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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016424
Receipt No. 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

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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
Email 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
Email matsuda@cvi.or.jp

Sponsor
Institute The Cardiovascular Institute
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019074

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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