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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035921
Receipt No. R000040904
Scientific Title Prospective exploratory study on the effect of oral administration of apixaban in vascular endothelial function in patients with non-valvular atrial fibrillation
Date of disclosure of the study information 2019/02/18
Last modified on 2019/02/18

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Basic information
Public title Prospective exploratory study on the effect of oral administration of apixaban in vascular endothelial function in patients with non-valvular atrial fibrillation
Acronym Prospective study on the effect of apixaban on vascular endothelial function
Scientific Title Prospective exploratory study on the effect of oral administration of apixaban in vascular endothelial function in patients with non-valvular atrial fibrillation
Scientific Title:Acronym Prospective study on the effect of apixaban on vascular endothelial function
Region
Japan

Condition
Condition Non-valvular atrial fibrillation patients
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the present study, it is prospectively examined whether improvement of vascular endothelial function by oral administration of new anticoagulant for patients with non-valvular atrial fibrillation using EndoPAT (manufactured by Itamar medical), and also examined the relationship of inflammatory response, vascular endothelial function, coagulation fibrinolytic marker using blood collection and urine analysis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes vascular endothelial function
Key secondary outcomes Lab test (General peripheral blood, total protein, albumin, CK, Cr, AST, ALT, gamma-GTP, TG, LDL, HDL, oxidant LDL, hs TNF-alfa, IL-6, Adiponectin, Thrombomodulin, hs CRP, ADMA, Insulin, fibrinogen, D-dimer, TAT, PIC, F1+2, PAI-1, BNP, 8-OHdG/CRE)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 single arm study, open(masking not used),uncontrolled control, single assignment, treatment purpose
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
100 years-old >
Gender Male and Female
Key inclusion criteria Subjects are 50 patients that consented for consecutive cases of eligible non-valvular atrial fibrillation patients (at least 15 paroxysmal atrial fibrillation cases and at least 15 sustained atrial fibrillation cases). Also, more than 5 subjects with 2 CHADS2 scores and more than 5 subjects with 3 or more CHADSS2 scores are entered respectively.
Key exclusion criteria 1) Patients contraindicated for anticoagulant drug
2) Patients complicated of malignant tumor
3) Patients who have orally ingested anticoagulant within 6 months
4) Patients who judged ineligible from the examining physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taro Adachi
Organization Showa University School of Medicine
Division name Division of Cardiology, Department of Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8539
Email adachitaro@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taro Adachi
Organization Showa University School of Medicine
Division name Division of Cardiology, Department of Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8539
Homepage URL
Email adachitaro@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine
Institute
Department

Funding Source
Organization Bristol-Myers Squibb K.K.
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
2019 Year 02 Month 18 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 18 Day
Last modified on
2019 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040904

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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