UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016424 |
|---|---|
| Receipt number | R000019074 |
| Scientific Title | An analysis on distribution and inter-relationships of biomarkers under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 1 study) |
| Date of disclosure of the study information | 2015/02/02 |
| Last modified on | 2020/06/17 18:06:23 |
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Basic information
Public title
An analysis on distribution and inter-relationships of biomarkers under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 1 study)
Acronym
An analysis on distribution and inter-relationships of biomarkers under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 1 study)
Scientific Title
An analysis on distribution and inter-relationships of biomarkers under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 1 study)
Scientific Title:Acronym
An analysis on distribution and inter-relationships of biomarkers under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 1 study)
Region
| Japan |
Condition
Condition
Patients with non-valvular atrial fibrillation who are taking rivaroxaban for primary prevention of ischemic stroke
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain the information regarding the clinical efficacy and the limitation of PT value in patients with non-valvular atrial fibrillation under rivaroxaban.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
PT values with multiple reagents and anti-Xa activity under rivaroxaban, and serum concentration of rivaroxaban
Key secondary outcomes
adverse events including ischemic stroke
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
| Not applicable |
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 rivaroxaban for primary
prevention of ischemic stroke (both of naive and experienced)
Key exclusion criteria
(1) Receiving dual anti-platelet therapy
(2) Inadequate dosage of rivaroxaban at PT measurement
(3) Rivaroxaban hypersensitivity
(4) River dysfunction with clotting disorder
(5) Moderate and high river dysfunction (Child-Pugh classification B or C)
(6) Renal dysfunction (creatinine clearance <30 mL/min)
(7) Women who are pregnant or may be pregnant
(8) Patients taking HIV protease inhibitor (ritonavir, atazanavir, indinavir, etc)
(9)Patients taking azole antimycotic agent (itraconazole, voriconazole, ketoconazole, etc., excluding fluconazole)
(10) Patients taking drugs containing cobicistat
(11) Patients taking drugs with CYP3A4 or strong P-glycoprotein derivant (rifampicin, phenytoin, carbamazepine, phenobarbital, Saint John's wort-containing food, etc.)
(12) Patients with acute bacterial endocarditis
(13) Patients who did not give written informed consents for this study
(14) 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 | Takeshi |
| Middle name | |
| Last name | Yamashita |
Organization
The Cardiovascular Institute
Division name
Director
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
The Cardio Vascular 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
The Cardiovascular Institute
Institute
Department
Personal name
Funding Source
Organization
Bayer HealthCare AG
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Germany
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
心臓血管研究所付属病院（東京都）/ The Cardiovascular Institute (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 02 | 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://www.sciencedirect.com/science/article/abs/pii/S1347436717302203?via%3Dihub
Number of participants that the trial has enrolled
101
Results
1) The pharmacokinetics of rivaroxaban were affected by creatinine clearance, alanine aminotransferase, and use of CYP3A4 or P-gp inhibitors.
2) PTs with 5 reagents werepredicted by pharmacodinamic models with SC, hematocrit, serum albumin, and age, with medium predicting ability (highest/lowest R2 = 0.746/0.658 in Recombiplastin/Thromborel S, respectively).
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 non-valvular atrial
fibrillation under rivaroxaban between Jan/June, 2015 were recruited.
Participant flow
Outpatients of the Cardiovascular Institute.
Adverse events
One bleeding
Outcome measures
Concentration and PT with 5 reagents at 2-4 hours after (peak) and before intake of
rivaroxaban (trough) were measured at outpatient clinic
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 30 | Day |
Other
Other related information
Final results were published.
Management information
Registered date
| 2015 | Year | 02 | Month | 02 | 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=R000019074
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