UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051183 |
|---|---|
| Receipt number | R000058367 |
| Scientific Title | An analysis on distribution of biomarkers and soluble fibrin monomer complex (SFMC) at trough under direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation patients with CHA2DS2-VASc score greater than 2 (CVI ARO 13) |
| Date of disclosure of the study information | 2023/05/29 |
| Last modified on | 2023/05/29 09:11:03 |
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Basic information
Public title
An analysis on distribution of biomarkers and soluble fibrin monomer complex (SFMC) at trough under direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation patients with CHA2DS2-VASc score greater than 2 (CVI ARO 13)
Acronym
CVI ARO 13 Study
Scientific Title
An analysis on distribution of biomarkers and soluble fibrin monomer complex (SFMC) at trough under direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation patients with CHA2DS2-VASc score greater than 2 (CVI ARO 13)
Scientific Title:Acronym
CVI ARO 13 Study
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the utility of SFMC at trough under direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation patients with CHA2DS2-VASc score greater than 2.
Basic objectives2
Others
Basic objectives -Others
The secondary purpose of this study was to evaluate the other biomarkers such as cTnI, hs-CRP, and BNP.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. 90% interval of DOAC concentration
2. Relationship between DOAC concentration and SFMC and D-dimer
3. Relationship between DOAC and relevant coagulation markers and inflammatory markers
Key secondary outcomes
Adverse events during follow up period.
1. Death (all-cause death, cardiovascular death, non cardiovascular death)
2. Stroke (ischemic stroke, intracranial hemorrhage, other)
3. Systemic embolism
4. Major bleeding needing hospitalization
5. Cardiovascular event needing hospitalization
6. Othrer
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
(1) CHA2DS2-VASc score higher than 2; (2) under the treatment with or intended to use direct factor Xa inhibitor (FXaI; rivaroxaban, apixaban, or edoxaban) in order to prevent stroke or systemic embolism by AF; (3) older than 20 years old at the enrollment; and (4) with written informed consent.
Key exclusion criteria
Patients with any of the following at the enrollment were excluded; (1) receiving antiplatelet therapy, (2) inadequate dosage of FXaI with the Japanese pharmaceutical reference; (3) FXaI hypersensitivity; (4) patients with active bleeding (intracranial hemorrhage or retroperitoneal hemorrhage or bleeding in other important organs); (5) patients with acute bacterial endocarditis; (6) renal dysfunction (creatinine clearance < 30 mL/min); (7) liver dysfunction with clotting disorder; (8) cardiovascular event (stroke, myocardial infarction, percutaneous coronary intervention, and admission with heart failure) or major bleeding with admission before one month of enrollment, (9) patients who did not provide written informed consent; and (10) patients who were judged by the researchers to be inappropriate for this study (i.e., incapable of understanding the study protocol due to dementia, intellectual disturbance, and/or psychiatric/psychosomatic disorder).
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
Cardiovascular Medicine
Zip code
106-0031
Address
Nishi-azabu 3-2-19, Minato-ku, Tokyo, Japan
TEL
03-3408-2151
s-suzuki@cvi.or.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Matsuda |
Organization
Cardiovascular Institute Academic Reserch Organization (CVI ARO)
Division name
Head Office
Zip code
1060031
Address
Nishi-azabu 3-2-19, Minato-ku, Tokyo, Japan
TEL
03-3408-2151
Homepage URL
matsuda@cvi.or.jp
Sponsor or person
Institute
The Cardiovascular Institute
Institute
Department
Personal name
Funding Source
Organization
Sekisui Medical Co.LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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, Japan
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 29 | 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
100
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
| 2019 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058367
