UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022721 |
|---|---|
| Receipt number | R000024525 |
| Scientific Title | An analysis on validity of distribution of biomarkers, exploration of correlation between biomarker outliers and adverse events under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 2 study) |
| Date of disclosure of the study information | 2016/06/13 |
| Last modified on | 2020/06/17 09:25:25 |
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Basic information
Public title
An analysis on validity of distribution of biomarkers, exploration of correlation between biomarker outliers and adverse events under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 2 study)
Acronym
R-mark (CVI ARO 2) study
Scientific Title
An analysis on validity of distribution of biomarkers, exploration of correlation between biomarker outliers and adverse events under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 2 study)
Scientific Title:Acronym
R-mark (CVI ARO 2) 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 validate the distribution of PT value, and direct and indirect serum concentration obtained in our previous single center study (CVI ARO study 1), which conducted in patients with non-valvular atrial fibrillation under rivaroxaban, in multicenter population including different types of patients. To explore the reproducibility and the correlation with adverse events, and also to determine the factors affecting the adverse events.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Distribution of PT value (peak) by multiple reagents
(Compare with the results of CVI ARO study 1)
Key secondary outcomes
(1) Bleeding (ISTH major bleeding, clinically relevant non-major bleeding, etc.)
(2) Characteristics of HAS-BLED, CHADS2, and CHA2DS2VASc in patients with outlier of PT values and direct and indirect serum concentration.
(3) Adverse events in patients with outlier of PT values and direct and indirect serum concentration.
(4) Affecting factors for adverse events by outlier of PT values and direct and indirect serum concentration.
(5) Reproducibility of PT values and direct and indirect serum concentration
(6) All adverse events
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 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
400
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.
TEL
+81-3-3408-2151
yamt-tky@umin.ac.jp
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
The Cardiovascular Institute Academic Organization (CVI ARO)
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
+81334082151
sinsuz-tky@umin.net
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
| 2016 | Year | 06 | Month | 13 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment and follow-up were completed
Management information
Registered date
| 2016 | Year | 06 | Month | 13 | 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=R000024525
