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

December 20, 2021 updated by: Shinichi Yoshimura, Hyogo College of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 665-8501
        • Hyogo collage of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any adult patient with acute stroke who treated with apixaban.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 90 days after disease onset
90 days after disease onset
Ischemic events
Time Frame: 90 days after disease onset
90 days after disease onset
Bleeding events
Time Frame: 90 days after disease onset
90 days after disease onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale
Time Frame: 90 days (±10 days) and 365days（±10 days） after disease onset
90 days (±10 days) and 365days（±10 days） after disease onset
Death
Time Frame: 30 days and 365day
30 days and 365day
Ischemic event
Time Frame: 30 days and 365day
30 days and 365day
Bleeding event
Time Frame: 30 days and 365day
30 days and 365day
Significant bleeding (ISTH)
Time Frame: 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
30 days 90 days (±10 days) and 365day
Symptomatic intracranial hemorrhage (sICH)
Time Frame: 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
0 days, 90 days and 365days
Ischemic stroke and systemic embolism
Time Frame: 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.
30 days, 90 days and 365days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyogo College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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