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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028383
Receipt No. R000032492
Scientific Title An analysis on distribution and inter-relationships of biomarkers under edoxaban in Japanese patients with non-valvular atrial fibrillation
Date of disclosure of the study information 2017/07/26
Last modified on 2017/07/26

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Basic information
Public title An analysis on distribution and inter-relationships of biomarkers under edoxaban in Japanese patients with non-valvular atrial fibrillation
Acronym CVI ARO 7 study
Scientific Title An analysis on distribution and inter-relationships of biomarkers under edoxaban in Japanese patients with non-valvular atrial fibrillation
Scientific Title:Acronym CVI ARO 7 study
Region
Japan

Condition
Condition Patients with non-valvular atrial fibrillation who are taking edoxaban for prevention of ischemic stroke
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the distribution of serum concentration of edoxaban measured by LC/MS/MS and anti-Xa assay in patients with non-valvular atrial fibrillation, and determine the 90% interval.
To evaluate the distribution of PT and aPTT values in patients with non-valvular atrial fibrillation under edoxaban, and determine the 90% interval.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1) Distribution of serum concentration of edoxaban and its 90% interval
2) PT and APTT under edoxaban and its 90% interval

Key secondary outcomes All adverse events during the observation period

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 Patients with non-valvular atrial fibrillation (including paroxysmal atrial fibrillation) who are taking edoxaban.
Eligible conditions are follows:
1) Taking edoxaban for more than 2 weeks.
2) Age >= 20 years
3) Given informed consent.

Key exclusion criteria (1) Receiving dual anti-platelet therapy
(2) Inadequate dosage of edoxaban at registration
(3) Edoxaban hypersensitivity
(4) Patients who are bleeding
(5) Patients with acute bacterial endocarditis
(6) Renal dysfunction (creatinine clearance <30 mL/min)
(7) River dysfunction with clotting disorder
(8) Patients who had admitted with cardiovascular disease (stroke, myocardial infarction, PCI, and heart failure) or bleeding requiring hospitalization within 1 month before the registration
(9) Patients who did not give written informed consents for this study
(10) Patients who are judged by the researchers as inadequate for this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Suzuki
Organization The Cardiovascular Institute
Division name Department of cardiovascular medicine
Zip code
Address 3-2-19 Nishiazabu, Minato-Ku, Tokyo. ZIP: 106-0031
TEL +81-3-3408-2151
Email sinsuz-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Kazumi Matsuda
Organization Cardiovascular Institute Academic Research Organization (CVI ARO)
Division name Head office
Zip code
Address 3-2-19 Nishiazabu, Minato-Ku, Tokyo
TEL +81-3-3408-2151
Homepage URL
Email matsuda@cvi.or.jp

Sponsor
Institute Medical Science Department
Daiichi-Sankyo Co. LTD.
Institute
Department

Funding Source
Organization Daiichi-Sankyo Co. LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 心臓血管研究所
The Cardiovascular Institute

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 26 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
2017 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 26 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In registration

Management information
Registered date
2017 Year 07 Month 26 Day
Last modified on
2017 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032492

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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