3rd day after the onset.
We tabulated the details of ISTH major bleeding events within 30 days after apixaban administration (Supplemental Table III). Eight of nine patients in the Early group and 7 of 12 patients in the Late group received rt-PA or EVT. The background of patients who developed bleeding events in 30 days was generally similar between the groups.
The primary outcome of this analysis was a composite of all- cause death, International Society on Thrombosis and Haemostasis (ISTH) major bleeding events, [21], and ische- mic events. Ischemic events included ischemic stroke, acute coronary syndrome, acute myocardial infarction, or systemic embolism after apixaban administration. The secondary out- comes were each component of the primary outcome. Additionally, we assessed intracranial hemorrhage and ische- mic stroke separately due to a safety concern. We analyzed these outcomes at 30, 90, and 365 days after the onset.
Completed
2016 | Year | 05 | Month | 02 | Day |
2016 | Year | 03 | Month | 10 | Day |
2016 | Year | 06 | Month | 01 | Day |
2019 | Year | 05 | Month | 31 | Day |
observational study
2016 | Year | 06 | Month | 08 | Day |
2021 | Year | 06 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026114
Research Plan | |
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Registered date | File name |
2021/06/17 | ALVO_Protoco_Ver2.3.docx |
Research case data specifications | |
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Registered date | File name |
2021/06/17 | Yoshimura_et_al-2020-Translational_Stroke_Research.pdf |
Research case data | |
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Registered date | File name |
2021/06/17 | Yoshimura_et_al-2020-Translational_Stroke_Research.pdf |