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
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
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
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
