AzTrials
AzTrials

Ischemic StrokeALVONCT02818868

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

An observational study of Ischemic Stroke, run by Hyogo Medical University at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
apixisaban
How many people
700 participants
Where
1 siteJapan
Study dates
Jul 2016to Feb 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Any adult patient with acute stroke who treated with apixaban.

Who may be able to join

  • Patients 20 years and older with acute stroke and treated with oral apixaban within 14 days after onset.
  • Patients who are hospitalized in a period from Oct 1, 2014 to Feb 28, 2018
  • Patients with acute cerebral large vessel occlusion or stenosis (> 50%)
  • Patients with non-valvular atrial fibrillation
  • Patients who are not confirmed ICH by MRI or CT within 24 hours after r-tPA infusion.

Who cannot join

  • Patients who are considered to be ineligible for the study participation by the investigator.
  • Patients who are pregnant or potentially pregnant.
  • Patients who have a history of hypersensitivity to apixaban
  • Patients with hepatic disease having coagulation disorder and clinically important bleeding risk
  • Patients with renal failure (creatinine clearance < 15 mL/min) 6）Patients with Active pathological bleeding including intracranial bleeding of any type

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Hyogo collage of Medicine

    Nishinomiya, Hyōgo, 665-8501

Other trials in Japan

About this study

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.

Read the 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
Ischemic Stroke
Being tested
apixisaban
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • apixisabanDrug

    Also called eliquis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death

    Measured: 90 days after disease onset

  2. Ischemic events

    Measured: 90 days after disease onset

  3. Bleeding events

    Measured: 90 days after disease onset

Secondary outcomes (7)

  1. modified Rankin Scale

    Measured: 90 days (±10 days) and 365days（±10 days） after disease onset

  2. Death

    Measured: 30 days and 365day

  3. Ischemic event

    Measured: 30 days and 365day

  4. Bleeding event

    Measured: 30 days and 365day

  5. Significant bleeding (ISTH)

    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

    Measured: 30 days 90 days (±10 days) and 365day

  6. Symptomatic intracranial hemorrhage (sICH)

    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

    Measured: 0 days, 90 days and 365days

  7. Ischemic stroke and systemic embolism

    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.

    Measured: 30 days, 90 days and 365days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02818868
Sponsor's protocol ID
2157
Acronym
ALVO
Status last verified
Nov 2016
First submitted
7 Jun 2016
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Hirano T, Sasaki M, Mori E, Minematsu K, Nakagawara J, Yamaguchi T; Japan Alteplase Clinical Trial II Group. Residual vessel length on magnetic resonance angiography identifies poor responders to alteplase in acute middle cerebral artery occlusion patients: exploratory analysis of the Japan Alteplase Clinical Trial II. Stroke. 2010 Dec;41(12):2828-33. doi: 10.1161/STROKEAHA.110.594333. Epub 2010 Oct 28.

    PubMed 21030700

  • Rha JH, Saver JL. The impact of recanalization on ischemic stroke outcome: a meta-analysis. Stroke. 2007 Mar;38(3):967-73. doi: 10.1161/01.STR.0000258112.14918.24. Epub 2007 Feb 1.

    PubMed 17272772

  • Ogawa A, Mori E, Minematsu K, Taki W, Takahashi A, Nemoto S, Miyamoto S, Sasaki M, Inoue T; MELT Japan Study Group. Randomized trial of intraarterial infusion of urokinase within 6 hours of middle cerebral artery stroke: the middle cerebral artery embolism local fibrinolytic intervention trial (MELT) Japan. Stroke. 2007 Oct;38(10):2633-9. doi: 10.1161/STROKEAHA.107.488551. Epub 2007 Aug 16.

    PubMed 17702958

  • Lewandowski CA, Frankel M, Tomsick TA, Broderick J, Frey J, Clark W, Starkman S, Grotta J, Spilker J, Khoury J, Brott T. Combined intravenous and intra-arterial r-TPA versus intra-arterial therapy of acute ischemic stroke: Emergency Management of Stroke (EMS) Bridging Trial. Stroke. 1999 Dec;30(12):2598-605. doi: 10.1161/01.str.30.12.2598.

    PubMed 10582984

  • IMS II Trial Investigators. The Interventional Management of Stroke (IMS) II Study. Stroke. 2007 Jul;38(7):2127-35. doi: 10.1161/STROKEAHA.107.483131. Epub 2007 May 24.

    PubMed 17525387

  • Cass AS, Cass BP, Veeraraghavan K. Immediate exploration of the unilateral acute scrotum in young male subjects. J Urol. 1980 Dec;124(6):829-32. doi: 10.1016/s0022-5347(17)55687-6.

    PubMed 7441833

  • Kelly ME, Furlan AJ, Fiorella D. Recanalization of an acute middle cerebral artery occlusion using a self-expanding, reconstrainable, intracranial microstent as a temporary endovascular bypass. Stroke. 2008 Jun;39(6):1770-3. doi: 10.1161/STROKEAHA.107.506212. Epub 2008 Apr 3.

    PubMed 18388338

  • Mocco J, Hanel RA, Sharma J, Hauck EF, Snyder KV, Natarajan SK, Linfante I, Siddiqui AH, Hopkins LN, Boulos AS, Levy EI. Use of a vascular reconstruction device to salvage acute ischemic occlusions refractory to traditional endovascular recanalization methods. J Neurosurg. 2010 Mar;112(3):557-62. doi: 10.3171/2009.8.JNS09231.

    PubMed 19764826

  • Flint AC, Duckwiler GR, Budzik RF, Liebeskind DS, Smith WS; MERCI and Multi MERCI Writing Committee. Mechanical thrombectomy of intracranial internal carotid occlusion: pooled results of the MERCI and Multi MERCI Part I trials. Stroke. 2007 Apr;38(4):1274-80. doi: 10.1161/01.STR.0000260187.33864.a7. Epub 2007 Mar 1.

    PubMed 17332445

  • Penumbra Pivotal Stroke Trial Investigators. The penumbra pivotal stroke trial: safety and effectiveness of a new generation of mechanical devices for clot removal in intracranial large vessel occlusive disease. Stroke. 2009 Aug;40(8):2761-8. doi: 10.1161/STROKEAHA.108.544957. Epub 2009 Jul 9.

    PubMed 19590057

  • Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO; SWIFT Trialists. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012 Oct 6;380(9849):1241-9. doi: 10.1016/S0140-6736(12)61384-1. Epub 2012 Aug 26.

    PubMed 22932715

  • Nogueira RG, Lutsep HL, Gupta R, Jovin TG, Albers GW, Walker GA, Liebeskind DS, Smith WS; TREVO 2 Trialists. Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet. 2012 Oct 6;380(9849):1231-40. doi: 10.1016/S0140-6736(12)61299-9. Epub 2012 Aug 26.

    PubMed 22932714

  • Broderick JP, Palesch YY, Demchuk AM, Yeatts SD, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, Silver FL, von Kummer R, Molina CA, Demaerschalk BM, Budzik R, Clark WM, Zaidat OO, Malisch TW, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Martin RH, Foster LD, Tomsick TA; Interventional Management of Stroke (IMS) III Investigators. Endovascular therapy after intravenous t-PA versus t-PA alone for stroke. N Engl J Med. 2013 Mar 7;368(10):893-903. doi: 10.1056/NEJMoa1214300. Epub 2013 Feb 7.

    PubMed 23390923

  • Yoshimura S, Sakai N, Okada Y, Kitagawa K, Kimura K, Tanahashi N, Hyogo T, Yamagami H, Egashira Y; Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry Investigators. Efficacy of endovascular treatment for acute cerebral large-vessel occlusion: analysis of nationwide prospective registry. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):1183-90. doi: 10.1016/j.jstrokecerebrovasdis.2013.10.014. Epub 2014 Jan 11.

    PubMed 24424332

  • Barber PA, Demchuk AM, Zhang J, Buchan AM. Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy. ASPECTS Study Group. Alberta Stroke Programme Early CT Score. Lancet. 2000 May 13;355(9216):1670-4. doi: 10.1016/s0140-6736(00)02237-6.

    PubMed 10905241

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Hyogo Medical University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death (time frame: 90 days after disease onset). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02818868, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in