UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028383 |
|---|---|
| Receipt number | 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 | 2020/06/17 18:20:15 |
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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 | Shinya |
| Middle name | |
| Last name | Suzuki |
Organization
The Cardiovascular Institute
Division name
Department of cardiovascular medicine
Zip code
106-0031
Address
3-2-19 Nishiazabu, Minato-Ku, Tokyo. ZIP: 106-0031
TEL
+81-3-3408-2151
sinsuz-tky@umin.net
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Matsuda |
Organization
Cardiovascular Institute Academic Research Organization (CVI ARO)
Division name
Head office
Zip code
106-0031
Address
3-2-19 Nishiazabu, Minato-Ku, Tokyo
TEL
+81-3-3408-2151
Homepage URL
matsuda@cvi.or.jp
Sponsor or person
Institute
Medical Science Department
Daiichi-Sankyo Co. LTD.
Institute
Department
Personal name
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
Ethical Committee of The Cardiovascular Institute
Address
Nishi-azabu 3-2-19, Minato-ku, Tokyo
Tel
03-3408-2151
matsuda@cvi.or.jp
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
https://www.cvi.or.jp/kenkyujo/cviaro.html#link01
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00380-019-01438-6
Number of participants that the trial has enrolled
106
Results
1) PC-Ed by LC-MS/MS was 194.3 (49.4-345.3) and 17.0 (4.8-40.7) ng/mL at peak and trough.
2) Correlation of PT with PC-Ed was higher than that of aPTT.
3) Among 6 PT reagents, Coagupia PT-N and Simplastin Excel S (both PT reagents) showed the highest predictive capability for the upper outlier of PC-Ed at peak and trough.
Results date posted
| 2020 | Year | 06 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Consecutive NVAF patients under edoxaban therapy were evaluated.
Participant flow
Outpatients of the Cardiovascular Institute
Adverse events
All-cause death, stroke, systemic embolism, bleeding requiring hospitalization,
and cardiovascular events requiring hospitalization were not observed during the observation period.
Outcome measures
Plasma concentration of edoxaban, PT, and aPTT
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 25 | Day |
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
Main paper was published.
Management information
Registered date
| 2017 | Year | 07 | Month | 26 | Day |
Last modified on
| 2020 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032492
