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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000022652
Receipt No. 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 2016/06/10

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Basic information
Public title Impact of Apixaban on clinical outcome of the patients with Large Vessel Occlusion or stenosis
Acronym ALVO trial
Scientific Title Impact of Apixaban on clinical outcome of the patients with Large Vessel Occlusion or stenosis
Scientific Title:Acronym ALVO trial
Region
Japan

Condition
Condition Acute ischemic stroke
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death and ischemic/bleeding events within 90 days after disease onset
Key secondary outcomes


Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Yoshimura
Organization Hyogo College of Medicine
Division name Department of Neurosurgery
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo 663-8501
TEL +81-798-45-6455
Email alvo@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Uchida
Organization Hyogo College of Medicine
Division name Department of Neurosurgery
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo 663-8501
TEL +81-798-45-6455
Homepage URL
Email alvo@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Bristol-Myers Squibb
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2016 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2016 Year 06 Month 08 Day
Last modified on
2016 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026114

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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