UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035921
Receipt number 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 19:09:55

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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 or person

Institute

Showa University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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